Estradiol valerate - Generic Drug Details

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What are the generic sources for estradiol valerate and what is the scope of freedom to operate?

Estradiol valerate is the generic ingredient in four branded drugs marketed by Par Sterile Products, Am Regent, Dr Reddys, Fosun Pharma, Hikma, Watson Labs, Xiromed, and Savage Labs, and is included in eleven NDAs. Additional information is available in the individual branded drug profile pages.

There are seven drug master file entries for estradiol valerate. Four suppliers are listed for this compound. There is one tentative approval for this compound.

Sponsor	Phase
El Shatby University Hospital for Obstetrics and Gynecology	Phase 2/Phase 3
University of California, San Diego	Phase 4
Sohag University	Early Phase 1

Sponsor

Phase

El Shatby University Hospital for Obstetrics and Gynecology

Phase 2/Phase 3

University of California, San Diego

Phase 4

Sohag University

Early Phase 1

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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
Watson Labs	TESTOSTERONE ENANTHATE AND ESTRADIOL VALERATE	estradiol valerate; testosterone enanthate	INJECTABLE;INJECTION	085860-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Fosun Pharma	ESTRADIOL VALERATE	estradiol valerate	INJECTABLE;INJECTION	040628-003	Oct 4, 2007		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Watson Labs	ESTRADIOL VALERATE	estradiol valerate	INJECTABLE;INJECTION	083546-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Fosun Pharma	ESTRADIOL VALERATE	estradiol valerate	INJECTABLE;INJECTION	040628-001	Oct 4, 2007		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Hikma	ESTRADIOL VALERATE	estradiol valerate	INJECTABLE;INJECTION	203723-003	Apr 21, 2020	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:	0
Tradenames:	4
Applicants:	8
NDAs:	11
Drug Master File Entries:	7
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	79
Clinical Trials:	66
Patent Applications:	5,040
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for estradiol valerate
What excipients (inactive ingredients) are in estradiol valerate?	estradiol valerate excipients list
DailyMed Link:	estradiol valerate at DailyMed

Drug Class	Estrogen
Mechanism of Action	Estrogen Receptor Agonists