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    Chemistry

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    Also known as: Methylphenidan, Phenidylate, Calocain, Plimasine, 113-45-1, Concerta
    Molecular Formula
    C14H19NO2
    Molecular Weight
    233.31  g/mol
    InChI Key
    DUGOZIWVEXMGBE-UHFFFAOYSA-N
    Methylphenidate
    A central nervous system stimulant used most commonly in the treatment of ATTENTION DEFICIT DISORDER in children and for NARCOLEPSY. Its mechanisms appear to be similar to those of DEXTROAMPHETAMINE. The d-isomer of this drug is referred to as DEXMETHYLPHENIDATE HYDROCHLORIDE.
    1 2D Structure

    Methylphenidate

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    methyl 2-phenyl-2-piperidin-2-ylacetate
    2.1.2 InChI
    InChI=1S/C14H19NO2/c1-17-14(16)13(11-7-3-2-4-8-11)12-9-5-6-10-15-12/h2-4,7-8,12-13,15H,5-6,9-10H2,1H3
    2.1.3 InChI Key
    DUGOZIWVEXMGBE-UHFFFAOYSA-N
    2.1.4 Canonical SMILES
    COC(=O)C(C1CCCCN1)C2=CC=CC=C2
    2.2 Synonyms
    2.2.1 MeSH Synonyms

    1. Centedrin

    2. Concerta

    3. Daytrana

    4. Equasym

    5. Hydrochloride, Methylphenidate

    6. Metadate

    7. Methylin

    8. Methylphenidate Hydrochloride

    9. Phenidylate

    10. Ritalin

    11. Ritalin Sr

    12. Ritalin-sr

    13. Ritaline

    14. Tsentedrin

    2.2.2 Depositor-Supplied Synonyms

    1. Methylphenidan

    2. Phenidylate

    3. Calocain

    4. Plimasine

    5. 113-45-1

    6. Concerta

    7. Methyl Phenidylacetate

    8. Methyl Phenidate

    9. Metilfenidato [italian]

    10. Methylphenidatum

    11. Metilfenidato [inn-spanish]

    12. Methylphenidatum [inn-latin]

    13. 4311/b Ciba

    14. Methyl Phenidyl Acetate

    15. Methyl Phenyl(piperidin-2-yl)acetate

    16. Methylin

    17. Methyl Alpha-phenyl-alpha-(2-piperidyl)acetate

    18. Alpha-phenyl-2-piperidineacetic Acid Methyl Ester

    19. Daytrana

    20. Methylphenidate Hcl

    21. Nci-c56280

    22. 2-piperidineacetic Acid, Alpha-phenyl-, Methyl Ester

    23. Methyl Alpha-phenyl-alpha-2-piperidinylacetate

    24. Chembl796

    25. 2-piperidineacetic Acid, .alpha.-phenyl-, Methyl Ester

    26. Methyl 2-phenyl-2-(piperidin-2-yl)acetate

    27. Methylfenidan

    28. Chebi:84276

    29. Metilfenidato

    30. Methylphenidylacetate Hydrochloride

    31. .alpha.-phenyl-2-piperidineacetic Acid Methyl Ester

    32. D-methylphenidate Hcl

    33. Cotempla Xr-odt

    34. Daytrana (tn)

    35. Threo-dl-methylphenidate

    36. Methyl 2-phenyl-2-piperidin-2-ylacetate

    37. Hsdb 3126

    38. Methyl (2-phenyl-2-(2-piperidyl)acetate)

    39. Prc-063

    40. Einecs 204-028-6

    41. C 4311

    42. Methylphenidate Extended Release

    43. Methylphenidate (usan/inn)

    44. Rubifen

    45. Alpha-phenyl-alpha-(2-piperidyl)acetic Acid Methyl Ester

    46. Dea No. 1724

    47. Methylphenidate [usan:inn:ban]

    48. 40572-71-2

    49. Ritalin (salt/mix)

    50. Methylin (salt/mix)

    51. Ritaline (salt/mix)

    52. Centedein (salt/mix)

    53. Centedrin (salt/mix)

    54. Centedrine (salt/mix)

    55. Schembl37178

    56. Gtpl7236

    57. Dtxsid5023299

    58. Jornay Pm (a.k.a. Hld200)

    59. Bcp18286

    60. Hy-b1091

    61. Bdbm50062912

    62. Methyl Alpha-piperid-2-ylphenylacetate

    63. Methyl Phenyl(2-piperidinyl)acetate #

    64. Cs-4657

    65. Db00422

    66. Ncgc00248587-01

    67. Ncgc00248587-03

    68. Methyl .alpha.-phenyl-2-piperidineacetate

    69. Sbi-0206868.p001

    70. Methyl .alpha.-phenyl-2-piperidine-acetate

    71. C07196

    72. D04999

    73. Phenyl-piperidin-2-yl-acetic Acid Methyl Ester

    74. Ab01563134_01

    75. 2-piperidineacetic Acid, ?-phenyl-, Methyl Ester

    76. L001307

    77. Q422112

    78. Methyl .alpha.-phenyl-.alpha.-(2-piperidyl)acetate

    79. Methyl .alpha.-phenyl-.alpha.-2-piperidinylacetate

    80. (s,2s)--phenyl-2-piperidineacetic Acid Methyl Ester

    81. Brd-a19585813-003-01-7

    2.3 Create Date
    2005-03-25
    3 Chemical and Physical Properties
    Molecular Weight 233.31 g/mol
    Molecular Formula C14H19NO2
    XLogP30.2
    Hydrogen Bond Donor Count1
    Hydrogen Bond Acceptor Count3
    Rotatable Bond Count4
    Exact Mass233.141578849 g/mol
    Monoisotopic Mass233.141578849 g/mol
    Topological Polar Surface Area38.3 Ų
    Heavy Atom Count17
    Formal Charge0
    Complexity249
    Isotope Atom Count0
    Defined Atom Stereocenter Count0
    Undefined Atom Stereocenter Count2
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count1
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 20  
    Drug NameConcerta
    PubMed HealthMethylphenidate
    Drug ClassesCNS Stimulant, Central Nervous System Agent
    Drug LabelCONCERTA is a central nervous system (CNS) stimulant. CONCERTA is available in four tablet strengths. Each extended-release tablet for once-a-day oral administration contains 18, 27, 36, or 54 mg of methylphenidate HCl USP and is designed to have...
    Active IngredientMethylphenidate hydrochloride
    Dosage FormTablet, extended release
    RouteOral
    Strength54mg; 18mg; 27mg; 36mg
    Market StatusPrescription
    CompanyJanssen Pharms

    2 of 20  
    Drug NameDaytrana
    PubMed HealthMethylphenidate
    Drug ClassesCNS Stimulant, Central Nervous System Agent
    Drug LabelDaytrana is an adhesive-based matrix transdermal system (patch) that is applied to intact skin. The chemical name for methylphenidate is -phenyl-2-piperidineacetic acid methyl ester. It is a white to off-white powder and is soluble in alcohol, ethy...
    Active IngredientMethylphenidate
    Dosage FormFilm, extended release
    RouteTransdermal
    Strength30mg/9hr (3.3mg/hr); 15mg/9hr (1.6mg/hr); 10mg/9hr (1.1mg/hr); 20mg/9hr (2.2mg/hr)
    Market StatusPrescription
    CompanyNoven Pharms

    3 of 20  
    Drug NameMetadate cd
    PubMed HealthMethylphenidate
    Drug ClassesCNS Stimulant, Central Nervous System Agent
    Drug LabelMETADATE CD is a central nervous system (CNS) stimulant. The extended-release capsules comprise both immediate-release (IR) and extended-release (ER) beads such that 30% of the dose is provided by the IR component and 70% of the dose is provided by t...
    Active IngredientMethylphenidate hydrochloride
    Dosage FormCapsule, extended release
    RouteOral
    Strength30mg; 50mg; 60mg; 10mg; 40mg; 20mg
    Market StatusPrescription
    CompanyUcb

    4 of 20  
    Drug NameMetadate er
    PubMed HealthMethylphenidate (By mouth)
    Drug ClassesCNS Stimulant, Central Nervous System Agent
    Drug LabelMETADATE ER Tablets (methylphenidate hydrochloride extended-release tablets, USP) are a mild central nervous system (CNS) stimulant. METADATE ER is available as 20 mg extended-release tablets for oral administration.Methylphenidate hydrochloride is m...
    Active IngredientMethylphenidate hydrochloride
    Dosage FormTablet, extended release
    RouteOral
    Strength20mg
    Market StatusPrescription
    CompanyUcb

    5 of 20  
    Drug NameMethylin
    PubMed HealthMethylphenidate
    Drug ClassesCNS Stimulant, Central Nervous System Agent
    Drug LabelMethylphenidate hydrochloride is a mild central nervous system (CNS) stimulant, available for oral administration as tablets of 5 mg, 10 mg, and 20 mg and as extended-release tablets of 10 mg and 20 mg. Methylphenidate hydrochloride is methyl -phen...
    Active IngredientMethylphenidate hydrochloride
    Dosage FormTablet, chewable; Solution
    RouteOral
    Strength2.5mg; 10mg/5ml; 5mg; 10mg; 5mg/5ml
    Market StatusPrescription
    CompanyMallinckrodt

    6 of 20  
    Drug NameMethylin er
    Drug LabelMethylphenidate hydrochloride is a mild central nervous system (CNS) stimulant, available for oral administration as tablets of 5 mg, 10 mg, and 20 mg and as extended-release tablets of 10 mg and 20 mg. Methylphenidate hydrochloride is methyl -phen...
    Active IngredientMethylphenidate hydrochloride
    Dosage FormTablet, extended release
    RouteOral
    Strength10mg; 20mg
    Market StatusPrescription
    CompanyMallinckrodt

    7 of 20  
    Drug NameQuillivant xr
    Drug LabelQUILLIVANT XR is a powder that, after reconstitution with water, forms an extended-release oral suspension formulation of methylphenidate intended for once daily oral administration. QUILLIVANT XR contains approximately 20% immediate-release and 80%...
    Active IngredientMethylphenidate hydrochloride
    Dosage FormFor suspension, extended release
    RouteOral
    Strength5mg/ml
    Market StatusPrescription
    CompanyNextwave Pharms

    8 of 20  
    Drug NameRitalin
    Drug LabelRitalin hydrochloride, methylphenidate hydrochloride USP, is a mild central nervous system (CNS) stimulant, available as tablets of 5, 10, and 20 mg for oral administration; Ritalin-SR is available as sustained-release tablets of 20 mg for oral admin...
    Active IngredientMethylphenidate hydrochloride
    Dosage FormTablet
    RouteOral
    Strength5mg; 10mg; 20mg
    Market StatusPrescription
    CompanyNovartis

    9 of 20  
    Drug NameRitalin la
    Drug LabelMethylphenidate hydrochloride is a central nervous system (CNS) stimulant. Ritalin LA (methylphenidate hydrochloride) extended-release capsules is an extended-release formulation of methylphenidate with a bi-modal release profile. Ritalin LA uses t...
    Active IngredientMethylphenidate hydrochloride
    Dosage FormCapsule, extended release
    RouteOral
    Strength30mg; 10mg; 40mg; 20mg
    Market StatusPrescription
    CompanyNovartis

    10 of 20  
    Drug NameRitalin-sr
    Active IngredientMethylphenidate hydrochloride
    Dosage FormTablet, extended release
    RouteOral
    Strength20mg
    Market StatusPrescription
    CompanyNovartis

    11 of 20  
    Drug NameConcerta
    PubMed HealthMethylphenidate
    Drug ClassesCNS Stimulant, Central Nervous System Agent
    Drug LabelCONCERTA is a central nervous system (CNS) stimulant. CONCERTA is available in four tablet strengths. Each extended-release tablet for once-a-day oral administration contains 18, 27, 36, or 54 mg of methylphenidate HCl USP and is designed to have...
    Active IngredientMethylphenidate hydrochloride
    Dosage FormTablet, extended release
    RouteOral
    Strength54mg; 18mg; 27mg; 36mg
    Market StatusPrescription
    CompanyJanssen Pharms

    12 of 20  
    Drug NameDaytrana
    PubMed HealthMethylphenidate
    Drug ClassesCNS Stimulant, Central Nervous System Agent
    Drug LabelDaytrana is an adhesive-based matrix transdermal system (patch) that is applied to intact skin. The chemical name for methylphenidate is -phenyl-2-piperidineacetic acid methyl ester. It is a white to off-white powder and is soluble in alcohol, ethy...
    Active IngredientMethylphenidate
    Dosage FormFilm, extended release
    RouteTransdermal
    Strength30mg/9hr (3.3mg/hr); 15mg/9hr (1.6mg/hr); 10mg/9hr (1.1mg/hr); 20mg/9hr (2.2mg/hr)
    Market StatusPrescription
    CompanyNoven Pharms

    13 of 20  
    Drug NameMetadate cd
    PubMed HealthMethylphenidate
    Drug ClassesCNS Stimulant, Central Nervous System Agent
    Drug LabelMETADATE CD is a central nervous system (CNS) stimulant. The extended-release capsules comprise both immediate-release (IR) and extended-release (ER) beads such that 30% of the dose is provided by the IR component and 70% of the dose is provided by t...
    Active IngredientMethylphenidate hydrochloride
    Dosage FormCapsule, extended release
    RouteOral
    Strength30mg; 50mg; 60mg; 10mg; 40mg; 20mg
    Market StatusPrescription
    CompanyUcb

    14 of 20  
    Drug NameMetadate er
    PubMed HealthMethylphenidate (By mouth)
    Drug ClassesCNS Stimulant, Central Nervous System Agent
    Drug LabelMETADATE ER Tablets (methylphenidate hydrochloride extended-release tablets, USP) are a mild central nervous system (CNS) stimulant. METADATE ER is available as 20 mg extended-release tablets for oral administration.Methylphenidate hydrochloride is m...
    Active IngredientMethylphenidate hydrochloride
    Dosage FormTablet, extended release
    RouteOral
    Strength20mg
    Market StatusPrescription
    CompanyUcb

    15 of 20  
    Drug NameMethylin
    PubMed HealthMethylphenidate
    Drug ClassesCNS Stimulant, Central Nervous System Agent
    Drug LabelMethylphenidate hydrochloride is a mild central nervous system (CNS) stimulant, available for oral administration as tablets of 5 mg, 10 mg, and 20 mg and as extended-release tablets of 10 mg and 20 mg. Methylphenidate hydrochloride is methyl -phen...
    Active IngredientMethylphenidate hydrochloride
    Dosage FormTablet, chewable; Solution
    RouteOral
    Strength2.5mg; 10mg/5ml; 5mg; 10mg; 5mg/5ml
    Market StatusPrescription
    CompanyMallinckrodt

    16 of 20  
    Drug NameMethylin er
    Drug LabelMethylphenidate hydrochloride is a mild central nervous system (CNS) stimulant, available for oral administration as tablets of 5 mg, 10 mg, and 20 mg and as extended-release tablets of 10 mg and 20 mg. Methylphenidate hydrochloride is methyl -phen...
    Active IngredientMethylphenidate hydrochloride
    Dosage FormTablet, extended release
    RouteOral
    Strength10mg; 20mg
    Market StatusPrescription
    CompanyMallinckrodt

    17 of 20  
    Drug NameQuillivant xr
    Drug LabelQUILLIVANT XR is a powder that, after reconstitution with water, forms an extended-release oral suspension formulation of methylphenidate intended for once daily oral administration. QUILLIVANT XR contains approximately 20% immediate-release and 80%...
    Active IngredientMethylphenidate hydrochloride
    Dosage FormFor suspension, extended release
    RouteOral
    Strength5mg/ml
    Market StatusPrescription
    CompanyNextwave Pharms

    18 of 20  
    Drug NameRitalin
    Drug LabelRitalin hydrochloride, methylphenidate hydrochloride USP, is a mild central nervous system (CNS) stimulant, available as tablets of 5, 10, and 20 mg for oral administration; Ritalin-SR is available as sustained-release tablets of 20 mg for oral admin...
    Active IngredientMethylphenidate hydrochloride
    Dosage FormTablet
    RouteOral
    Strength5mg; 10mg; 20mg
    Market StatusPrescription
    CompanyNovartis

    19 of 20  
    Drug NameRitalin la
    Drug LabelMethylphenidate hydrochloride is a central nervous system (CNS) stimulant. Ritalin LA (methylphenidate hydrochloride) extended-release capsules is an extended-release formulation of methylphenidate with a bi-modal release profile. Ritalin LA uses t...
    Active IngredientMethylphenidate hydrochloride
    Dosage FormCapsule, extended release
    RouteOral
    Strength30mg; 10mg; 40mg; 20mg
    Market StatusPrescription
    CompanyNovartis

    20 of 20  
    Drug NameRitalin-sr
    Active IngredientMethylphenidate hydrochloride
    Dosage FormTablet, extended release
    RouteOral
    Strength20mg
    Market StatusPrescription
    CompanyNovartis

    4.2 Therapeutic Uses

    Central Nervous System Stimulants; Dopamine Uptake Inhibitors

    National Library of Medicine's Medical Subject Headings. Methylphenidate. Online file (MeSH, 2015). Available from, as of November 20, 2015: https://www.nlm.nih.gov/mesh/2015/mesh_browser/MBrowser.html

    /CLINICAL TRIALS/ ClinicalTrials.gov is a registry and results database of publicly and privately supported clinical studies of human participants conducted around the world. The Web site is maintained by the National Library of Medicine (NLM) and the National Institutes of Health (NIH). Each ClinicalTrials.gov record presents summary information about a study protocol and includes the following: Disease or condition; Intervention (for example, the medical product, behavior, or procedure being studied); Title, description, and design of the study; Requirements for participation (eligibility criteria); Locations where the study is being conducted; Contact information for the study locations; and Links to relevant information on other health Web sites, such as NLM's MedlinePlus for patient health information and PubMed for citations and abstracts for scholarly articles in the field of medicine. Methylphenidate is included in the database.

    NIH/NLM; ClinicalTrials.Gov. Available from, as of September 30, 2015: https://clinicaltrials.gov/search/intervention=methylphenidate

    MEDICATION (VET): Methylphenidate may be useful for diagnosing and treating cataplexy/narcolepsy or hyperactivity in dogs.

    Plumb D.C. Veterinary Drug Handbook. 8th ed. (pocket). Ames, IA: Wiley-Blackwell, 2015., p. 957

    Treatment of cocaine abuse with agonists such as methylphenidate has been attempted, but with litle success except in patients with attention deficit disorders.

    DHHS/NIDA; Research Monograph Series 88: Mechanisms of Cocaine Abuse and Toxicity p.125 (1988) DHHS Pub No. (ADM)89-1585

    For more Therapeutic Uses (Complete) data for METHYLPHENIDATE (7 total), please visit the HSDB record page.

    4.3 Drug Warning

    Methylphenidate should be used with caution in patients with hypertension. Blood pressure should be monitored at appropriate intervals in patients receiving the drug, especially those with hypertension.

    American Society of Health-System Pharmacists 2015; Drug Information 2015. Bethesda, MD. 2015, p. 2552

    Hypersensitivity reactions including rash, macular rash, urticaria, fever, arthralgia, exfoliative dermatitis, erythema multiforme with histopathologic findings of necrotizing vasculitis, and thrombocytopenic purpura may occur in patients receiving methylphenidate. Stevens-Johnson syndrome has been reported rarely. Fixed drug eruption, angioedema, anaphylactic reaction, auricular swelling, bullous conditions, pruritus, eruptions, and exanthemas have been reported in patients receiving methylphenidate, although a definite causal relationship has not been established. Erythema occurs in a majority of patients receiving methylphenidate as the transdermal system but generally causes minimal or no discomfort.

    American Society of Health-System Pharmacists 2015; Drug Information 2015. Bethesda, MD. 2015, p. 2551

    Abnormal liver function, ranging from serum aminotransferase (transaminase) elevations to hepatic coma, has been reported in patients receiving methylphenidate, although a definite causal relationship has not been established. Hepatotoxicity was associated with methylphenidate therapy in at least one patient.

    American Society of Health-System Pharmacists 2015; Drug Information 2015. Bethesda, MD. 2015, p. 2551

    The most frequent adverse effects of methylphenidate appear to be dose related and include nervousness and insomnia.

    American Society of Health-System Pharmacists 2015; Drug Information 2015. Bethesda, MD. 2015, p. 2551

    For more Drug Warnings (Complete) data for METHYLPHENIDATE (23 total), please visit the HSDB record page.

    4.4 Drug Indication

    Methylphenidate is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years of age and older and for the treatment of narcolepsy.

    5 Pharmacology and Biochemistry
    5.1 Pharmacology

    Methylphenidate is a racemic mixture comprised of the d- and l-isomers. The d-isomer is more pharmacologically active than the l-isomer. Radioligand binding studies demonstrate that binding of methylphenidate in the brain is localized to dopamine-rich areas, in particular in the prefrontal cortex which has been demonstrated to play a prominent role in ADHD pathophysiology. In a number of animal models, methylphenidate enhances locomotor activity and induces stereotypic behaviours.

    5.2 MeSH Pharmacological Classification

    Central Nervous System Stimulants

    A loosely defined group of drugs that tend to increase behavioral alertness, agitation, or excitation. They work by a variety of mechanisms, but usually not by direct excitation of neurons. The many drugs that have such actions as side effects to their main therapeutic use are not included here. (See all compounds classified as Central Nervous System Stimulants.)

    Dopamine Uptake Inhibitors

    Drugs that block the transport of DOPAMINE into axon terminals or into storage vesicles within terminals. Most of the ADRENERGIC UPTAKE INHIBITORS also inhibit dopamine uptake. (See all compounds classified as Dopamine Uptake Inhibitors.)

    5.3 FDA Pharmacological Classification
    5.3.1 Pharmacological Classes
    Central Nervous System Stimulation [PE]; Central Nervous System Stimulant [EPC]
    5.4 ATC Code

    N06BA04

    S76 | LUXPHARMA | Pharmaceuticals Marketed in Luxembourg | Pharmaceuticals marketed in Luxembourg, as published by d'Gesondheetskeess (CNS, la caisse nationale de sante, www.cns.lu), mapped by name to structures using CompTox by R. Singh et al. (in prep.). List downloaded from https://cns.public.lu/en/legislations/textes-coordonnes/liste-med-comm.html. Dataset DOI:10.5281/zenodo.4587355

    N - Nervous system

    N06 - Psychoanaleptics

    N06B - Psychostimulants, agents used for adhd and nootropics

    N06BA - Centrally acting sympathomimetics

    N06BA04 - Methylphenidate

    5.5 Absorption, Distribution and Excretion

    Absorption

    Concerta: Methylphenidate is readily absorbed. Following oral administration of Concerta, plasma methylhphenidate concentrations reach an initial maximum at about 1 hour followed by gradual ascending concentrations over the next 5-9 hours. Mean times to reach peak plasma concentrations across all doses of Concerta occurred between 6-10 hours. Once daily dosing minimizes the fluctuations between peak and trough concentrations associated with multiple doses of immediate-release methylphenidate treatments. Depending on the doses provided, Cmax was found to range from 6.0-15.0ng/mL, Tmax ranged from 8.1-9.4h, and AUC ranged from 50.4-121.5 ngh/mL in children. When provided as Concerta, methylphenidate is released through the patented Osmotic Controlled-Release Oral Delivery (OROS) system where 22% of the dose is provided as an immediate release and 78% is provided through a gradual release. OROS is comprised of an osmotically active trilayer core surrounded by a semipermeable membrane with an immediate-release drug overcoat. Within an aqueous environment, such as the stomach, the drug overcoat, which consists of 22% of the dose, dissolves within one hour, providing an initial immediate-release formulation of methylphenidate. Water then permeates through the membrane into the tablet core where the osmotically active polymer excipients expand, allowing methylphenidate to release slowly through the orifice over a period of 6-7 hours. Concerta also provides a sustained 10-12 hour effect, allowing for once-daily dosing. Biphentin: Methylphenidate is rapidly and extensively absorbed following oral administration, with peak blood levels obtained in 1-3 hours. When provided as Biphentin, methylphenidate is released through a multi-layer release delivery system (MLRTM) where 40% of the dose is provided as an immediate release and 60% is provided through a gradual release. Biphentin was designed to be an alternative to separate doses of immediate-release (IR) methylphenidate by providing a biphasic concentration-time profile when given as a single dose. The MLRTM release system allows for a sustained effect for 10-12 hours, allowing for once-daily dosing that covers the major times that ADHD impairment might occur (such as school, homework periods, during the workday, etc). Methylphenidate (immediate release): Methylphenidate hydrochloride is rapidly and extensively absorbed from the tablets following oral administration; however, owing to extensive first-pass metabolism, bioavailability is low (approx. 30%) and large individual differences exist (11-52%). In one study, the administration of methylphenidate hydrochloride with food accelerated absorption but had no effect on the amount absorbed. Peak plasma concentrations of 10.8 and 7.8 ng/mL were observed, on average, 2 hours after administration of 0.30 mg/kg in children and adults, respectively. Peak plasma concentrations showed marked variability between subjects. Both the area under the concentration-time curve (AUC), and the peak plasma concentrations (Cmax) showed dose-proportionality.

    Route of Elimination

    After oral administration of an immediate release formulation of methylphenidate, 78%-97% of the dose is excreted in the urine and 1%-3% in the feces in the form of metabolites within 48-96 hours. Only small quantities (<1%) of unchanged methylphenidate appear in the urine. Most of the dose is excreted in the urine as ritalinic acid (60%-86%), the remainder being accounted for by minor metabolites.

    Volume of Distribution

    Concerta: Plasma methylphenidate concentrations in adults decline bi-exponentially following oral administration. Biphentin: The apparent distribution volume of methylphenidate in children is approximately 20 L/kg, with substantial variability (11 to 33 L/kg). Methylphenidate (immediate release): The apparent distribution volume of methylphenidate in children was approximately 20 L/kg, with substantial variability (11-33 L/kg). The volume of distribution after an intravenous dose (Vss) is 2.23 L/kg for the racemate in healthy adult volunteers.

    Clearance

    The apparent mean systemic clearance after an oral dose is 10.2 and 10.5 L/h/kg in children and adults, respectively for a 0.3 mg/kg dose, and 0.565 L/h/kg after an intravenous dose of the racemate in healthy adult volunteers.

    Methylphenidate HCl Oral Solution is readily absorbed. Following oral administration of Methylphenidate HCl Oral Solution, peak plasma methylphenidate concentrations are achieved at 1 to 2 hours.

    NIH; DailyMed. Current Medication Information for METHYLPHENIDATE HCL ORAL SOLUTION- methylphenidate hydrochloride solution (Revised: May 2015). Available from, as of November 24, 2015: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7b372d74-7ba7-437a-be8c-6e8335b78818

    Methylphenidate is readily absorbed after oral administration and reaches peak concentrations in plasma in about 2 hr.

    Brunton, L. Chabner, B, Knollman, B. Goodman and Gillman's The Pharmaceutical Basis of Therapeutics, Twelth Edition, McGraw Hill Medical, New York, NY. 2011, p. 299

    Men received 0.15 or 0.3 mg/kg of methylphenidate orally, and methylphenidate and ritalinic acid, a metabolite, were analyzed in plasma samples obtained at various times after treatment. Maximal methylphenidate concentrations in plasma were found to occur 2.2 hours after administration of either dose. The mean maximal concentration in plasma for methylphenidate was 3.5 ng/mL after 0.15 mg/kg, and 7.8 ng/mL after 0.3 mg/kg. Methylphenidate clearances were high (10.1 L/hour/kg) and variable (range: 3.6-23.2) for the 0.3 mg/kg dose. Pharmacokinetic parameters for children receiving 0.3 mg/kg were essentially the same as for the adults. Ritalinic acid plasma levels were 50-100 times greater than methylphenidate levels in normal adults. The clearance of ritalinic acid is less than that of methylphenidate. When admin to the rat, the absolute bioavailability of methylphenidate was found to be 0.19 in the rat and 0.22 in the monkey, suggesting substantial presystemic elimination of methylphenidate.

    PMID:6410043 WARGIN W ET AL; J PHARMACOL EXP THER 226 (2): 382-6 (1983)

    Neuroanatomical distribution of (14)C-labeled methylphenidate was examined in rabbit brain following intracerebroventricular administration at 15, 60, and 180 minutes after the injection. The highest levels were observed at the 1st sampling time (15 minutes) in medulla and cervical spinal cord. The pons, caudate, tegmentum, and hypothalamus also showed significant uptake of (14)C-methylphenidate.

    SHAH NS ET AL; PROG NEURO-PSYCHOPHARMACOL BIOL PSYCHIATRY 7 (1): 101-6 (1983)

    For more Absorption, Distribution and Excretion (Complete) data for METHYLPHENIDATE (7 total), please visit the HSDB record page.

    5.6 Metabolism/Metabolites

    Methylphenidate is hepatically metabolized. More specifically, it is rapidly and extensively metabolized by carboxylesterase CES1A1. Via this enzyme, methylphenidate undergoes de-esterification to ritalinic acid (a-phenyl-2-piperidine acetic acid, PPAA), which has little to no pharmacologic activity.

    In humans, methylphenidate is metabolized primarily via deesterification to alpha-phenylpiperidine acetic acid (PPA, ritalinic acid). The metabolite has little or no pharmacologic activity.

    NIH; DailyMed. Current Medication Information for METHYLPHENIDATE HCL ORAL SOLUTION- methylphenidate hydrochloride solution (Revised: May 2015). Available from, as of November 24, 2015: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7b372d74-7ba7-437a-be8c-6e8335b78818

    5.7 Biological Half-Life

    Concerta: The half-life of methylphenidate in adults following oral administration of Concerta was approximately 3.5 h. Biphentin: Methylphenidate is eliminated from plasma with a mean half-life of 2.4 hours in children and 2.1 hours in adults. Methylphenidate (immediate release): Methylphenidate is eliminated from the plasma with a mean half-life of 2.4 hours in children and 2.1 hours in adults.

    Methylphenidate ... is a racemate; /in plasma/ its more potent (+) enantimoer has a t(1/2) of approximately 6 hr, and the less potent (-) enantiomer has a t(1/2) of approximately 4 hr. Concentrations in the brain exceed those in plasma.

    Brunton, L. Chabner, B, Knollman, B. Goodman and Gillman's The Pharmaceutical Basis of Therapeutics, Twelth Edition, McGraw Hill Medical, New York, NY. 2011, p. 299

    The mean terminal half-life (t1/2) of methylphenidate following administration of 20 mg Methylphenidate HCl Oral Solution (t1/2 = 2.7 hours) is comparable to the mean terminal t1/2 following administration of Ritalin (methylphenidate hydrochloride immediate-release tablets) (t1/2 = 2.8h) in healthy adult volunteers.

    NIH; DailyMed. Current Medication Information for METHYLPHENIDATE HCL ORAL SOLUTION- methylphenidate hydrochloride solution (Revised: May 2015). Available from, as of November 24, 2015: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7b372d74-7ba7-437a-be8c-6e8335b78818

    5.8 Mechanism of Action

    While its exact mechanism is unclear, methylphenidate (MPH) has been shown to act as a norepinephrine and dopamine reuptake inhibitor (NDRI), thereby increasing the presence of these neurotransmitters in the extraneuronal space and prolonging their action. There is a dose-related effect of psychostimulants on receptor stimulation, where higher doses are shown to increase norepinephrine (NE) and dopamine (DA) efflux throughout the brain which can result in impaired cognition and locomotor-activating effects. In contrast, low doses are found to selectively activate NE and DE neurotransmission within the prefrontal cortex which is an area of the brain thought to play a prominent role in ADHD pathophysiology, thereby improving clinical efficacy and preventing side effects. The lower doses used to treat ADHD are not associated with the locomotor-activating effects associated with higher doses and instead reduce movement, impulsivity, and increase cognitive function including sustained attention and working memory. Methylphenidate's beneficial effects in sustaining attention have also been shown to be mediated by alpha-1 adrenergic receptor activity. Clinical findings have shown that children with ADHD have an abnormality in the dopamine transporter gene (DAT1), the D4 receptor gene (DRD-4), and/or the D2 receptor gene that may be at least partly overcome by the dopaminergic effects of methylphenidate, suggesting a possible mode of action.

    Methylphenidate is thought to block the reuptake of norepinephrine and dopamine into the presynaptic neuron and increase the release of these monoamines into the extraneuronal space.

    NIH; DailyMed. Current Medication Information for METHYLPHENIDATE HCL ORAL SOLUTION- methylphenidate hydrochloride solution (Revised: May 2015). Available from, as of November 24, 2015: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7b372d74-7ba7-437a-be8c-6e8335b78818

    Although the primary mechanism is largely unknown, the effects of methylphenidate appear to be mediated by blockage of the reuptake mechanism of dopaminergic neurons. In children with attention deficit disorder, methylphenidate decreases motor restlessness and enhances the ability to pay attention. In narcolepsy, methylphenidate appears to act at the cerebral cortex and subcortical structures, including the thalamus, to produce CNS stimulation, resulting in increaed motor activity, increased mental alertness, diminished sense of fatigue, brighter spirits, and mild euphoria.

    USP Convention. USPDI - Drug Information for the Health Care Professional. 17th ed. Volume I. Rockville, MD: Convention, Inc., 1997. (Plus Updates)., p. 2010

    Mode of action: Appears to exert most or all of its effect in the CNS by causing release of biogenic amines, especially norepinephrine and dopamine, from storage sites in nerve terminals. It may also slow down catecholamine metabolism by inhibiting monoamine oxidase.

    International Programme on Chemical Safety; Poisons Information Monograph: Methylphenidate Hydrochloride (PIM 344) (1998) Available from, as of October 24, 2005: https://www.inchem.org/pages/pims.html

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    Medlab Asia & Asia Health
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    Mallinckrodt Pharmaceuticals

    Ireland
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    Methylphenidate

    About the Company : Mallinckrodt Pharmaceuticals is a multibillion dollar specialty biopharmaceutical company focused on our mission: Managing Complexity. Improving Lives. We provide medicines to addr...

    Mallinckrodt Pharmaceuticals is a multibillion dollar specialty biopharmaceutical company focused on our mission: Managing Complexity. Improving Lives. We provide medicines to address unmet patient needs, steming from nearly 150 years of using our unique strengths, experience and expertise to help improve people’s lives. Discover how our rich history of innovation and patient-centered solutions has helped influence our vision for the future. Our strong ability to master and manage complexity is the key component in making high-quality products that provide value for patients.
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    Pellets Pharma Limited

    India
    Medlab Asia & Asia Health
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    Pellets Pharma Limited

    India
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    Methylphenidate

    About the Company : Pellets Pharma Limited is a fast growing organization established by a team of professionals with over decades of experience in the pharmaceutical industry with specific reference ...

    Pellets Pharma Limited is a fast growing organization established by a team of professionals with over decades of experience in the pharmaceutical industry with specific reference to the development and manufacture of various modified release solid oral dosage forms. The company’s forte is the customized development and manufacturing of Modified Release Pellets / Retard Micro Granules of various Active Pharmaceutical Ingredients (APIs) including different combination blends in Ready - To - Fill form. The facility is designed to meet the regulatory requirements inline with the cGMP norms.
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    06

    RA CHEM PHARMA LIMITED

    India
    Medlab Asia & Asia Health
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    RA CHEM PHARMA LIMITED

    India
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    Methylphenidate

    About the Company : RA Chem Pharma Limited is a vertically integrated pharmaceutical company.Over the past 10 years, it has expanded its spectrum by establishing state-of-the-art manufacturing facilit...

    RA Chem Pharma Limited is a vertically integrated pharmaceutical company.Over the past 10 years, it has expanded its spectrum by establishing state-of-the-art manufacturing facilities in API, Formulations and Clinical Research. RA Group consists of: cGMP compliant API manufacturing facility located in Jaggayapet, Krishna District in Andhra Pradesh, India. cGMP compliant solid dosage formulation manufacturing facility at Nacharam, Hyderabad, India. GCP and GLP compliant Clinical Research & Biosciences division at Balanagar, Hyderabad, India
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IN2400000512 DT.29.09.2024 ACTIVE PHARMA INGREDIENTS DEXMETHYLPHENIDATE (DXM)","address":"Plot No. 26 & 27, Technocrat Industrial Estate (TIE)","city":"Hyderabad","supplier":"COHANCE LIFESCIENCES","supplierCountry":"INDIA","foreign_port":"BASLE","customer":"TO","customerCountry":"SWITZERLAND","quantity":"2.00","actualQuantity":"2","unit":"KGS","unitRateFc":"6500.3","totalValueFC":"12841.8","currency":"USD","unitRateINR":538078.19999999995,"date":"30-Sep-2024","totalValueINR":"1076156.4","totalValueInUsd":"12841.8","indian_port":"Bombay Air","hs_no":"29333990","bill_no":"4468399","productDescription":"API","marketType":"REGULATED MARKET","country":"SWITZERLAND","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"Plot No. 26 & 27, Technocrat Industrial Estate (TIE), Hyderabad","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1729535400,"product":"SAP CODE : 2021240 HARMLESS PHARMACEUTICAL BULK DRUG: METHYLPHENIDATE HCL","address":"ACME PLAZA, ANDHERI KURLA ROAD,","city":"MUMBAI, MAHARASHTRA.","supplier":"SUN PHARMACEUTICAL INDUSTRIES LIMITED","supplierCountry":"INDIA","foreign_port":"TORONTO","customer":"M\/S.","customerCountry":"CANADA","quantity":"300.00","actualQuantity":"300","unit":"KGS","unitRateFc":"550","totalValueFC":"160811.7","currency":"USD","unitRateINR":45041.513333333336,"date":"22-Oct-2024","totalValueINR":"13512454","totalValueInUsd":"160811.7","indian_port":"Bombay Air","hs_no":"29333323","bill_no":"5034149","productDescription":"API","marketType":"REGULATED MARKET","country":"CANADA","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"ACME PLAZA, ANDHERI KURLA ROAD,, MUMBAI, MAHARASHTRA.","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1729708200,"product":"METHYLPHENIDATE HCL USP (EXP.AUTH.NO.P-EXP-15401\/2024 DT.19.09.2024.IMP.AUTH.NO.FP.03.04.SPIP\/IV\/297\/24 DT.2","address":"107A,VINAY BHAVYA COMPLEX","city":"MUMBAI ,MAHARASHTRA","supplier":"HARMAN FINOCHEM","supplierCountry":"INDIA","foreign_port":"JAKARTA","customer":"PT.MERSIFARMA TIRMAKU MERCUSANA","customerCountry":"INDONESIA","quantity":"40.00","actualQuantity":"40","unit":"KGS","unitRateFc":"805","totalValueFC":"31527","currency":"USD","unitRateINR":66227.676999999996,"date":"24-Oct-2024","totalValueINR":"2649107.08","totalValueInUsd":"31527","indian_port":"Bombay Air","hs_no":"29333323","bill_no":"5087563","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"INDONESIA","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"107A,VINAY BHAVYA COMPLEX, MUMBAI ,MAHARASHTRA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1730226600,"product":"GST INV.NO. IN2400000645 DT. 30.10.2024ACTIVE PHARMA INGREDIENT METHYLPHENIDATE HCL EP","address":"Plot No. 26 & 27, Technocrat Industrial Estate (TIE)","city":"Hyderabad","supplier":"COHANCE LIFESCIENCES","supplierCountry":"INDIA","foreign_port":"MADRID","customer":"TO","customerCountry":"SPAIN","quantity":"500.00","actualQuantity":"500","unit":"KGS","unitRateFc":"595","totalValueFC":"289336.8","currency":"USD","unitRateINR":48623.946000000004,"date":"30-Oct-2024","totalValueINR":"24311973","totalValueInUsd":"289336.8","indian_port":"Bombay Air","hs_no":"29333323","bill_no":"5295108","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"Plot No. 26 & 27, Technocrat Industrial Estate (TIE), Hyderabad","customerAddress":""},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1721759400,"product":"METHYLPHENIDATE HCL","address":"564\/A\/22, ROAD NO.92","city":"HYDERABAD,ANDHRA PRADESH","supplier":"CURIA MISSOURI,INC","supplierCountry":"UNITED STATES","foreign_port":"NEWARK, NJ","customer":"VIATRIS","customerCountry":"INDIA","quantity":"10.05","actualQuantity":"10.05","unit":"KGS","unitRateFc":"1650","totalValueFC":"16961.4","currency":"USD","unitRateINR":"141077","date":"24-Jul-2024","totalValueINR":"1417823.44","totalValueInUsd":"16961.4","indian_port":"Hyderabad Air","hs_no":"29333990","bill_no":"4657084","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"NEWARK, NJ","supplierAddress":"2460 W. BENNETT STREET SPRINGFIELDMO. 65807SDNF United States","customerAddress":"564\/A\/22, ROAD NO.92"}]
    27-Jan-2021
    30-Oct-2024
    KGS
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    Average Price (USD/KGS)

    Number of Transactions

    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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    Aytu BioPharma Announces Approval of the Cotempla XR-ODT(R) Manufacturing Site Transfer Prior Approval Supplement

    Details:

    Cotempla XR-ODT (methylphenidate extended-release orally disintegrating tablets) is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 17 years of age.


    Lead Product(s): Methylphenidate

    Therapeutic Area: Psychiatry/Psychology Brand Name: Cotempla

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable October 26, 2023

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    Aytu BioPharma

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    Lead Product(s) : Methylphenidate

    Therapeutic Area : Psychiatry/Psychology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Aytu BioPharma Announces Approval of the Cotempla XR-ODT(R) Manufacturing Site Transfer Prior Appr...

    Details : Cotempla XR-ODT (methylphenidate extended-release orally disintegrating tablets) is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 17 years of age.

    Brand Name : Cotempla

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    October 26, 2023

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    KemPharm Doses First Subject in Phase 1 Clinical Trial Evaluating Cardiovascular Safety of Serdexmethylphenidate (SDX)

    Details:

    Prodrug of d-methylphenidate, is sole API in KP1077, a potential first-ever therapeutic treatment for Idiopathic Hypersomnia, a neurological disorder marked by significant, detrimental effects on nighttime sleep as well as daytime sleepiness/wakefulness.


    Lead Product(s): Methylphenidate

    Therapeutic Area: Sleep Brand Name: KP1077

    Study Phase: Phase IProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable April 19, 2022

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    KemPharm

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    Lead Product(s) : Methylphenidate

    Therapeutic Area : Sleep

    Highest Development Status : Phase I

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    KemPharm Doses First Subject in Phase 1 Clinical Trial Evaluating Cardiovascular Safety of Serdexm...

    Details : Prodrug of d-methylphenidate, is sole API in KP1077, a potential first-ever therapeutic treatment for Idiopathic Hypersomnia, a neurological disorder marked by significant, detrimental effects on nighttime sleep as well as daytime sleepiness/wakefulness.

    Brand Name : KP1077

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    April 19, 2022

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    Aytu BioScience and Neos Therapeutics Announce Definitive Merger Agreement

    Details:

    Aytu adds Neos' established, multi-brand ADHD portfolio which includes Adzenys XR-ODT and Cotempla XR-ODT, enhancing Aytu's footprint in pediatrics and expanding its presence in adjacent specialty care segments.


    Lead Product(s): Methylphenidate

    Therapeutic Area: Psychiatry/Psychology Brand Name: Cotempla XR-ODT

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Aytu BioScience

    Deal Size: $44.9 million Upfront Cash: Undisclosed

    Deal Type: Merger December 10, 2020

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    Neos Therapeutics

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    Lead Product(s) : Methylphenidate

    Therapeutic Area : Psychiatry/Psychology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Aytu BioScience

    Deal Size : $44.9 million

    Deal Type : Merger

    DEALS_DEV arrow-down

    Aytu BioScience and Neos Therapeutics Announce Definitive Merger Agreement

    Details : Aytu adds Neos' established, multi-brand ADHD portfolio which includes Adzenys XR-ODT and Cotempla XR-ODT, enhancing Aytu's footprint in pediatrics and expanding its presence in adjacent specialty care segments.

    Brand Name : Cotempla XR-ODT

    Molecule Type : Small molecule

    Upfront Cash : Undisclosed

    December 10, 2020

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    Moksha8 Pharmaceuticals Announces Strategic Partnership with Janssen for Selected CNS Portfolio in Mexico

    Details:

    The strong and diverse portfolio includes: CONCERTA®, HALDOL®, HALDOL® DECANOAS, REMINYL®, SIBELIUM®, RISPERDAL®, RISPERDAL CONSTA® and TOPAMAX®.


    Lead Product(s): Methylphenidate

    Therapeutic Area: Psychiatry/Psychology Brand Name: Concerta

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Johnson & Johnson Innovative Medicine

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Agreement September 29, 2020

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    Moksha8 Pharmaceuticals

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    Lead Product(s) : Methylphenidate

    Therapeutic Area : Psychiatry/Psychology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Johnson & Johnson Innovative Medicine

    Deal Size : Undisclosed

    Deal Type : Agreement

    DEALS_DEV arrow-down

    Moksha8 Pharmaceuticals Announces Strategic Partnership with Janssen for Selected CNS Portfolio in...

    Details : The strong and diverse portfolio includes: CONCERTA®, HALDOL®, HALDOL® DECANOAS, REMINYL®, SIBELIUM®, RISPERDAL®, RISPERDAL CONSTA® and TOPAMAX®.

    Brand Name : Concerta

    Molecule Type : Small molecule

    Upfront Cash : Undisclosed

    September 29, 2020

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    South Africa

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    Pharmacare Limited, Woodmead

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    Regulatory Info : Originator

    Registration Country : South Africa

    Methylphenidate

    Brand Name : Adaphen Xl

    Dosage Form : SRT

    Dosage Strength : 20mg

    Packaging : 30X1mg

    Approval Date :

    Application Number :

    Regulatory Info : Originator

    Registration Country : South Africa

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    Pharmacare Limited, Woodmead

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    Regulatory Info : Generic

    Registration Country : South Africa

    Methylphenidate

    Brand Name : Adaphen

    Dosage Form : TAB

    Dosage Strength : 10mg

    Packaging : 30X1mg

    Approval Date :

    Application Number :

    Regulatory Info : Generic

    Registration Country : South Africa

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    Janssen Pharmaceutica (Pty) Ltd

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    Regulatory Info : Originator

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    Methylphenidate

    Brand Name : Concerta

    Dosage Form : TAB

    Dosage Strength : 36mg

    Packaging : 30X1mg

    Approval Date :

    Application Number :

    Regulatory Info : Originator

    Registration Country : South Africa

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    Janssen Pharmaceutica (Pty) Ltd

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    Regulatory Info : Originator

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    Methylphenidate

    Brand Name : Concerta

    Dosage Form : TAB

    Dosage Strength : 54mg

    Packaging : 30X1mg

    Approval Date :

    Application Number :

    Regulatory Info : Originator

    Registration Country : South Africa

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    Janssen Pharmaceutica (Pty) Ltd

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    Regulatory Info : Originator

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    Methylphenidate

    Brand Name : Concerta®

    Dosage Form : TAB

    Dosage Strength : 27mg

    Packaging : 30X1mg

    Approval Date :

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    Regulatory Info : Originator

    Registration Country : South Africa

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    Teva Pharmaceuticals (Pty) Ltd

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    Regulatory Info : Generic

    Registration Country : South Africa

    METHYLPHENIDATE

    Brand Name : ACERTA 18

    Dosage Form : TAB

    Dosage Strength : 18MG

    Packaging : 30X1MG

    Approval Date :

    Application Number :

    Regulatory Info : Generic

    Registration Country : South Africa

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    Teva Pharmaceuticals (Pty) Ltd

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    Israel
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    Regulatory Info : Generic

    Registration Country : South Africa

    METHYLPHENIDATE

    Brand Name : ACERTA 27

    Dosage Form : TAB

    Dosage Strength : 27MG

    Packaging : 30X1MG

    Approval Date :

    Application Number :

    Regulatory Info : Generic

    Registration Country : South Africa

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    Teva Pharmaceuticals (Pty) Ltd

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    Regulatory Info : Generic

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    METHYLPHENIDATE

    Brand Name : ACERTA 36

    Dosage Form : TAB

    Dosage Strength : 36MG

    Packaging : 30X1MG

    Approval Date :

    Application Number :

    Regulatory Info : Generic

    Registration Country : South Africa

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    Novartis South Africa (Pty) Ltd

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    Regulatory Info : Originator

    Registration Country : South Africa

    Methylphenidate

    Brand Name : Ritalin La

    Dosage Form : CAP

    Dosage Strength : 20mg

    Packaging : 30X1mg

    Approval Date :

    Application Number :

    Regulatory Info : Originator

    Registration Country : South Africa

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    Novartis South Africa (Pty) Ltd

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    Regulatory Info : Originator

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    Methylphenidate

    Brand Name : Ritalin La

    Dosage Form : CAP

    Dosage Strength : 30mg

    Packaging : 30X1mg

    Approval Date :

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    Regulatory Info : Originator

    Registration Country : South Africa

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    Listed Dossiers

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    01

    Cohance Lifesciences

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    Virtual BoothCohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

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    Cohance Lifesciences

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    Virtual BoothCohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

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    CHEMO

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    05

    CHEMO

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    CHEMO

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    DelNova Healthcare LLP

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    07

    DelNova Healthcare LLP

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    DelNova Healthcare LLP

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    DelNova Healthcare LLP

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    DelNova Healthcare LLP

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    DelNova Healthcare LLP

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    DOSAGE - TABLET, ORALLY DISINTEGRATING, EXTEN...DOSAGE - TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL - 17.3MG

    USFDA APPLICATION NUMBER - 205489

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    DOSAGE - TABLET, ORALLY DISINTEGRATING, EXTEN...DOSAGE - TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL - 25.9MG

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    DOSAGE - TABLET, ORALLY DISINTEGRATING, EXTEN...DOSAGE - TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL - 34.6MG

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    DOSAGE - TABLET, ORALLY DISINTEGRATING, EXTEN...DOSAGE - TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL - 8.6MG

    USFDA APPLICATION NUMBER - 205489

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