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 Azurity, 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. Twenty suppliers are listed for this compound.

Sponsor	Phase
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Phase 2
Yale University	Phase 2
Dendreon	Phase 2

Sponsor

Phase

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Phase 2

Yale University

Phase 2

Dendreon

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
Hikma Farmaceutica	TESTOSTERONE CYPIONATE	testosterone cypionate	INJECTABLE;INJECTION	091244-001	May 1, 2012	AO	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sun Pharm Inds Ltd	TESTOSTERONE CYPIONATE	testosterone cypionate	INJECTABLE;INJECTION	201720-002	Jun 3, 2013	AO	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Watson Labs	TESTOSTERONE CYPIONATE	testosterone cypionate	INJECTABLE;INJECTION	084401-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Am Regent	TESTOSTERONE CYPIONATE	testosterone cypionate	INJECTABLE;INJECTION	207742-001	Jun 16, 2017	AO	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sun Pharm Inds Ltd	TESTOSTERONE CYPIONATE	testosterone cypionate	INJECTABLE;INJECTION	201720-001	Jun 3, 2013	AO	RX	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:	2
Tradenames:	2
Applicants:	15
NDAs:	16
Drug Master File Entries:	10
Finished Product Suppliers / Packagers:	20
Raw Ingredient (Bulk) Api Vendors:	44
Clinical Trials:	30
Patent Applications:	4,770
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