Testosterone cypionate - Generic Drug Details

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What are the generic 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
Dendreon	Phase 2
Yale University	Phase 2

Sponsor

Phase

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

Phase 2

Dendreon

Phase 2

Yale University

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	TESTOSTERONE CYPIONATE	testosterone cypionate	INJECTABLE;INJECTION	090387-002	Jul 15, 2010	AO	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hikma	TESTOSTERONE CYPIONATE	testosterone cypionate	INJECTABLE;INJECTION	090387-001	Jul 15, 2010	AO	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Cipla	TESTOSTERONE CYPIONATE	testosterone cypionate	INJECTABLE;INJECTION	210362-002	Jun 19, 2018	AO	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Eugia Pharma	TESTOSTERONE CYPIONATE	testosterone cypionate	INJECTABLE;INJECTION	211817-002	Oct 20, 2023	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