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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

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:

Express Scripts
Johnson and Johnson

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.