Methyltestosterone - Generic Drug Details
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What are the generic sources for methyltestosterone and what is the scope of freedom to operate?
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. One supplier is 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: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 57 |
Clinical Trials: | 2 |
Patent Applications: | 6,882 |
Formulation / Manufacturing: | see details |
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 |
---|---|
Fundação de Amparo à Pesquisa do Estado de São Paulo | Phase 4 |
Federal University of 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
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Novartis | METANDREN | methyltestosterone | TABLET;BUCCAL, SUBLINGUAL | 003240-003 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Tablicaps | METHYLTESTOSTERONE | methyltestosterone | TABLET;ORAL | 080313-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Lannett | METHYLTESTOSTERONE | methyltestosterone | TABLET;ORAL | 087111-001 | Jan 27, 1983 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Valeant Pharm Intl | ANDROID 25 | methyltestosterone | TABLET;ORAL | 087147-001 | Approved Prior to Jan 1, 1982 | BP | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Parke Davis | METHYLTESTOSTERONE | methyltestosterone | TABLET;ORAL | 084244-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Valeant Pharms North | ANDROID 10 | methyltestosterone | TABLET;ORAL | 086450-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
>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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