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Last Updated: December 5, 2020

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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, 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-five 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.

Recent Clinical Trials for methyltestosterone

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Fundação de Amparo à Pesquisa do Estado de São PauloPhase 4
Federal University of São PauloPhase 4
Solvay PharmaceuticalsPhase 2

See all methyltestosterone clinical trials

Pharmacology for methyltestosterone
Drug ClassAndrogen
Mechanism of ActionAndrogen 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
Tablicaps METHYLTESTOSTERONE methyltestosterone TABLET;BUCCAL, SUBLINGUAL 085125-001 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Purepac Pharm METHYLTESTOSTERONE methyltestosterone TABLET;BUCCAL, SUBLINGUAL 080475-003 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Pvt Form METHYLTESTOSTERONE methyltestosterone TABLET;ORAL 080214-001 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Valeant Pharms North ANDROID 10 methyltestosterone TABLET;ORAL 086450-001 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Lannett METHYLTESTOSTERONE methyltestosterone TABLET;ORAL 087111-001 Jan 27, 1983 DISCN No No   Start Trial   Start Trial   Start 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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Serving leading biopharmaceutical companies globally:

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