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    Also known as: 1051375-16-6, Gsk1349572, S/gsk1349572, Tivicay, Gsk-1349572, Gsk 1349572
    Molecular Formula
    C20H19F2N3O5
    Molecular Weight
    419.4  g/mol
    InChI Key
    RHWKPHLQXYSBKR-BMIGLBTASA-N
    FDA UNII
    DKO1W9H7M1
    Dolutegravir Sodium
    Dolutegravir is an orally bioavailable integrase strand-transfer inhibitor (INSTI), with activity against human immunodeficiency virus type 1 (HIV-1) infection. Upon oral administration, dolutegravir binds to the active site of integrase, an HIV enzyme that catalyzes the transfer of viral genetic material into human chromosomes. This prevents integrase from binding to retroviral deoxyribonucleic acid (DNA), and blocks the strand transfer step, which is essential for the HIV replication cycle. This prevents HIV-1 replication.
    Dolutegravir is a Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor. The mechanism of action of dolutegravir is as a HIV Integrase Inhibitor, and Multidrug and Toxin Extrusion Transporter 1 Inhibitor, and Organic Cation Transporter 2 Inhibitor.
    1 2D Structure

    Dolutegravir Sodium

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    (3S,7R)-N-[(2,4-difluorophenyl)methyl]-11-hydroxy-7-methyl-9,12-dioxo-4-oxa-1,8-diazatricyclo[8.4.0.03,8]tetradeca-10,13-diene-13-carboxamide
    2.1.2 InChI
    InChI=1S/C20H19F2N3O5/c1-10-4-5-30-15-9-24-8-13(17(26)18(27)16(24)20(29)25(10)15)19(28)23-7-11-2-3-12(21)6-14(11)22/h2-3,6,8,10,15,27H,4-5,7,9H2,1H3,(H,23,28)/t10-,15+/m1/s1
    2.1.3 InChI Key
    RHWKPHLQXYSBKR-BMIGLBTASA-N
    2.1.4 Canonical SMILES
    CC1CCOC2N1C(=O)C3=C(C(=O)C(=CN3C2)C(=O)NCC4=C(C=C(C=C4)F)F)O
    2.1.5 Isomeric SMILES
    C[C@@H]1CCO[C@@H]2N1C(=O)C3=C(C(=O)C(=CN3C2)C(=O)NCC4=C(C=C(C=C4)F)F)O
    2.2 Other Identifiers
    2.2.1 UNII
    DKO1W9H7M1
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. (4r,12as)-n-((2,4-difluorophenyl)methyl)-3,4,6,8,12,12a-hexahydro-7-hydroxy-4-methyl-6,8-dioxo-2h-pyrido(1',2':4,5)pyrazino(2,1-b)(1,3)oxazine-9-carboxamide

    2. (4r,9as)-5-hydroxy-4-methyl-6,10-dioxo-3,4,6,9,9a,10-hexahydro-2h-1-oxa-4a,8a-diaza-anthracene-7-carboxylic Acid- 2,4 Difluorobenzylamide

    3. (4s,12ar)-n-((2,4-difluorophenyl)methyl)-3,4,6,8,12,12a-hexahydro-7-hydroxy-4-methyl-6,8-dioxo-2h-pyrido(1',2':4,5)pyrazino(2,1-b)(1,3)oxazine-9-carboxamide

    4. (4s,12as)-n-((2,4-difluorophenyl)methyl)-3,4,6,8,12,12a-hexahydro-7-hydroxy-4-methyl-6,8-dioxo-2h-pyrido(1',2':4,5)pyrazino(2,1-b)(1,3)oxazine-9-carboxamide

    5. Dolutegravir S,r Isomer

    6. Dolutegravir S,s-isomer

    7. Dolutegravir Sodium

    8. Dolutegravir Sodium Monohydrate

    9. Gsk 1349572a

    10. Gsk-1349572

    11. Gsk-1349572a

    12. Gsk1349572a

    13. S-gsk1349572

    14. Tivicay

    15. Tivicay Pd

    2.3.2 Depositor-Supplied Synonyms

    1. 1051375-16-6

    2. Gsk1349572

    3. S/gsk1349572

    4. Tivicay

    5. Gsk-1349572

    6. Gsk 1349572

    7. Dolutegravir (gsk1349572)

    8. S-349572

    9. (4r,12as)-n-(2,4-difluorobenzyl)-7-hydroxy-4-methyl-6,8-dioxo-3,4,6,8,12,12a-hexahydro-2h-pyrido[1',2':4,5]pyrazino[2,1-b][1,3]oxazine-9-carboxamide

    10. Dolutegravir Dtg

    11. Dolutegravir [usan]

    12. Chebi:76010

    13. (4r,12as)-n-[(2,4-difluorophenyl)methyl]-3,4,6,8,12,12a-hexahydro-7-hydroxy-4-methyl-6,8-dioxo-2h-pyrido[1',2':4,5]pyrazino[2,1-b][1,3]oxazine-9-carboxamide

    14. Dko1w9h7m1

    15. Dolutegravir (usan)

    16. 1051375-16-6 (free)

    17. Tivicay (tn)

    18. (3s,7r)-n-[(2,4-difluorophenyl)methyl]-11-hydroxy-7-methyl-9,12-dioxo-4-oxa-1,8-diazatricyclo[8.4.0.0^{3,8}]tetradeca-10,13-diene-13-carboxamide

    19. (3s,7r)-n-[(2,4-difluorophenyl)methyl]-11-hydroxy-7-methyl-9,12-dioxo-4-oxa-1,8-diazatricyclo[8.4.0.03,8]tetradeca-10,13-diene-13-carboxamide

    20. S-gsk1349572

    21. Dolutegravir [usan:inn]

    22. Unii-dko1w9h7m1

    23. Soltegravir

    24. Hsdb 8152

    25. 3s3m

    26. 3s3n

    27. 3s3o

    28. (4r,12as)-n-[(2,4-difluorophenyl)methyl]-7-hydroxy-4-methyl-6,8-dioxo-3,4,12,12a-tetrahydro-2h-pyrido[[?]:[?]]pyrazino[[?]][1,3]oxazine-9-carboxamide

    29. Dolutegravir [mi]

    30. Dolutegravir [inn]

    31. Dolutegravir [vandf]

    32. Schembl82071

    33. Mls006011137

    34. Dolutegravir [who-dd]

    35. Gtpl7365

    36. Chembl1229211

    37. Dtxsid90909356

    38. Ex-a1695

    39. Bdbm50062551

    40. Mfcd20488027

    41. S2667

    42. Zinc58581064

    43. Akos025396657

    44. S/gsk-1349572

    45. Bcp9000620

    46. Ccg-268876

    47. Cs-0454

    48. Db08930

    49. Ncgc00346629-01

    50. Ncgc00346629-02

    51. 2h-pyrido(1',2':4,5)pyrazino(2,1-b)(1,3)oxazine-9-carboxamide, N-((2,4-difluorophenyl)methyl)-3,4,6,8,12,12a-hexahydro-7-hydroxy-4-methyl-6,8-dioxo-, (4r,12as)-

    52. Ac-28371

    53. As-75277

    54. Hy-13238

    55. Smr004702915

    56. S/gsk1349572,gsk1349572

    57. D10066

    58. A854801

    59. Q937224

    60. J-501471

    61. (3s,7r)-n-[(2,4-difluorophenyl)methyl]-11-hydroxy-7-methyl-9,12-dioxo-4-oxa-1,8-diazatricyclo[8.4.0.0(3),?]tetradeca-10,13-diene-13-carboxamide

    62. (4r,12.alpha.s)-n-((2,4-difluorophenyl)methyl)-7-hydroxy-4-methyl-6,8-dioxo-3,4,6,8,12,12.alpha.-hexahydro-2h-pyrido(1',2':4,5)pyrazino(2,1-.beta.)(1,3)oxazine-9-carboxamide

    63. (4r,12as)-n-(2,4-difluorobenzyl)-7-hydroxy-4-methyl-6,8-dioxo-3,4,6,8,12,12a-hexahydro-2h-[1,3]oxazino[3,2-a]pyrido[1,2-d]pyrazine-9-carboxamide

    64. (4r,12as)-n-(2,4-difluorobenzyl)-7-hydroxy-4-methyl-6,8-dioxo-3,4,6,8,12,12a-hexahydro-2h-[1,3]oxazino[3,2-d]pyrido[1,2-a]pyrazine-9-carboxamide

    65. (4r,12as)-n-(2,4-difluorobenzyl)-7-hydroxy-4-methyl-6,8-dioxo-3,4,6,8,12,12a-hexahydro-2h-pyrido[1,2:4,5]pyrazino[2,1-b][1,3]oxazine-9-carboxamide

    66. (4r,12as)-n-[(2,4-difluorophenyl)methyl]-3,4,6,8,12,12a-hexahydro-7-hydroxy-4-methyl-6,8-dioxo-2h-pyrido[1',2':4,5]pyrazino[2,1-b][1 ,3]oxazine-9-carboxamide

    67. (4r,12as)-n-[(2,4-difluorophenyl)methyl]-7-hydroxy-4-methyl-6,8-dioxo-3,4,12,12a-tetrahydro-2h-pyrido[5,6]pyrazino[2,6-b][1,3]oxazine-9-carboxamide

    2.4 Create Date
    2011-12-26
    3 Chemical and Physical Properties
    Molecular Weight 419.4 g/mol
    Molecular Formula C20H19F2N3O5
    XLogP32.4
    Hydrogen Bond Donor Count2
    Hydrogen Bond Acceptor Count8
    Rotatable Bond Count3
    Exact Mass419.12927704 g/mol
    Monoisotopic Mass419.12927704 g/mol
    Topological Polar Surface Area99.2 Ų
    Heavy Atom Count30
    Formal Charge0
    Complexity829
    Isotope Atom Count0
    Defined Atom Stereocenter Count2
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count1
    4 Drug and Medication Information
    4.1 Therapeutic Uses

    HIV Integrase Inhibitors

    National Library of Medicine's Medical Subject Headings. Dolutegravir. Online file (MeSH, 2014). Available from, as of November 19, 2013: https://www.nlm.nih.gov/mesh/2014/mesh_browser/MBrowser.html

    The recommended dose of TIVICAY in pediatric patients aged 12 years and older and weighing at least 40 kg is 50 mg administered orally once daily. If efavirenz, fosamprenavir/ritonavir, tipranavir/ritonavir, or rifampin are coadministered, the recommended dose of TIVICAY is 50 mg twice daily. Safety and efficacy of TIVICAY have not been established in pediatric patients younger than 12 years or weighing less than 40 kg, or in pediatric patients who are INSTI-experienced with documented or clinically suspected resistance to other INSTIs (raltegravir, elvitegravir).

    US Natl Inst Health; DailyMed. Current Medication Information for TIVICAY (dolutegravir sodium) tablet, film coated TIVICAY (dolutegravir) Tablets for Oral Use (Initial U.S. Approval: 2013). Available from, as of November 22, 2013: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=63df5af3-b8ac-4e76-9830-2dbb340af922

    TIVICAY (dolutegravir) is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and children aged 12 years and older and weighing at least 40 kg. The following should be considered prior to initiating treatment with TIVICAY: Poor virologic response was observed in subjects treated with TIVICAY 50 mg twice daily with an integrase strand transfer inhibitor (INSTI)-resistance Q148 substitution plus 2 or more additional INSTI-resistance substitutions, including L74I/M, E138A/D/K/T, G140A/S, Y143H/R, E157Q, G163E/K/Q/R/S, or G193E/R.

    US Natl Inst Health; DailyMed. Current Medication Information for TIVICAY (dolutegravir sodium) tablet, film coated TIVICAY (dolutegravir) Tablets for Oral Use (Initial U.S. Approval: 2013). Available from, as of November 22, 2013: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=63df5af3-b8ac-4e76-9830-2dbb340af922

    Renal clearance of unchanged drug is a minor pathway of elimination for dolutegravir. In a trial comparing 8 subjects with severe renal impairment (CrCl <30 mL/min) with 8 matched healthy controls, AUC, Cmax, and C24 of dolutegravir were decreased by 40%, 23%, and 43%, respectively, compared with those in matched healthy subjects. The cause of this decrease is unknown. Population pharmacokinetic analysis using data from SAILING and VIKING-3 trials indicated that mild and moderate renal impairment had no clinically relevant effect on the exposure of dolutegravir. No dosage adjustment is necessary for treatment-naive or treatment-experienced and INSTI-naive patients with mild, moderate, or severe renal impairment or for INSTI-experienced patients (with certain INSTI-associated resistance substitutions or clinically suspected INSTI resistance) with mild or moderate renal impairment. Caution is warranted for INSTI-experienced patients (with certain INSTI-associated resistance substitutions or clinically suspected INSTI resistance [see Microbiology (12.4)]) with severe renal impairment, as the decrease in dolutegravir concentrations may result in loss of therapeutic effect and development of resistance to TIVICAY or other coadministered antiretroviral agents. Dolutegravir has not been studied in patients requiring dialysis.

    US Natl Inst Health; DailyMed. Current Medication Information for TIVICAY (dolutegravir sodium) tablet, film coated TIVICAY (dolutegravir) Tablets for Oral Use (Initial U.S. Approval: 2013). Available from, as of November 22, 2013: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=63df5af3-b8ac-4e76-9830-2dbb340af922

    Dolutegravir is primarily metabolized and eliminated by the liver. In a trial comparing 8 subjects with moderate hepatic impairment (Child-Pugh Score B) with 8 matched healthy controls, exposure of dolutegravir from a single 50-mg dose was similar between the 2 groups. No dosage adjustment is necessary for patients with mild to moderate hepatic impairment (Child-Pugh Score A or B). The effect of severe hepatic impairment (Child-Pugh Score C) on the pharmacokinetics of dolutegravir has not been studied. Therefore, TIVICAY is not recommended for use in patients with severe hepatic impairment.

    US Natl Inst Health; DailyMed. Current Medication Information for TIVICAY (dolutegravir sodium) tablet, film coated TIVICAY (dolutegravir) Tablets for Oral Use (Initial U.S. Approval: 2013). Available from, as of November 22, 2013: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=63df5af3-b8ac-4e76-9830-2dbb340af922

    4.2 Drug Warning

    The Centers for Disease Control and Prevention recommend that HIV-1-infected mothers in the United States not breastfeed their infants to avoid risking postnatal transmission of HIV-1 infection. Studies in lactating rats and their offspring indicate that dolutegravir was present in rat milk. It is not known whether dolutegravir is excreted in human milk. Because of both the potential for HIV transmission and the potential for adverse reactions in nursing infants, mothers should be instructed not to breastfeed if they are receiving TIVICAY.

    US Natl Inst Health; DailyMed. Current Medication Information for TIVICAY (dolutegravir sodium) tablet, film coated TIVICAY (dolutegravir) Tablets for Oral Use (Initial U.S. Approval: 2013). Available from, as of November 22, 2013: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=63df5af3-b8ac-4e76-9830-2dbb340af922

    Pregnancy Category B. There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, and dolutegravir was shown to cross the placenta in animal studies, this drug should be used during pregnancy only if clearly needed.

    US Natl Inst Health; DailyMed. Current Medication Information for TIVICAY (dolutegravir sodium) tablet, film coated TIVICAY (dolutegravir) Tablets for Oral Use (Initial U.S. Approval: 2013). Available from, as of November 22, 2013: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=63df5af3-b8ac-4e76-9830-2dbb340af922

    Dolutegravir (TIVICAY) should not be used with etravirine without coadministration of atazanavir/ritonavir, darunavir/ritonavir, or lopinavir/ritonavir.

    US Natl Inst Health; DailyMed. Current Medication Information for TIVICAY (dolutegravir sodium) tablet, film coated TIVICAY (dolutegravir) Tablets for Oral Use (Initial U.S. Approval: 2013). Available from, as of November 22, 2013: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=63df5af3-b8ac-4e76-9830-2dbb340af922

    Immune reconstitution syndrome has been reported in patients treated with combination antiretroviral therapy, including TIVICAY. During the initial phase of combination antiretroviral treatment, patients whose immune systems respond may develop an inflammatory response to indolent or residual opportunistic infections (such as Mycobacterium avium infection, cytomegalovirus, Pneumocystis jirovecii pneumonia (PCP), or tuberculosis), which may necessitate further evaluation and treatment. Autoimmune disorders (such as Graves' disease, polymyositis, and Guillain-Barre syndrome) have also been reported to occur in the setting of immune reconstitution; however, the time to onset is more variable and can occur many months after initiation of treatment.

    US Natl Inst Health; DailyMed. Current Medication Information for TIVICAY (dolutegravir sodium) tablet, film coated TIVICAY (dolutegravir) Tablets for Oral Use (Initial U.S. Approval: 2013). Available from, as of November 22, 2013: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=63df5af3-b8ac-4e76-9830-2dbb340af922

    For more Drug Warnings (Complete) data for Dolutegravir (8 total), please visit the HSDB record page.

    4.3 Drug Indication

    Dolutegravir is indicated in combination with other antiretroviral agents for the treatment of patients with HIV-1 infection that comply with the characteristics of being adults or children aged 12 years and older and present at least a weight of 40 kg. The FDA combination therapy approval of dolutegravir and rilpivirine is indicated for adults with HIV-1 infections whose virus is currently suppressed (< 50 copies/ml) on a stable regimen for at least six months, without history of treatment failure and no known substitutions associated to resistance to any of the two components of the therapy.

    FDA Label

    Tivicay is indicated in combination with other anti-retroviral medicinal products for the treatment of Human Immunodeficiency Virus (HIV) infected adults, adolescents and children of at least 6 years of age or older and weighing at least 14 kg.

    Tivicay is indicated in combination with other anti-retroviral medicinal products for the treatment of Human Immunodeficiency Virus (HIV) infected adults, adolescents and children of at least 4 weeks of age or older and weighing at least 3 kg.

    5 Pharmacology and Biochemistry
    5.1 Pharmacology

    HIV-1 infected subjects on dolutegravir monotherapy demonstrated rapid and dose-dependent reduction of antiviral activity with declines of HIV-1 RNA copies per ml. The antiviral response was maintained for 3 to 4 days after the last dose. The sustained response obtained in clinical trials indicates that dolutegravir has a tight binding and longer dissociative half-life providing it a high barrier to resistance. The combination therapy (ripivirine and dolutegravir) presented the same viral suppression found in previous three-drug therapies without integrase strand transfer inhibitor mutations or rilpivirine resistance.

    5.2 MeSH Pharmacological Classification

    HIV Integrase Inhibitors

    Inhibitors of HIV INTEGRASE, an enzyme required for integration of viral DNA into cellular DNA. (See all compounds classified as HIV Integrase Inhibitors.)

    5.3 FDA Pharmacological Classification
    5.3.1 Active Moiety
    DOLUTEGRAVIR
    5.3.2 FDA UNII
    DKO1W9H7M1
    5.3.3 Pharmacological Classes
    Mechanisms of Action [MoA] - Organic Cation Transporter 2 Inhibitors
    5.4 ATC Code

    J05AX12

    J - Antiinfectives for systemic use

    J05 - Antivirals for systemic use

    J05A - Direct acting antivirals

    J05AJ - Integrase inhibitors

    J05AJ03 - Dolutegravir

    5.5 Absorption, Distribution and Excretion

    Absorption

    When 50 mg of dolutegravir once daily was orally administered to HIV-1 infected adults, the AUC, Cmax, and Cmin is 53.6 mcg h/mL, 3.67 mcg/mL, and 1.11 mcg/mL, respectively. The peak plasma concentration was observed 2 to 3 hours post-dose. Steady state is achieved within approximately 5 days with average accumulation ratios for AUC, Cmax, and C24h ranging from 1.2 to 1.5. When 50 mg once daily is given to pediatric patients (12 to < 18 years and weighing 40 kg) the Cmax, AUC, and C24 is 3.49 mcg/mL, 46 mcg.h/mL, and 0.90 mcg/mL respectively.

    Route of Elimination

    When a single oral dose of dolutegravir is given, nearly all complete dose is recovered in a proportion of 53% excreted unchanged in the feces and 31% excreted in urine. The renal eliminated recovered dose consists of ether glucuronide of dolutegravir (18.9%), a metabolite formed by oxidation at the benzylic carbon (3.0%), a hydrolytic N-dealkylation product (3.6%) and unchanged drug (< 1%).

    Volume of Distribution

    The administration of a dose of 50 mg of dolutegravir presents an apparent volume of distribution of 17.4 L. The median dolutegravir concentration in CSF was 18 ng/mL after 2 weeks of treatment.

    Clearance

    The apparent clearance rate of dultegravir is 1.0 L/h.

    ... After a single oral dose of [14C] dolutegravir, 53% of the total oral dose was excreted unchanged in feces. Thirty-one percent of the total oral dose was excreted in urine, represented by an ether glucuronide of dolutegravir (18.9% of total dose), a metabolite formed by oxidation at the benzylic carbon (3.0% of total dose), and its hydrolytic N-dealkylation product (3.6% of total dose). Renal elimination of unchanged drug was low (<1% of the dose).

    US Natl Inst Health; DailyMed. Current Medication Information for TIVICAY (dolutegravir sodium) tablet, film coated TIVICAY (dolutegravir) Tablets for Oral Use (Initial U.S. Approval: 2013). Available from, as of November 22, 2013: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=63df5af3-b8ac-4e76-9830-2dbb340af922

    Dolutegravir is highly bound (=98.9%) to human plasma proteins based on in vivo data and binding is independent of plasma concentration of dolutegravir. The apparent volume of distribution (Vd/F) following 50-mg once-daily administration is estimated at 17.4 L based on a population pharmacokinetic analysis.

    US Natl Inst Health; DailyMed. Current Medication Information for TIVICAY (dolutegravir sodium) tablet, film coated TIVICAY (dolutegravir) Tablets for Oral Use (Initial U.S. Approval: 2013). Available from, as of November 22, 2013: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=63df5af3-b8ac-4e76-9830-2dbb340af922

    Food increased the extent of absorption and slowed the rate of absorption of dolutegravir. Low-, moderate-, and high-fat meals increased dolutegravir AUC(0-8) by 33%, 41%, and 66%; increased Cmax by 46%, 52%, and 67%; and prolonged Tmax to 3, 4, and 5 hours from 2 hours under fasted conditions, respectively.

    US Natl Inst Health; DailyMed. Current Medication Information for TIVICAY (dolutegravir sodium) tablet, film coated TIVICAY (dolutegravir) Tablets for Oral Use (Initial U.S. Approval: 2013). Available from, as of November 22, 2013: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=63df5af3-b8ac-4e76-9830-2dbb340af922

    Following oral administration of dolutegravir, peak plasma concentrations were observed 2 to 3 hours postdose. With once-daily dosing, pharmacokinetic steady state is achieved within approximately 5 days with average accumulation ratios for AUC, Cmax, and C24 h ranging from 1.2 to 1.5. Dolutegravir plasma concentrations increased in a less than dose-proportional manner above 50 mg. Dolutegravir is a P-glycoprotein substrate in vitro. The absolute bioavailability of dolutegravir has not been established.

    US Natl Inst Health; DailyMed. Current Medication Information for TIVICAY (dolutegravir sodium) tablet, film coated TIVICAY (dolutegravir) Tablets for Oral Use (Initial U.S. Approval: 2013). Available from, as of November 22, 2013: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=63df5af3-b8ac-4e76-9830-2dbb340af922

    5.6 Metabolism/Metabolites

    Dolutegravir is highly metabolized through three main pathways and it forms no long-lived metabolites. The first pathway is defined by the glucuronidation by UGT1A1, the second pathway by carbon oxidation by CYP3A4 and the third pathway is what appears to be a sequential oxidative defluorination and glutathione conjugation. The main metabolite found in blood plasma is the ether glucuronide form (M2) and its chemical properties disrupt its ability to bind metal ions, therefore, it is inactive.

    Dolutegravir is primarily metabolized via UGT1A1 with some contribution from CYP3A. ... ether glucuronide of dolutegravir (18.9% of total dose), a metabolite formed by oxidation at the benzylic carbon (3.0% of total dose), and its hydrolytic N-dealkylation product (3.6% of total dose). ...

    US Natl Inst Health; DailyMed. Current Medication Information for TIVICAY (dolutegravir sodium) tablet, film coated TIVICAY (dolutegravir) Tablets for Oral Use (Initial U.S. Approval: 2013). Available from, as of November 22, 2013: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=63df5af3-b8ac-4e76-9830-2dbb340af922

    5.7 Biological Half-Life

    The half-life of dolutegravir is 14 hours.

    Dolutegravir has a terminal half-life of approximately 14 hours and an apparent clearance (CL/F) of 1.0 L/h based on population pharmacokinetic analyses.

    US Natl Inst Health; DailyMed. Current Medication Information for TIVICAY (dolutegravir sodium) tablet, film coated TIVICAY (dolutegravir) Tablets for Oral Use (Initial U.S. Approval: 2013). Available from, as of November 22, 2013: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=63df5af3-b8ac-4e76-9830-2dbb340af922

    5.8 Mechanism of Action

    Dolutegravir is an HIV-1 antiviral agent. It inhibits HIV integrase by binding to the active site and blocking the strand transfer step of retroviral DNA integration in the host cell. The strand transfer step is essential in the HIV replication cycle and results in the inhibition of viral activity. Dolutegravir has a mean EC50 value of 0.5 nM (0.21 ng/mL) to 2.1 nM (0.85 ng/mL) in peripheral blood mononuclear cells (PBMCs) and MT-4 cells.

    Dolutegravir inhibits HIV integrase by binding to the integrase active site and blocking the strand transfer step of retroviral deoxyribonucleic acid (DNA) integration which is essential for the HIV replication cycle. Strand transfer biochemical assays using purified HIV-1 integrase and pre-processed substrate DNA resulted in IC50 values of 2.7 nM and 12.6 nM.

    US Natl Inst Health; DailyMed. Current Medication Information for TIVICAY (dolutegravir sodium) tablet, film coated TIVICAY (dolutegravir) Tablets for Oral Use (Initial U.S. Approval: 2013). Available from, as of November 22, 2013: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=63df5af3-b8ac-4e76-9830-2dbb340af922

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    Dolutegravir Sodium

    About the Company : LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, ...

    LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, analytical method development and testing, and commercial manufacturing. LGM Pharma offers custom API synthesis, analytical development, and regulatory services. With a network of over 300 accredited CGMP manufacturing partners, LGM provides unparalleled supply chain security. And, with over 100,000 square feet of FDA-inspected cGMP manufacturing and warehouse capacity, LGM Pharma provides a one-stop solution for solid dose, powder, semi-solid and liquid drugs.
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    02

    HRV Global Life Sciences

    India
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    CPhI India 2024
    Booth #2.D38
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    Virtual BoothHRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.

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    Dolutegravir Sodium

    About the Company : HRV Global is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It...

    HRV Global is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It offers services such as sourcing, manufacturing and supply, helping partners enter new markets worldwide. Its strong partnerships with major players in the pharma and food additive industries help HRV Global effectively promote projects and products. HRV Global represents over 30 large Indian drugmakers, primarily targeting Europe, the US and the Middle East markets. Headquartered in India, HRV Global has offices in the US, Switzerland, Dubai, Lithuania & Turkey.
    HRV Global Life Sciences

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    03

    Porton Pharma Solutions

    China
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    SupplySide West 2024
    Not Confirmed
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    Virtual BoothPorton Pharma Solutions: Value creation via innovation & discovery through technical platforms.

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    Dolutegravir Sodium

    About the Company : Porton Pharma Solutions Ltd. was founded in 2005, & the company's stock was successfully listed in Shenzhen Stock Exchange in 2014. Our R&D, manufacturing & operation facilities ar...

    Porton Pharma Solutions Ltd. was founded in 2005, & the company's stock was successfully listed in Shenzhen Stock Exchange in 2014. Our R&D, manufacturing & operation facilities are located in China, Slovenia, the US, Belgium, Switzerland, Denmark, with more than 6000 employees worldwide. Porton leads the way with its excellent CDMO services, but also supplies APIs & intermediates for the treatment of critical diseases such as HIV/AIDS, diabetes, cancer, & influenza. Our Process Technology Centers & WHO/USFDA/EMA/PDMA/NMPA-inspected Facilities feature state-of-the-art equipment, highly flexible cGMP-compliant production assets.
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    04

    Chromo Laboratories

    India
    SupplySide West 2024
    Not Confirmed
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    Chromo Laboratories

    India
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    Dolutegravir Sodium

    About the Company : Chromo Laboratories India Pvt. Ltd, is a Hyderabad based Manufacturer of Intermediates and Active Pharmaceutical Ingredients. The manufacturing facility is located at Pashamylaram...

    Chromo Laboratories India Pvt. Ltd, is a Hyderabad based Manufacturer of Intermediates and Active Pharmaceutical Ingredients. The manufacturing facility is located at Pashamylaram, Near Patancheru, Which is 27 KM from Hyderabad. It aggressively engage in expanding product portfolio strategy and focuses on its growth . Chromo Laboratories India views its fully equipped R&D centre capabilities as a vital component of its business strategy that will provide the company with a sustainable, long-term competitive advantage. It is focusing on providing cost effective products to the Pharmaceutical Market. 
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    05

    Guangdong Raffles PharmaTech Co Ltd

    China
    SupplySide West 2024
    Not Confirmed
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    Guangdong Raffles PharmaTech Co Ltd

    China
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    Not Confirmed
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    Dolutegravir (GSK1349572)

    About the Company : Established in August 2011, Raffles PharmaTech is a high-tech enterprise that focus on development, manufacturing and sales of high-value added active pharmaceutical ingredients an...

    Established in August 2011, Raffles PharmaTech is a high-tech enterprise that focus on development, manufacturing and sales of high-value added active pharmaceutical ingredients and intermediates. We are specialized in applying organic catalysts into the process development to lower cost, and to provide cost-effective product and service to customers. With our strong R&D capability and our proprietary organic catalysts, we provide low cost and high quality active pharmaceutical ingredients and intermediates to pharmaceutical companies. We also provide world standard process development, custom synthesis and manufacturing service.
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    06

    Guangzhou Tosun Pharmaceutical

    China
    SupplySide West 2024
    Not Confirmed
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    Guangzhou Tosun Pharmaceutical

    China
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    Not Confirmed
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    Dolutegravir

    About the Company : Guangzhou Tosun Pharmaceutical was founded in 1999, which mainly focuses on importation & exportation of Active Pharmaceutical Ingrediants, Chemical Raw Materials, Intermediate, Ex...

    Guangzhou Tosun Pharmaceutical was founded in 1999, which mainly focuses on importation & exportation of Active Pharmaceutical Ingrediants, Chemical Raw Materials, Intermediate, Excipients, Herbal extracts, Formulation of Chinese & Western Medicine. With abundant economic strength, the group has successfully developed to a pharmaceutical group enterprise wich intergrets operation of medicine & related products, processing & manufacturing, and importation & exportation together.
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    07

    Hetero Drugs

    India
    SupplySide West 2024
    Not Confirmed
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    Hetero Drugs

    India
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    Not Confirmed
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    Dolutegravir

    About the Company : Hetero is a research based global pharmaceutical company focused on development, manufacturing and marketing of Active Pharmaceutical Ingredients (APIs), Intermediate Chemicals & F...

    Hetero is a research based global pharmaceutical company focused on development, manufacturing and marketing of Active Pharmaceutical Ingredients (APIs), Intermediate Chemicals & Finished Dosages. Ever since its establishment in 1993, Hetero showed a tradition of excellence and deep sense of commitment in developing cost effective processes to offer wide range of affordable drugs. Hetero is building on the strengths of vertical integration in discovery research, process chemistry, API manufacturing, formulation development and commercialization.
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    08

    Shenzhen HwaGen Pharmaceutical

    China
    SupplySide West 2024
    Not Confirmed
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    Shenzhen HwaGen Pharmaceutical

    China
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    Not Confirmed
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    DOLUTEGRAVIR SODIUM

    About the Company : Shenzhen HwaGen Pharmaceutical Co., Ltd. (HwaGen Pharma) was founded in December of 2015 under the leadership of a “National 1000 Talents Program” expert. By leveraging its cor...

    Shenzhen HwaGen Pharmaceutical Co., Ltd. (HwaGen Pharma) was founded in December of 2015 under the leadership of a “National 1000 Talents Program” expert. By leveraging its core competency in chiral synthesis, enzymatic catalysis and continuous flow micro reactor, HwaGen Pharmaceutical is dedicated to development and manufacturing of specialty and niche intermediates and APIs covering various therapeutic areas including oncology, antiviral and respiratory, delivering high value-added and affordable products for global pharmaceutical industry. Equipments for Analysis & Test include Tabletop NMR, LC-MS, GC, HPLC etc.
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    09

    Sms Lifesciences

    India
    SupplySide West 2024
    Not Confirmed
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    Sms Lifesciences

    India
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    Dolutegravir

    About the Company : SMS Lifesciences is a global player in APIs/Intermediates manufacturing having a strong research and manufacturing team supported by state of the art facilities. What started off a...

    SMS Lifesciences is a global player in APIs/Intermediates manufacturing having a strong research and manufacturing team supported by state of the art facilities. What started off as a single facility - single product manufacturing company in 1990 grew to be a multi-location group having products spread across an array of therapeutic segments. SMS Group was given the export house status in the year 1997-98. SMS Lifesciences is currently a public listed company having ever appreciating International and Domestic customer base.
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    10

    Viatris

    U.S.A
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    Viatris

    U.S.A
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    Dolutegravir

    About the Company : In November 2020, Viatris was formed through the combination of Mylan and Upjohn, with a mission of empowering people worldwide to live healthier at every stage of life. Viatris (N...

    In November 2020, Viatris was formed through the combination of Mylan and Upjohn, with a mission of empowering people worldwide to live healthier at every stage of life. Viatris (NASDAQ: VTRS) is a global healthcare company empowering people worldwide to live healthier at every stage of life. We provide access to medicines, advance sustainable operations, develop innovative solutions and leverage our collective expertise to connect more people to more products and services through our one-of-a-kind Global Healthcare Gateway®. Formed in November 2020.
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    API Reference Price

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LIMITED","supplierCountry":"CHINA","foreign_port":"NANNING","customer":"CIPLA","customerCountry":"INDIA","quantity":"459.41","actualQuantity":"459.41","unit":"KGS","unitRateFc":"220","totalValueFC":"103381.5","currency":"USD","unitRateINR":"18679.4","date":"23-Sep-2023","totalValueINR":"8581513.23","totalValueInUsd":"103381.5","indian_port":"Bombay Air","hs_no":"29349990","bill_no":"7974749","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"NANNING","supplierAddress":"ADD: NO. 1479 ZHANGHENG ROAD,ZHANGJIANG HI-TECH PARK,SHANGHAI CHINA","customerAddress":"MUMBAI CENTRAL,"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q3","strtotime":1695580200,"product":"DOLUTEGRAVIR (DOLUTEGRAVIR SODIUM)","address":"MUMBAI CENTRAL,","city":"MUMBAI, MAHARASHTRA.","supplier":"DESANO LIMITED","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"CIPLA","customerCountry":"INDIA","quantity":"145.00","actualQuantity":"145","unit":"KGS","unitRateFc":"220","totalValueFC":"32300.4","currency":"USD","unitRateINR":"18491","date":"25-Sep-2023","totalValueINR":"2681195","totalValueInUsd":"32300.4","indian_port":"JNPT","hs_no":"29349990","bill_no":"7998525","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"1479 ZHANGHENG ROAD ZHANG JIANG HI-TECH PARK SHANGHAISDNF China","customerAddress":"MUMBAI CENTRAL,"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q3","strtotime":1695666600,"product":"DOLUTEGRAVIR SODIUM","address":"MUMBAI CENTRAL,","city":"MUMBAI, MAHARASHTRA.","supplier":"DESANO LIMITED","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"CIPLA","customerCountry":"INDIA","quantity":"30.00","actualQuantity":"30","unit":"KGS","unitRateFc":"460","totalValueFC":"13973.2","currency":"USD","unitRateINR":"38663","date":"26-Sep-2023","totalValueINR":"1159890","totalValueInUsd":"13973.2","indian_port":"JNPT","hs_no":"29349990","bill_no":"8007887","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"1479 ZHANGHENG ROAD ZHANG JIANG HI-TECH PARK SHANGHAISDNF China","customerAddress":"MUMBAI CENTRAL,"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1697221800,"product":"DOLUTEGRAVIR SODIUM","address":"2ND FLOOR, SERENE CHAMBERS,","city":"","supplier":"CIPLA","supplierCountry":"INDIA","foreign_port":"MOMBASA","customer":"LAURUS LABS","customerCountry":"INDIA","quantity":"1163.92","actualQuantity":"1163.917","unit":"KGS","unitRateFc":"320","totalValueFC":"387466.9","currency":"USD","unitRateINR":"27707","date":"14-Oct-2023","totalValueINR":"32248597.59","totalValueInUsd":"387466.9","indian_port":"Madras Air","hs_no":"29349990","bill_no":"8304564","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"MOMBASA","supplierAddress":"PLOT 1-7 1ST RING ROAD LUZIRAINDUSTRIAL PARK P.O.BOX.34871KAMALA UG","customerAddress":"2ND FLOOR, SERENE CHAMBERS,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1716402600,"product":"DOLUTEGRAVIR (DOLUTEGRAVIR SODIUM)","address":"MUMBAI CENTRAL,","city":"MUMBAI, MAHARASHTRA.","supplier":"DESANO LIMITED","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"CIPLA","customerCountry":"INDIA","quantity":"2028.57","actualQuantity":"2028.57","unit":"KGS","unitRateFc":"200","totalValueFC":"410561","currency":"USD","unitRateINR":"16870","date":"23-May-2024","totalValueINR":"34221975.9","totalValueInUsd":"410561","indian_port":"JNPT","hs_no":"29349990","bill_no":"3621771","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"1479 ZHANGHENG ROAD ZHANG JIANG HI-TECH PARK SHANGHAISDNF China","customerAddress":"MUMBAI CENTRAL,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1722105000,"product":"DOLUTEGRAVIR (DOLUTEGRAVIR SODIUM)","address":"MUMBAI CENTRAL,","city":"MUMBAI, MAHARASHTRA.","supplier":"DESANO LIMITED","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"CIPLA","customerCountry":"INDIA","quantity":"3617.00","actualQuantity":"3617","unit":"KGS","unitRateFc":"200","totalValueFC":"731698.6","currency":"USD","unitRateINR":"16910","date":"28-Jul-2024","totalValueINR":"61163470","totalValueInUsd":"731698.6","indian_port":"JNPT","hs_no":"29349990","bill_no":"4749482","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"1479 ZHANGHENG ROAD ZHANG JIANG HI-TECH PARK SHANGHAISDNF China","customerAddress":"MUMBAI CENTRAL,"}]
    07-Jan-2021
    26-Sep-2024
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    Average Price (USD/KGS)

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    Total Quantity (KGS)

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    Quantity (KGS) & Unit rate (USD/KGS) over time

    API Imports and Exports

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    Drugs in Development

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    • Development Update
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    Virtual BoothStrides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.

    Strides Receives Tentative USFDA Approval for Dolutegravir/ Lamivudine/Tenofovir Disproxil Fumurate Tablets

    Details:

    USFDA approved a combination drug Dolutegravir, Lamivudine and Tenofovir Disproxil Fumurate a complete regimen for treatment of HIV‐1 infection in adults and pediatric patients weighing at least 35kgs.


    Lead Product(s): Dolutegravir Sodium,Lamivudine,Tenofovir Disproxil Fumurate

    Therapeutic Area: Infections and Infectious Diseases Brand Name: Undisclosed

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable September 15, 2023

    Strides Pharma Science

    01

    Strides Pharma Science

    India
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    CPhI India 2024
    Attending
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothStrides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.

    Lead Product(s) : Dolutegravir Sodium,Lamivudine,Tenofovir Disproxil Fumurate

    Therapeutic Area : Infections and Infectious Diseases

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Strides Receives Tentative USFDA Approval for Dolutegravir/ Lamivudine/Tenofovir Disproxil Fumurat...

    Details : USFDA approved a combination drug Dolutegravir, Lamivudine and Tenofovir Disproxil Fumurate a complete regimen for treatment of HIV‐1 infection in adults and pediatric patients weighing at least 35kgs.

    Brand Name : Undisclosed

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    September 15, 2023

    Strides Pharma Science

    Stock Recap
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    Virtual Booth

    • Development Update
    • fda
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    Virtual BoothStrides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.

    Strides Receives Tentative USFDA Approval for Dolutegravir Tablets

    Details:

    USFDA approved a generic verion of Dolutegravir for the treatment of HIV‐1 infection in adults and pediatric patients weighing at least 35kgs. It inhibits HIV-integrase which is necessary for viral cell replication.


    Lead Product(s): Dolutegravir Sodium

    Therapeutic Area: Infections and Infectious Diseases Brand Name: Tivicay-Generic

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable September 14, 2023

    Strides Pharma Science

    02

    Strides Pharma Science

    India
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    CPhI India 2024
    Attending
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothStrides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.

    Lead Product(s) : Dolutegravir Sodium

    Therapeutic Area : Infections and Infectious Diseases

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Strides Receives Tentative USFDA Approval for Dolutegravir Tablets

    Details : USFDA approved a generic verion of Dolutegravir for the treatment of HIV‐1 infection in adults and pediatric patients weighing at least 35kgs. It inhibits HIV-integrase which is necessary for viral cell replication.

    Brand Name : Tivicay-Generic

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    September 14, 2023

    Strides Pharma Science

    Stock Recap
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    Virtual Booth

    • Development Update
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    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

    ViiV Healthcare Announces FDA Approval Of Dovato for Adolescents with HIV

    Details:

    Dovato (dolutegravir and lamivudine) is the first oral two-drug single-tablet regimen for people aged 12 and older living with HIV.


    Lead Product(s): Dolutegravir Sodium,Lamivudine

    Therapeutic Area: Infections and Infectious Diseases Brand Name: Dovato

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable April 08, 2024

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    03

    ViiV Healthcare

    United Kingdom
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    SupplySide West 2024
    Not Confirmed

    ViiV Healthcare

    United Kingdom
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    SupplySide West 2024
    Not Confirmed
    • fda
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    Lead Product(s) : Dolutegravir Sodium,Lamivudine

    Therapeutic Area : Infections and Infectious Diseases

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    ViiV Healthcare Announces FDA Approval Of Dovato for Adolescents with HIV

    Details : Dovato (dolutegravir and lamivudine) is the first oral two-drug single-tablet regimen for people aged 12 and older living with HIV.

    Brand Name : Dovato

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    April 08, 2024

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    ACTG Launches Tuberculosis Drug Interaction Trial Among HIV Patients

    Details:

    Dolutegravir is a HIV type 1 integrase inhibitor, which is being evaluated in combination with daily rifapentine-moxifloxacin plus isoniazid and pyrazinamide regimen for HIV-associated tuberculosis.


    Lead Product(s): Dolutegravir Sodium,Rifapentine,Moxifloxacin

    Therapeutic Area: Infections and Infectious Diseases Brand Name: Tivicay

    Study Phase: Phase IIProduct Type: Small molecule

    Sponsor: ViiV Healthcare

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable February 14, 2024

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    04

    ACTG

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    ACTG

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    SupplySide West 2024
    Not Confirmed
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    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

    Lead Product(s) : Dolutegravir Sodium,Rifapentine,Moxifloxacin

    Therapeutic Area : Infections and Infectious Diseases

    Highest Development Status : Phase II

    Partner/Sponsor/Collaborator : ViiV Healthcare

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    ACTG Launches Tuberculosis Drug Interaction Trial Among HIV Patients

    Details : Dolutegravir is a HIV type 1 integrase inhibitor, which is being evaluated in combination with daily rifapentine-moxifloxacin plus isoniazid and pyrazinamide regimen for HIV-associated tuberculosis.

    Brand Name : Tivicay

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    February 14, 2024

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    AHF Praises Colombia's Stand for Accessible HIV Treatment

    Details:

    Dolutegravir tablets is a HIV-1 integrase strand transfer inhibitor (INSTI) indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection.


    Lead Product(s): Dolutegravir Sodium

    Therapeutic Area: Infections and Infectious Diseases Brand Name: Tivicay-Generic

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: AIDS Healthcare Foundation

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable October 06, 2023

    blank

    05

    ViiV Healthcare

    United Kingdom
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    SupplySide West 2024
    Not Confirmed

    ViiV Healthcare

    United Kingdom
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    SupplySide West 2024
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

    Lead Product(s) : Dolutegravir Sodium

    Therapeutic Area : Infections and Infectious Diseases

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : AIDS Healthcare Foundation

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    AHF Praises Colombia's Stand for Accessible HIV Treatment

    Details : Dolutegravir tablets is a HIV-1 integrase strand transfer inhibitor (INSTI) indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection.

    Brand Name : Tivicay-Generic

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    October 06, 2023

    blank

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    Viatris Announces U.S. FDA Tentative Approval of a Paediatric Formulation of Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC), a Once-daily Treatment ...

    Details:

    The fixed-dose combination of abacavir 60 mg/dolutegravir 5 mg/lamivudine 30 mg tablets for oral suspension is indicated for the treatment of HIV-1 infection in paediatric patients weighing at least 6 kg.


    Lead Product(s): Abacavir,Dolutegravir Sodium,Lamivudine

    Therapeutic Area: Infections and Infectious Diseases Brand Name: Undisclosed

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable September 05, 2023

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    06

    Viatris

    U.S.A
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    SupplySide West 2024
    Not Confirmed

    Viatris

    U.S.A
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    SupplySide West 2024
    Not Confirmed
    • fda
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    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

    Lead Product(s) : Abacavir,Dolutegravir Sodium,Lamivudine

    Therapeutic Area : Infections and Infectious Diseases

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Viatris Announces U.S. FDA Tentative Approval of a Paediatric Formulation of Abacavir (ABC)/Dolute...

    Details : The fixed-dose combination of abacavir 60 mg/dolutegravir 5 mg/lamivudine 30 mg tablets for oral suspension is indicated for the treatment of HIV-1 infection in paediatric patients weighing at least 6 kg.

    Brand Name : Undisclosed

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    September 05, 2023

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    Lupin Gets US FDA Tentative Approval for Dolutegravir Tablets for Oral Suspension

    Details:

    Dolutegravir tablets is a HIV-1 integrase strand transfer inhibitor (INSTI) indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection.


    Lead Product(s): Dolutegravir Sodium

    Therapeutic Area: Infections and Infectious Diseases Brand Name: Tivicay-Generic

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable July 04, 2023

    blank

    07

    Lupin Ltd

    India
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    SupplySide West 2024
    Not Confirmed

    Lupin Ltd

    India
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    SupplySide West 2024
    Not Confirmed
    • fda
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    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

    Lead Product(s) : Dolutegravir Sodium

    Therapeutic Area : Infections and Infectious Diseases

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Lupin Gets US FDA Tentative Approval for Dolutegravir Tablets for Oral Suspension

    Details : Dolutegravir tablets is a HIV-1 integrase strand transfer inhibitor (INSTI) indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection.

    Brand Name : Tivicay-Generic

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    July 04, 2023

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    Lupin Receives Tentative Approval From U.S. FDA for Dolutegravir, Emtricitabine and Tenofovir Alafenamide (DETAF) Tablets

    Details:

    The combination inhibits HIV-1 replication, in which dolutegravir inhibits HIV integrase and blocks the strand transfer step of retroviral DNA integration where emtricitabine and tenofovir alafenamide inhibits the activity of the HIV-1 reverse transcriptase.


    Lead Product(s): Dolutegravir Sodium,Emtricitabine,Tenofovir Alafenamide

    Therapeutic Area: Infections and Infectious Diseases Brand Name: Dolutegravir/Emtricitabine/Tenofovir Alafenamide-Generic

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable January 31, 2023

    blank

    08

    Lupin Ltd

    India
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    SupplySide West 2024
    Not Confirmed

    Lupin Ltd

    India
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    SupplySide West 2024
    Not Confirmed
    • fda
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    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

    Lead Product(s) : Dolutegravir Sodium,Emtricitabine,Tenofovir Alafenamide

    Therapeutic Area : Infections and Infectious Diseases

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Lupin Receives Tentative Approval From U.S. FDA for Dolutegravir, Emtricitabine and Tenofovir Alaf...

    Details : The combination inhibits HIV-1 replication, in which dolutegravir inhibits HIV integrase and blocks the strand transfer step of retroviral DNA integration where emtricitabine and tenofovir alafenamide inhibits the activity of the HIV-1 reverse transcript...

    Brand Name : Dolutegravir/Emtricitabine/Tenofovir Alafenamide-Generic

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    January 31, 2023

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    Lupin Receives Tentative Approval from U.S. FDA for Dolutegravir and Rilpivirine Tablets

    Details:

    Dolutegravir Sodium, where dolutegravir is an integrase inhibitor while rilpivirine is a non-nucleoside reverse transcriptase inhibitor (NNRTI) which is used as an oral combination for the treatment of HIV-1 infections in treatment-naive patients.


    Lead Product(s): Dolutegravir Sodium,Rilpivirine Hydrochloride

    Therapeutic Area: Infections and Infectious Diseases Brand Name: Dolutegravir/Rilpivirine-Generic

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable January 16, 2023

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    09

    Lupin Ltd

    India
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    SupplySide West 2024
    Not Confirmed

    Lupin Ltd

    India
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    SupplySide West 2024
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

    Lead Product(s) : Dolutegravir Sodium,Rilpivirine Hydrochloride

    Therapeutic Area : Infections and Infectious Diseases

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Lupin Receives Tentative Approval from U.S. FDA for Dolutegravir and Rilpivirine Tablets

    Details : Dolutegravir Sodium, where dolutegravir is an integrase inhibitor while rilpivirine is a non-nucleoside reverse transcriptase inhibitor (NNRTI) which is used as an oral combination for the treatment of HIV-1 infections in treatment-naive patients.

    Brand Name : Dolutegravir/Rilpivirine-Generic

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    January 16, 2023

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    ViiV Healthcare to Present New Data From Innovative HIV treatment and Prevention Portfolio at AIDS 2022

    Details:

    Dovato (dolutegravir sodium), is indicated as a complete regimen to treat HIV-1 infection in adults with no antiretroviral (ARV) treatment history or to replace the current ARV regimen in those who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable ARV regimen.


    Lead Product(s): Dolutegravir Sodium,Lamivudine

    Therapeutic Area: Infections and Infectious Diseases Brand Name: Dovato

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable July 25, 2022

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    ViiV Healthcare

    United Kingdom
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    SupplySide West 2024
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    United Kingdom
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    Lead Product(s) : Dolutegravir Sodium,Lamivudine

    Therapeutic Area : Infections and Infectious Diseases

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    ViiV Healthcare to Present New Data From Innovative HIV treatment and Prevention Portfolio at AIDS...

    Details : Dovato (dolutegravir sodium), is indicated as a complete regimen to treat HIV-1 infection in adults with no antiretroviral (ARV) treatment history or to replace the current ARV regimen in those who are virologically suppressed (HIV-1 RNA <50 copies/mL) o...

    Brand Name : Dovato

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    July 25, 2022

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    INTERMEDIATES SUPPLIERS

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    01

    Faran Shimi Pharmaceutical

    Iran
    SupplySide West 2024
    Not Confirmed
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    Virtual BoothFaran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.

    2-(2-Hydroxyphenyl)-4H-1,3-benzoxazin-4-one

    CAS Number : 1218-69-5

    End Use API : Dolutegravir Sodium

    About The Company : Faran Shimi Pharmaceutical Company, established in 2001 and affiliated with Golrang Pharmaceutical Investment Co, manufactures high-quality Active Pharmaceutica...

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    Virupaksha Organics

    India
    CPhI India 2024
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    Virtual BoothWith Virupaksha, you get a quality product with on-time delivery.

    (R)-3-amino-1-butanol

    CAS Number : 61477-40-5

    End Use API : Dolutegravir Sodium

    About The Company : Virupaksha Organics, founded in 2003 by G. Chandra Mouliswar Reddy, is committed to delivering products of the utmost quality to its customers. In a span of les...

    Virupaksha

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    Jinan Tantu Chemicals

    China
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    Virtual BoothJinan Tantu Chemicals offers customized R&D services & production of small molecule APIs & pharmaceutical intermediates.

    1-(2,2-diMethoxyethyl)-5-Methoxy-6-(Methoxycarbony...

    CAS Number : 1335210-23-5

    End Use API : Dolutegravir Sodium

    About The Company : Jinan Tantu Chemicals Co., Ltd. operates as a Contract Development and Manufacturing Organization (CDMO) that serves pharmaceutical companies worldwide. Our cor...

    Jinan Tantu Chemicals

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    04

    Laxmi Organic Industries Ltd

    India
    CPhI India 2024
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    Virtual BoothLaxmi Organics is a prominent player with a record of building state-of-the-art assets to cater to the needs of a global customer base.

    Methyl 4-chloroacetoacetate

    CAS Number : 32807-28-6

    End Use API : Dolutegravir Sodium

    About The Company : "The Company’s product portfolio includes a wide range of products such as Acetyl Intermediates, Speciality Intermediates, and Fluorine Intermediates. These p... Since its inception, the company has maintained a constant focus on quality, innovation, sustainability, customer centricity which has enabled it to become a reliable partner for its customers." class="partyInfoTitle fa fa-info-circle" aria-hidden="true">

    Laxmi Organic

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    Laxmi Organic Industries Ltd

    India
    CPhI India 2024
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    Virtual BoothLaxmi Organics is a prominent player with a record of building state-of-the-art assets to cater to the needs of a global customer base.

    Methyl 4-methoxyacetoacetate

    CAS Number : 41051-15-4

    End Use API : Dolutegravir Sodium

    About The Company : "The Company’s product portfolio includes a wide range of products such as Acetyl Intermediates, Speciality Intermediates, and Fluorine Intermediates. These p... Since its inception, the company has maintained a constant focus on quality, innovation, sustainability, customer centricity which has enabled it to become a reliable partner for its customers." class="partyInfoTitle fa fa-info-circle" aria-hidden="true">

    Laxmi Organic

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    06

    Almelo

    India
    SupplySide West 2024
    Not Confirmed
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    Almelo

    India
    SupplySide West 2024
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    1-(2,2-Dimethoxyethyl)-5- Methoxy-6- (Methoxycarbo...

    CAS Number : CAS-1335210-23-5

    End Use API : Dolutegravir Sodium

    About The Company : Almelo are the industry leaders in manufacturing advanced intermediates, Active Pharmaceutical Ingredients (APIs) and specialty fine chemicals. With a diverse p...

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    Almelo

    India
    SupplySide West 2024
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    Almelo

    India
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    (4R,12aS)-7-Methoxy-4-Methyl- 6,8-Dioxo-3,4,6,8,12...

    CAS Number : CAS-1335210-34-8

    End Use API : Dolutegravir Sodium

    About The Company : Almelo are the industry leaders in manufacturing advanced intermediates, Active Pharmaceutical Ingredients (APIs) and specialty fine chemicals. With a diverse p...

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    08

    Anupam Rasayan India Ltd.

    India
    SupplySide West 2024
    Not Confirmed
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    Anupam Rasayan India Ltd.

    India
    SupplySide West 2024
    Not Confirmed
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    2,4-Difluorobenzylamine

    CAS Number : 72235-52-0

    End Use API : Dolutegravir Sodium

    About The Company : Anupam Rasayan India Limited was started in 1976 and we are 36 years old. ISO 9001:2008 and ISO 14001:2004 certified chemical company with sound technology, en...

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    09

    Beijing Mesochem Technology

    China
    SupplySide West 2024
    Not Confirmed
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    Beijing Mesochem Technology

    China
    SupplySide West 2024
    Not Confirmed
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    (4R,12aS)-3,4,6,8,12,12a-Hexahydro-7-hydroxy-4-met...

    CAS Number : CAS-1246616-73-8

    End Use API : Dolutegravir Sodium

    About The Company : Beijing Mesochem Technology Co. Ltd., which is located in the national economic and technological development area of Yizhuang, China, manufactures pharmaceutic...

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    10

    Guangdong Raffles PharmaTech Co Ltd

    China
    SupplySide West 2024
    Not Confirmed
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    Guangdong Raffles PharmaTech Co Ltd

    China
    SupplySide West 2024
    Not Confirmed
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    (4R,12aS)-N-(2,4-Difluorobenzyl)-7-methoxy-4-methy...

    CAS Number : 1335210-35-9

    End Use API : Dolutegravir Sodium

    About The Company : Established in August 2011, Raffles PharmaTech is a high-tech enterprise that focus on development, manufacturing and sales of high-value added active pharmaceu...

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    01

    Aspen Pharmacare Holdings

    South Africa
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    Regulatory Info : Generic

    Registration Country : South Africa

    Dolutegravir

    Brand Name : Gradovir

    Dosage Form : TAB

    Dosage Strength : 50mg

    Packaging : 30X1mg

    Approval Date :

    Application Number :

    Regulatory Info : Generic

    Registration Country : South Africa

    Aspen API Comapny Banner

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    02

    Aspen Pharmacare Holdings

    South Africa
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    Regulatory Info : Generic

    Registration Country : South Africa

    Dolutegravir

    Brand Name : Vulante

    Dosage Form : FCT

    Dosage Strength : 50mg

    Packaging : 30X1mg

    Approval Date :

    Application Number :

    Regulatory Info : Generic

    Registration Country : South Africa

    Aspen API Comapny Banner

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    03

    Strides Pharma Science

    India
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    Virtual BoothStrides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.

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    Regulatory Info :

    Registration Country : India

    Dolutegravir Sodium

    Brand Name :

    Dosage Form : Tablet

    Dosage Strength : 50MG

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : India

    Strides Pharma Science

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    Strides Pharma Science

    India
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    Virtual BoothStrides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.

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    Regulatory Info : Generic

    Registration Country : South Africa

    Dolutegravir

    Brand Name : Lendofil

    Dosage Form : FCT

    Dosage Strength : 50mg

    Packaging : 30X1mg

    Approval Date :

    Application Number :

    Regulatory Info : Generic

    Registration Country : South Africa

    Strides Pharma Science

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    05

    Aurobindo Pharma Limited

    India
    SupplySide West 2024
    Not Confirmed
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    Aurobindo Pharma Limited

    India
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    Regulatory Info :

    Registration Country : USA

    DOLUTEGRAVIR SODIUM

    Brand Name : DOLUTEGRAVIR SODIUM

    Dosage Form : TABLET;ORAL

    Dosage Strength : 50MG

    Packaging :

    Approval Date :

    Application Number : 208355

    Regulatory Info :

    Registration Country : USA

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    Cipla Medpro South Africa

    South Africa
    Saudi International Expo
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    Cipla Medpro South Africa

    South Africa
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    Regulatory Info : Originator

    Registration Country : South Africa

    Dolutegravir

    Brand Name : Telado

    Dosage Form : FCT

    Dosage Strength : 50mg

    Packaging : 30X1mg

    Approval Date :

    Application Number :

    Regulatory Info : Originator

    Registration Country : South Africa

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    Laurus Labs

    India
    Saudi International Expo
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    Laurus Labs

    India
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    Regulatory Info :

    Registration Country : USA

    DOLUTEGRAVIR; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE

    Brand Name : DOLUTEGRAVIR; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE

    Dosage Form : TABLET;ORAL

    Dosage Strength : 50MG; 300MG;300MG

    Packaging :

    Approval Date :

    Application Number : 210787

    Regulatory Info :

    Registration Country : USA

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    Laurus Labs

    India
    Saudi International Expo
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    Laurus Labs

    India
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    Regulatory Info :

    Registration Country : USA

    DOLUTEGRAVIR SODIUM

    Brand Name : DOLUTEGRAVIR SODIUM

    Dosage Form : TABLET; ORAL

    Dosage Strength : 50MG

    Packaging :

    Approval Date :

    Application Number : 210963

    Regulatory Info :

    Registration Country : USA

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    Viatris

    U.S.A
    Saudi International Expo
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    Viatris

    U.S.A
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    Regulatory Info : Originator

    Registration Country : South Africa

    Dolutegravir

    Brand Name : Odinsti Dispersible Tablets

    Dosage Form : ODT

    Dosage Strength : 10mg

    Packaging : 30X1mg

    Approval Date :

    Application Number :

    Regulatory Info : Originator

    Registration Country : South Africa

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    Viatris

    U.S.A
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    Regulatory Info : Generic

    Registration Country : South Africa

    Dolutegravir

    Brand Name : Kavideza

    Dosage Form : FCT

    Dosage Strength : 50mg

    Packaging : 30X1mg

    Approval Date :

    Application Number :

    Regulatory Info : Generic

    Registration Country : South Africa

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    01

    CIPLA USA INC.

    India
    SupplySide West 2024
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    CIPLA USA INC.

    India
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    RLD :

    TE Code :

    DOLUTEGRAVIR LAMIVUDINE TENOFOVIR ALAFENAMIDE

    Brand Name : DOLUTEGRAVIR LAMIVUDINE TENOFOVIR ALAFENAMIDE

    Dosage Form : TABLET

    Dosage Strength : EQ 50MG BASE; 300MG; 25MG

    Approval Date :

    Application Number : 212527

    RX/OTC/DISCN :

    RLD :

    TE Code :

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    LAURUS GENERICS INC

    Germany
    SupplySide West 2024
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    LAURUS GENERICS INC

    Germany
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    RLD :

    TE Code :

    DOLUTEGRAVIR

    Brand Name : DOLUTEGRAVIR

    Dosage Form : FILM;ORAL

    Dosage Strength : 5MG

    Approval Date :

    Application Number : 215319

    RX/OTC/DISCN :

    RLD :

    TE Code :

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    LAURUS LABS LTD

    India
    SupplySide West 2024
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    India
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    RLD :

    TE Code :

    DOLUTEGRAVIR; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE

    Brand Name : DOLUTEGRAVIR; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE

    Dosage Form : TABLET;ORAL

    Dosage Strength : 50MG; 300MG;300MG

    Approval Date :

    Application Number : 210787

    RX/OTC/DISCN :

    RLD :

    TE Code :

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    MACLEODS PHARMS LTD

    India
    SupplySide West 2024
    Not Confirmed
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    MACLEODS PHARMS LTD

    India
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    RLD :

    TE Code :

    DOLUTEGRAVIR; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE

    Brand Name : DOLUTEGRAVIR; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE

    Dosage Form : TABLET;ORAL

    Dosage Strength : 50MG/300MG/300MG

    Approval Date :

    Application Number : 210796

    RX/OTC/DISCN :

    RLD :

    TE Code :

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    MACLEODS PHARMS LTD

    India
    SupplySide West 2024
    Not Confirmed
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    MACLEODS PHARMS LTD

    India
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    RLD :

    TE Code :

    DOLUTEGRAVIR SODIUM

    Brand Name : DOLUTEGRAVIR SODIUM

    Dosage Form : TABLET; ORAL SUSPENSION

    Dosage Strength : 10MG

    Approval Date :

    Application Number : 214566

    RX/OTC/DISCN :

    RLD :

    TE Code :

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    06

    LUPIN PHARMS

    U.S.A
    SupplySide West 2024
    Not Confirmed
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    LUPIN PHARMS

    U.S.A
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    RLD :

    TE Code :

    DOLUTEGRAVIR; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE

    Brand Name : DOLUTEGRAVIR, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE

    Dosage Form : TABLET; ORAL

    Dosage Strength : 50MG/300MG/300MG

    Approval Date :

    Application Number : 212303

    RX/OTC/DISCN :

    RLD :

    TE Code :

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    07

    SHANGHAI DESANA BIO-PHARMACEUTICALS CO LTD

    China
    SupplySide West 2024
    Not Confirmed
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    SHANGHAI DESANA BIO-PHARMACEUTICALS CO LTD

    China
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    Not Confirmed
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    RLD :

    TE Code :

    DOLUTEGRAVIR; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE

    Brand Name : DOLUTEGRAVIR, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE

    Dosage Form : TABLET;ORAL

    Dosage Strength : 50MG; 300MG; 300MG

    Approval Date :

    Application Number : 213556

    RX/OTC/DISCN :

    RLD :

    TE Code :

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    08

    VIIV HLTHCARE

    United Kingdom
    SupplySide West 2024
    Not Confirmed
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    VIIV HLTHCARE

    United Kingdom
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    SupplySide West 2024
    Not Confirmed
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    RLD : Yes

    TE Code :

    DOLUTEGRAVIR SODIUM

    Brand Name : TIVICAY

    Dosage Form : TABLET;ORAL

    Dosage Strength : EQ 50MG BASE

    Approval Date : 2013-08-12

    Application Number : 204790

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code :

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    09

    VIIV HLTHCARE

    United Kingdom
    SupplySide West 2024
    Not Confirmed
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    VIIV HLTHCARE

    United Kingdom
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    SupplySide West 2024
    Not Confirmed
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    RLD : Yes

    TE Code :

    DOLUTEGRAVIR SODIUM

    Brand Name : TIVICAY

    Dosage Form : TABLET;ORAL

    Dosage Strength : EQ 10MG BASE

    Approval Date : 2016-06-09

    Application Number : 204790

    RX/OTC/DISCN : DISCN

    RLD : Yes

    TE Code :

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    10

    VIIV HLTHCARE

    United Kingdom
    SupplySide West 2024
    Not Confirmed
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    VIIV HLTHCARE

    United Kingdom
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    SupplySide West 2024
    Not Confirmed
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    RLD : Yes

    TE Code :

    DOLUTEGRAVIR SODIUM

    Brand Name : TIVICAY

    Dosage Form : TABLET;ORAL

    Dosage Strength : EQ 25MG BASE

    Approval Date : 2016-06-09

    Application Number : 204790

    RX/OTC/DISCN : DISCN

    RLD : Yes

    TE Code :

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    Europe

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    01

    ViiV Healthcare UK Ltd

    United Kingdom
    SupplySide West 2024
    Not Confirmed
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    ViiV Healthcare UK Ltd

    United Kingdom
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    Regulatory Info :

    Registration Country : Sweden

    dolutegravirnatrium

    Brand Name : Tivicay

    Dosage Form : FILM COATED PILL

    Dosage Strength : 50 MG

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Sweden

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    02

    VIIV HEALTHCARE UK LTD

    United Kingdom
    SupplySide West 2024
    Not Confirmed
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    VIIV HEALTHCARE UK LTD

    United Kingdom
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    Not Confirmed
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    Regulatory Info :

    Registration Country : Italy

    Dolutegravir

    Brand Name : Tivicay

    Dosage Form : Dolutegravir 50Mg 30 Joined' Oral Use

    Dosage Strength : 30 cpr riv 50 mg

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Italy

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    03

    VIIV HEALTHCARE UK LTD

    United Kingdom
    SupplySide West 2024
    Not Confirmed
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    VIIV HEALTHCARE UK LTD

    United Kingdom
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    SupplySide West 2024
    Not Confirmed
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    Regulatory Info :

    Registration Country : Italy

    Dolutegravir; Abacavir; Lamivudine

    Brand Name : Triumeq

    Dosage Form : Dolutegravir+Abacavir+Lamivudine 50+600+300Mg 30 Joined' Oral Use

    Dosage Strength : 30 cpr riv 50 mg + 600mg + 300mg bottle

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Italy

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    04

    ViiV Healthcare UK Ltd.

    United Kingdom
    SupplySide West 2024
    Not Confirmed
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    ViiV Healthcare UK Ltd.

    United Kingdom
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    SupplySide West 2024
    Not Confirmed
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    Regulatory Info :

    Registration Country : Norway

    Dolutegravir

    Brand Name : Tivicay

    Dosage Form : Antic-calc Tablet, Film Coated

    Dosage Strength : 50 mg

    Packaging : Box of plastic

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Norway

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    05

    ViiV Healthcare UK Ltd.

    United Kingdom
    SupplySide West 2024
    Not Confirmed
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    ViiV Healthcare UK Ltd.

    United Kingdom
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    Not Confirmed
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    Regulatory Info :

    Registration Country : Norway

    Lamivudine; Abacavir; Dolutegravir

    Brand Name : Triumeq

    Dosage Form : Antic-calc Tablet, Film Coated

    Dosage Strength :

    Packaging : Box

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Norway

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    06

    ViiV Healthcare GmbH

    United Kingdom
    SupplySide West 2024
    Not Confirmed
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    ViiV Healthcare GmbH

    United Kingdom
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    SupplySide West 2024
    Not Confirmed
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    Regulatory Info :

    Registration Country : Switzerland

    Dolutegravir; Rilpivirinum

    Brand Name : Juluca

    Dosage Form : Filmtablet

    Dosage Strength : 50/25mg

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Switzerland

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    07

    ViiV Healthcare GmbH

    United Kingdom
    SupplySide West 2024
    Not Confirmed
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    ViiV Healthcare GmbH

    United Kingdom
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    Regulatory Info :

    Registration Country : Switzerland

    Dolutegravirum

    Brand Name : Tivicay

    Dosage Form : Filmtabl

    Dosage Strength : 50mg

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Switzerland

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    08

    ViiV Healthcare GmbH

    United Kingdom
    SupplySide West 2024
    Not Confirmed
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    ViiV Healthcare GmbH

    United Kingdom
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    Regulatory Info :

    Registration Country : Switzerland

    Dolutegravirum; Abacavirum; Lamivudinum

    Brand Name : Triumeq

    Dosage Form : Filmtabl

    Dosage Strength :

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Switzerland

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    09

    ViiV Healthcare GmbH

    United Kingdom
    SupplySide West 2024
    Not Confirmed
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    ViiV Healthcare GmbH

    United Kingdom
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    Regulatory Info :

    Registration Country : Switzerland

    Dolutegravirum; Lamivudinum

    Brand Name : Dovato

    Dosage Form : Filmtabl

    Dosage Strength : 50/300mg

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Switzerland

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    10

    ViiV Healthcare GmbH

    United Kingdom
    SupplySide West 2024
    Not Confirmed
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    ViiV Healthcare GmbH

    United Kingdom
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    Regulatory Info :

    Registration Country : Switzerland

    Dolutegravirum; Lamivudinum

    Brand Name : Dovato

    Dosage Form : Filmtabl

    Dosage Strength : 50/300mg

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Switzerland

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    DRUG PRODUCT COMPOSITIONS

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    DOSAGE - TABLET;ORAL - EQ 10MG BASE

    USFDA APPLICATION NUMBER - 204790

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    DOSAGE - TABLET;ORAL - EQ 25MG BASE

    USFDA APPLICATION NUMBER - 204790

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    DOSAGE - TABLET;ORAL - EQ 50MG BASE

    USFDA APPLICATION NUMBER - 204790

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    DOSAGE - TABLET;ORAL - EQ 600MG BASE;EQ 50MG ...DOSAGE - TABLET;ORAL - EQ 600MG BASE;EQ 50MG BASE;300MG

    USFDA APPLICATION NUMBER - 205551

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