TESTOSTERONE CYPIONATE - Generic Drug Details

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What are the generic drug sources for testosterone cypionate and what is the scope of freedom to operate?

Testosterone cypionate is the generic ingredient in two branded drugs marketed by Pfizer, Am Regent, Cipla, Eugia Pharma, Hikma, Hikma Farmaceutica, Padagis Us, Rising, Sandoz, Sun Pharm Inds Ltd, Watson Labs, Watson Pharms Inc, Wilshire Pharms Inc, Xiromed, and Slayback Pharma Llc, and is included in sixteen NDAs. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

There are ten drug master file entries for testosterone cypionate. Eighteen suppliers are listed for this compound.

Sponsor	Phase
University of Sao Paulo	N/A
Fundação de Amparo à Pesquisa do Estado de São Paulo	N/A
Clarus Therapeutics	Phase 2

Sponsor

Phase

University of Sao Paulo

N/A

Fundação de Amparo à Pesquisa do Estado de São Paulo

N/A

Clarus Therapeutics

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
Wilshire Pharms Inc	TESTOSTERONE CYPIONATE	testosterone cypionate	INJECTABLE;INJECTION	206368-001	Apr 24, 2019	AO	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Watson Labs	TESTOSTERONE CYPIONATE	testosterone cypionate	INJECTABLE;INJECTION	084401-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Rising	TESTOSTERONE CYPIONATE	testosterone cypionate	INJECTABLE;INJECTION	040652-001	Dec 11, 2006		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Cipla	TESTOSTERONE CYPIONATE	testosterone cypionate	INJECTABLE;INJECTION	210362-001	Jun 19, 2018	AO	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Am Regent	TESTOSTERONE CYPIONATE	testosterone cypionate	INJECTABLE;INJECTION	207742-001	Jun 16, 2017	AO	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Hikma	TESTOSTERONE CYPIONATE	testosterone cypionate	INJECTABLE;INJECTION	090387-002	Jul 15, 2010	AO	RX	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

US Patents:	2
Tradenames:	2
Applicants:	15
NDAs:	16
Drug Master File Entries:	10
Finished Product Suppliers / Packagers:	18
Raw Ingredient (Bulk) Api Vendors:	44
Clinical Trials:	26
Patent Applications:	5,072
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for TESTOSTERONE CYPIONATE
What excipients (inactive ingredients) are in TESTOSTERONE CYPIONATE?	TESTOSTERONE CYPIONATE excipients list
DailyMed Link:	TESTOSTERONE CYPIONATE at DailyMed

Drug Class	Androgen
Mechanism of Action	Androgen Receptor Agonists