METHYLTESTOSTERONE - Generic Drug Details

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What are the generic drug 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. Two suppliers are listed for this compound.

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

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

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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	003240-005	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
West Ward	METHYLTESTOSTERONE	methyltestosterone	TABLET;ORAL	084331-002	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
West Ward	METHYLTESTOSTERONE	methyltestosterone	TABLET;ORAL	084331-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Novartis	METANDREN	methyltestosterone	TABLET;BUCCAL, SUBLINGUAL	003240-001	Approved Prior to Jan 1, 1982		DISCN	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

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

Drug Class	Androgen
Mechanism of Action	Androgen Receptor Agonists