Methyltestosterone - Generic Drug Details
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What are the generic drug sources for methyltestosterone and what is the scope of patent protection?
Methyltestosterone
is the generic ingredient in nine branded drugs marketed by Heather, Impax Labs Inc, Novitium Pharma, Bausch, Chartwell, Valeant Pharm Intl, Schering, Novartis, Impax Labs, Lilly, Purepac Pharm, Pvt Form, Tablicaps, Usl Pharma, Valeant Pharms North, Inwood Labs, Kv Pharm, Lannett, Parke Davis, Watson Labs, and West Ward, and is included in thirty-six NDAs. Additional information is available in the individual branded drug profile pages.There are nine drug master file entries for methyltestosterone. Two suppliers are listed for this compound.
Summary for methyltestosterone
US Patents: | 0 |
Tradenames: | 9 |
Applicants: | 21 |
NDAs: | 36 |
Drug Master File Entries: | 9 |
Finished Product Suppliers / Packagers: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 57 |
Clinical Trials: | 2 |
Patent Applications: | 6,886 |
What excipients (inactive ingredients) are in methyltestosterone? | methyltestosterone excipients list |
DailyMed Link: | methyltestosterone at DailyMed |
Recent Clinical Trials for methyltestosterone
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Federal University of São Paulo | Phase 4 |
Fundação de Amparo à Pesquisa do Estado de São Paulo | Phase 4 |
Solvay Pharmaceuticals | Phase 2 |
Pharmacology for methyltestosterone
Drug Class | Androgen |
Mechanism of Action | Androgen Receptor Agonists |
Medical Subject Heading (MeSH) Categories for methyltestosterone
Anatomical Therapeutic Chemical (ATC) Classes for methyltestosterone
US Patents and Regulatory Information for methyltestosterone
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Purepac Pharm | METHYLTESTOSTERONE | methyltestosterone | TABLET;ORAL | 080309-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Lilly | METHYLTESTOSTERONE | methyltestosterone | TABLET;BUCCAL, SUBLINGUAL | 080256-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Valeant Pharm Intl | ANDROID 25 | methyltestosterone | TABLET;ORAL | 087147-001 | Approved Prior to Jan 1, 1982 | BP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
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