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1. Gs-ca1
1. Gs-6207
2. 2189684-44-2
3. Gs-hiv
4. Gs-ca2
5. Gs-ca-2
6. Lenacapavir [usan]
7. Gs-ca1
8. A9a0o6fb4h
9. Gs-714207
10. Gs6207
11. N-[(1s)-1-[3-[4-chloro-3-(methanesulfonamido)-1-(2,2,2-trifluoroethyl)indazol-7-yl]-6-(3-methyl-3-methylsulfonylbut-1-ynyl)pyridin-2-yl]-2-(3,5-difluorophenyl)ethyl]-2-[(2s,4r)-5,5-difluoro-9-(trifluoromethyl)-7,8-diazatricyclo[4.3.0.02,4]nona-1(6),8-dien-7-yl]acetamide
12. N-((s)-1-(3-(4-chloro-3-(methylsulfonamido)-1-(2,2,2-trifluoroethyl)-1h-indazol-7-yl)-6-(3-methyl-3-(methylsulfonyl)but-1-yn-1-yl)pyridin-2-yl)-2-(3,5-difluorophenyl)ethyl)-2-((3bs,4ar)-5,5-difluoro-3-(trifluoromethyl)-3b,4,4a,5-tetrahydro-1h-cyclopropa[3,4]cyclopenta[1,2-c]pyrazol-1-yl)acetamide
13. N-[(1s)-1-(3-{4-chloro-3-[(methylsulfonyl)amino]-1-(2,2,2-trifluoroethyl)-1h-indazol-7-yl}-6-[3-methyl-3-(methylsulfonyl)but-1-yn-1-yl]pyridin-2-yl)-2-(3,5-difluorophenyl)ethyl]-2-[(3bs,4ar)-5,5-difluoro-3-(trifluoromethyl)-3b,4,4a,5-tetrahydro-1h-cyclopropa[3,4]cyclopenta[1,2-c]pyrazol-1-yl]acetamide
14. Qng
15. Lenacapavir [inn]
16. Unii-a9a0o6fb4h
17. Lenacapavir [who-dd]
18. Chembl4594438
19. Schembl19875642
20. Gtpl11446
21. Ex-a5518
22. Who 11108
23. At20076
24. Hy-111964
25. Cs-0094695
26. 1h-cyclopropa(3,4)cyclopenta(1,2-c)pyrazole, N-((1s)-1-(3-(4-chloro-3-((methylsulfonyl)amino)-1-(2,2,2-trifluoroethyl)-1h-indazol-7-yl)-6-(3-methyl-3-(methylsulfonyl)-1-butyn-1-yl)-2-pyridinyl)-2-(3,5-difluorophenyl)ethyl)-5,5-difluoro-3b,4,4a,5-tetrahydro-3-(trifluoromethyl)-, (3bs,4ar)-
27. N-((1s)-1-(3-(4-chloro-3-(methanesulfonamido)-1-(2,2,2-trifluoroethyl)-1h-indazol-7-yl)-6-(3-(methanesulfonyl)-3-methylbut-1-yn-1-yl)pyridin-2-yl)-2-(3,5- Difluorophenyl)ethyl)-2-((3bs,4ar)-5,5-difluoro-3-(trifluoromethyl)-3b,4,4a,5-tetrahydro-1h-cyclopropa(3,4)cyclopenta(1,2-c)pyrazol-1-yl)acetamide
28. N-[(1s)-1-[3-[4-chloro-3-(methanesulfonamido)-1-(2,2,2-trifluoroethyl)indazol-7-yl]-6-(3-methyl-3-methylsulfonyl-but-1-ynyl)-2-pyridyl]-2-(3,5-difluorophenyl)ethyl]-2-[difluoro(trifluoromethyl)[?]yl]acetamide
Molecular Weight | 968.3 g/mol |
---|---|
Molecular Formula | C39H32ClF10N7O5S2 |
XLogP3 | 6.4 |
Hydrogen Bond Donor Count | 2 |
Hydrogen Bond Acceptor Count | 19 |
Rotatable Bond Count | 13 |
Exact Mass | 967.1435188 g/mol |
Monoisotopic Mass | 967.1435188 g/mol |
Topological Polar Surface Area | 175 Ų |
Heavy Atom Count | 64 |
Formal Charge | 0 |
Complexity | 2040 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 3 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 1 |
Treatment of human immunodeficiency virus (HIV-1) infection
* Sunlenca injection: , in combination with other antiretroviral(s), is indicated for the treatment of adults with multidrug resistant HIV 1 infection for whom it is otherwise not possible to construct a suppressive anti viral regimen (see sections 4. 2 and 5. 1).
* Sunlenca tablet: , in combination with other antiretroviral(s), is indicated for the treatment of adults with multidrug resistant HIV 1 infection for whom it is otherwise not possible to construct a suppressive anti viral regimen, for oral loading prior to administration of long-acting lenacapavir injection (see sections 4. 2 and 5. 1).
J05AX
J - Antiinfectives for systemic use
J05 - Antivirals for systemic use
J05A - Direct acting antivirals
J05AX - Other antivirals
J05AX31 - Lenacapavir
NDC Package Code : 54014-6902
Start Marketing Date : 2022-12-22
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 66721-830
Start Marketing Date : 2022-08-17
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (20kg/20kg)
Marketing Category : BULK INGREDIENT
Details:
MK-8591 (islatravir) is a non-nucleoside reverse transcriptase translocation inhibitor, which is being investigated in phase 2 for HIV-1 infection, in combination with lenacapavir.
Lead Product(s): Islatravir,Lenacapavir
Therapeutic Area: Infections and Infectious Diseases Brand Name: MK-8591
Study Phase: Phase IIProduct Type: Small molecule
Sponsor: Merck & Co
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 21, 2024
Lead Product(s) : Islatravir,Lenacapavir
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Merck & Co
Deal Size : Not Applicable
Deal Type : Not Applicable
Merck-Gilead Oral Combo Suppresses HIV for 48 Weeks, Preps for Pivotal Program
Details : MK-8591 (islatravir) is a non-nucleoside reverse transcriptase translocation inhibitor, which is being investigated in phase 2 for HIV-1 infection, in combination with lenacapavir.
Brand Name : MK-8591
Molecule Type : Small molecule
Upfront Cash : Not Applicable
October 21, 2024
Details:
The agreement aims to make and sell generic lenacapavir, subject to required regulatory approvals, in 120 high-incidence, resource-limited countries for HIV prevention.
Lead Product(s): Lenacapavir
Therapeutic Area: Infections and Infectious Diseases Brand Name: Sunlenca
Study Phase: Phase IIIProduct Type: Small molecule
Sponsor: Viatris
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement October 02, 2024
Lead Product(s) : Lenacapavir
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Viatris
Deal Size : Undisclosed
Deal Type : Licensing Agreement
Gilead Partners with Six Generics For Lenacapavir Access in HIV Prevention
Details : The agreement aims to make and sell generic lenacapavir, subject to required regulatory approvals, in 120 high-incidence, resource-limited countries for HIV prevention.
Brand Name : Sunlenca
Molecule Type : Small molecule
Upfront Cash : Undisclosed
October 02, 2024
Details:
The agreement aims to make and sell generic lenacapavir, subject to required regulatory approvals, in 120 high-incidence, resource-limited countries for HIV prevention.
Lead Product(s): Lenacapavir
Therapeutic Area: Infections and Infectious Diseases Brand Name: Sunlenca
Study Phase: Phase IIIProduct Type: Small molecule
Sponsor: Hetero
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement October 02, 2024
Lead Product(s) : Lenacapavir
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Hetero
Deal Size : Undisclosed
Deal Type : Licensing Agreement
Hetero Partners with Gilead To Expand HIV Drug Lenacapavir Access Globally
Details : The agreement aims to make and sell generic lenacapavir, subject to required regulatory approvals, in 120 high-incidence, resource-limited countries for HIV prevention.
Brand Name : Sunlenca
Molecule Type : Small molecule
Upfront Cash : Undisclosed
October 02, 2024
Details:
The agreement aims to make and sell generic lenacapavir, subject to required regulatory approvals, in 120 high-incidence, resource-limited countries for HIV prevention.
Lead Product(s): Lenacapavir
Therapeutic Area: Infections and Infectious Diseases Brand Name: Sunlenca
Study Phase: Phase IIIProduct Type: Small molecule
Sponsor: Dr. Reddy\'s Laboratories
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement October 02, 2024
Lead Product(s) : Lenacapavir
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Dr. Reddy\'s Laboratories
Deal Size : Undisclosed
Deal Type : Licensing Agreement
Dr. Reddy’s Partners with Gilead to Manufacture Lenacapavir in India and Beyond
Details : The agreement aims to make and sell generic lenacapavir, subject to required regulatory approvals, in 120 high-incidence, resource-limited countries for HIV prevention.
Brand Name : Sunlenca
Molecule Type : Small molecule
Upfront Cash : Undisclosed
October 02, 2024
Details:
The agreement aims to make and sell generic lenacapavir, subject to required regulatory approvals, in 120 high-incidence, resource-limited countries for HIV prevention.
Lead Product(s): Lenacapavir
Therapeutic Area: Infections and Infectious Diseases Brand Name: Sunlenca
Study Phase: Phase IIIProduct Type: Small molecule
Sponsor: Emcure Pharmaceuticals
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement October 02, 2024
Lead Product(s) : Lenacapavir
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Emcure Pharmaceuticals
Deal Size : Undisclosed
Deal Type : Licensing Agreement
Gilead Partners with Six Generic Makers to Expand HIV Prevention Access Globally
Details : The agreement aims to make and sell generic lenacapavir, subject to required regulatory approvals, in 120 high-incidence, resource-limited countries for HIV prevention.
Brand Name : Sunlenca
Molecule Type : Small molecule
Upfront Cash : Undisclosed
October 02, 2024
Details:
The agreement aims to make and sell generic lenacapavir, subject to required regulatory approvals, in 120 high-incidence, resource-limited countries for HIV prevention.
Lead Product(s): Lenacapavir
Therapeutic Area: Infections and Infectious Diseases Brand Name: Sunlenca
Study Phase: Phase IIIProduct Type: Small molecule
Sponsor: Eva Pharma
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement October 02, 2024
Lead Product(s) : Lenacapavir
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Eva Pharma
Deal Size : Undisclosed
Deal Type : Licensing Agreement
Gilead Partners with Six Generic Makers to Expand HIV Prevention Access Globally
Details : The agreement aims to make and sell generic lenacapavir, subject to required regulatory approvals, in 120 high-incidence, resource-limited countries for HIV prevention.
Brand Name : Sunlenca
Molecule Type : Small molecule
Upfront Cash : Undisclosed
October 02, 2024
Details:
The agreement aims to make and sell generic lenacapavir, subject to required regulatory approvals, in 120 high-incidence, resource-limited countries for HIV prevention.
Lead Product(s): Lenacapavir
Therapeutic Area: Infections and Infectious Diseases Brand Name: Sunlenca
Study Phase: Phase IIIProduct Type: Small molecule
Sponsor: Ferozsons Laboratories
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement October 02, 2024
Lead Product(s) : Lenacapavir
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Ferozsons Laboratories
Deal Size : Undisclosed
Deal Type : Licensing Agreement
Gilead Partners with Six Generic Makers to Expand HIV Prevention Access Globally
Details : The agreement aims to make and sell generic lenacapavir, subject to required regulatory approvals, in 120 high-incidence, resource-limited countries for HIV prevention.
Brand Name : Sunlenca
Molecule Type : Small molecule
Upfront Cash : Undisclosed
October 02, 2024
Details:
MK-8591 (islatravir) is a non-nucleoside reverse transcriptase translocation inhibitor, which is being investigated in phase 2 for HIV-1 infection, in combination with lenacapavir.
Lead Product(s): Islatravir,Lenacapavir
Therapeutic Area: Infections and Infectious Diseases Brand Name: MK-8591
Study Phase: Phase IIProduct Type: Small molecule
Sponsor: Merck & Co
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 06, 2024
Lead Product(s) : Islatravir,Lenacapavir
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Merck & Co
Deal Size : Not Applicable
Deal Type : Not Applicable
Gilead and Merck Announce Phase 2 Data for Islatravir and Lenacapavir Combination Regimen
Details : MK-8591 (islatravir) is a non-nucleoside reverse transcriptase translocation inhibitor, which is being investigated in phase 2 for HIV-1 infection, in combination with lenacapavir.
Brand Name : MK-8591
Molecule Type : Small molecule
Upfront Cash : Not Applicable
March 06, 2024
Details:
GS-9883 (bictegravir), an HIV type 1 integrase inhibitor in combination with GS-6207 (lenacapavir), a structural capsid protein inhibitor is being evaluated for the treatment of HIV-1-infection.
Lead Product(s): Bictegravir,Lenacapavir
Therapeutic Area: Infections and Infectious Diseases Brand Name: GS-9883
Study Phase: Phase II/ Phase IIIProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 05, 2024
Lead Product(s) : Bictegravir,Lenacapavir
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase II/ Phase III
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Gilead’s Innovative HIV Research Pipeline Aims to Address Unmet Needs and Advance Health
Details : GS-9883 (bictegravir), an HIV type 1 integrase inhibitor in combination with GS-6207 (lenacapavir), a structural capsid protein inhibitor is being evaluated for the treatment of HIV-1-infection.
Brand Name : GS-9883
Molecule Type : Small molecule
Upfront Cash : Not Applicable
March 05, 2024
Details:
Sunlenca (lenacapavir) is a selective long-acting inhibitor of HIV-1 capsid function which inhibits HIV-1 replication by interfering with multiple essential steps of the viral lifecycle.
Lead Product(s): Lenacapavir
Therapeutic Area: Infections and Infectious Diseases Brand Name: Sunlenca
Study Phase: Phase IIProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 18, 2023
Lead Product(s) : Lenacapavir
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : Sunlenca (lenacapavir) is a selective long-acting inhibitor of HIV-1 capsid function which inhibits HIV-1 replication by interfering with multiple essential steps of the viral lifecycle.
Brand Name : Sunlenca
Molecule Type : Small molecule
Upfront Cash : Not Applicable
October 18, 2023
2-((3bS,4aR)-5,5-Difluoro-3-(trifluoromethyl)-3b,4...
CAS Number : 1620056-83-8
End Use API : Lenacapavir
About The Company : Headquartered in Fengxian District, Shanghai Minbiotech Co., Ltd. is a company specializing in the R&D and production of advanced pharmaceutical intermediate...
3-Methyl-3-(methylsulfonyl)but-1-yne
CAS Number : 2109226-54-0
End Use API : Lenacapavir
About The Company : Headquartered in Fengxian District, Shanghai Minbiotech Co., Ltd. is a company specializing in the R&D and production of advanced pharmaceutical intermediate...
tert-butylN-[(1S)-1-(3,6-dibromopyridin-2-yl)-2-(3...
CAS Number : 1620056-47-4
End Use API : Lenacapavir
About The Company : Headquartered in Fengxian District, Shanghai Minbiotech Co., Ltd. is a company specializing in the R&D and production of advanced pharmaceutical intermediate...
Carbamic acid, N-[(1S)-1-[3-bromo-6-[3-methyl-3-(...
CAS Number : 2189684-54-4
End Use API : Lenacapavir
About The Company : Headquartered in Fengxian District, Shanghai Minbiotech Co., Ltd. is a company specializing in the R&D and production of advanced pharmaceutical intermediate...
4-Chloro-7-(4,4,5,5-tetramethyl-1,3,2-dioxaborolan...
CAS Number : 2189684-53-3
End Use API : Lenacapavir
About The Company : Headquartered in Fengxian District, Shanghai Minbiotech Co., Ltd. is a company specializing in the R&D and production of advanced pharmaceutical intermediate...
2-((3bS,4aR)-5,5-difluoro-3- (trifluoromethyl)-3b,...
CAS Number : 1620056-83-8
End Use API : Lenacapavir
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 & ope...
CAS Number : 91-00-9
End Use API : Lenacapavir
About The Company : SCI Pharmtech Inc. offers APIs, advanced intermediates, and custom products, focusing on quick development and cost-effective production. Our research labs, pil...
CAS Number : 91-00-9
End Use API : Lenacapavir
About The Company : SCI Pharmtech Inc. offers APIs, advanced intermediates, and custom products, focusing on quick development and cost-effective production. Our research labs, pil...
4-Chloro-7-(4,4,5,5-tetramethyl-1,3,2-dioxaborolan...
CAS Number : 2189684-53-3
End Use API : Lenacapavir
About The Company : Saptagir Laboratories Private incorporated in 2016, is a manufacturer and supplier of Active Pharmaceutical Ingredients (APIs) and Intermediates for a wide rang...
Tert-butyl (S)-[1-(3-bromo-6-[3-methyl-3-(methyl s...
CAS Number : 2189684-54-4
End Use API : Lenacapavir
About The Company : Saptagir Laboratories Private incorporated in 2016, is a manufacturer and supplier of Active Pharmaceutical Ingredients (APIs) and Intermediates for a wide rang...
Regulatory Info : RX
Registration Country : USA
Brand Name : SUNLENCA
Dosage Form : SOLUTION;SUBCUTANEOUS
Dosage Strength : EQ 463.5MG BASE/1.5ML (EQ 309MG BASE/ML)
Packaging :
Approval Date : 2022-12-22
Application Number : 215973
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : SUNLENCA
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 300MG BASE
Packaging :
Approval Date : 2022-12-22
Application Number : 215974
Regulatory Info : RX
Registration Country : USA
RLD : Yes
TE Code :
Brand Name : SUNLENCA
Dosage Form : SOLUTION;SUBCUTANEOUS
Dosage Strength : EQ 463.5MG BASE/1.5ML (EQ 309MG BASE/ML)
Approval Date : 2022-12-22
Application Number : 215973
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Brand Name : SUNLENCA
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 300MG BASE
Approval Date : 2022-12-22
Application Number : 215974
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
Patents & EXCLUSIVITIES
Patent Expiration Date : 2034-02-28
US Patent Number : 9951043
Drug Substance Claim : Y
Drug Product Claim : Y
Application Number : 215973
Patent Use Code : U-3507
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2034-02-28
Patent Expiration Date : 2034-02-28
US Patent Number : 9951043
Drug Substance Claim : Y
Drug Product Claim : Y
Application Number : 215974
Patent Use Code : U-3507
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2034-02-28
Patent Expiration Date : 2037-08-17
US Patent Number : 10654827
Drug Substance Claim :
Drug Product Claim :
Application Number : 215974
Patent Use Code : U-3507
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2037-08-17
Patent Expiration Date : 2038-08-16
US Patent Number : 11267799
Drug Substance Claim : Y
Drug Product Claim :
Application Number : 215974
Patent Use Code :
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2038-08-16
Patent Expiration Date : 2037-08-17
US Patent Number : 10071985
Drug Substance Claim : Y
Drug Product Claim : Y
Application Number : 215973
Patent Use Code :
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2037-08-17
Patent Expiration Date : 2041-06-04
US Patent Number : 11944611
Drug Substance Claim : Y
Drug Product Claim : Y
Application Number : 215974
Patent Use Code : U-3507
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2041-06-04
Patent Expiration Date : 2037-08-17
US Patent Number : 10071985
Drug Substance Claim : Y
Drug Product Claim : Y
Application Number : 215974
Patent Use Code :
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2037-08-17
Patent Expiration Date : 2041-06-04
US Patent Number : 11944611
Drug Substance Claim :
Drug Product Claim :
Application Number : 215973
Patent Use Code : U-3507
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2041-06-04
Patent Expiration Date : 2038-08-16
US Patent Number : 11267799
Drug Substance Claim : Y
Drug Product Claim :
Application Number : 215973
Patent Use Code :
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2038-08-16
Patent Expiration Date : 2037-08-17
US Patent Number : 10654827
Drug Substance Claim :
Drug Product Claim :
Application Number : 215973
Patent Use Code : U-3507
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2037-08-17
Exclusivity Code : NCE
Exclusivity Expiration Date : 2027-12-22
Application Number : 215974
Product Number : 1
Exclusivity Details :
Exclusivity Code : NCE
Exclusivity Expiration Date : 2027-12-22
Application Number : 215973
Product Number : 1
Exclusivity Details :
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