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 Endo Operations, 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

US Patents and Regulatory Information for estradiol valerate

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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
Endo Operations	DELESTROGEN	estradiol valerate	INJECTABLE;INJECTION	009402-004	Approved Prior to Jan 1, 1982	AO	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hikma	ESTRADIOL VALERATE	estradiol valerate	INJECTABLE;INJECTION	203723-001	Apr 21, 2020	AO	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Savage Labs	DITATE-DS	estradiol valerate; testosterone enanthate	INJECTABLE;INJECTION	086423-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Dr Reddys	ESTRADIOL VALERATE	estradiol valerate	INJECTABLE;INJECTION	083714-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Am Regent	ESTRADIOL VALERATE	estradiol valerate	INJECTABLE;INJECTION	090920-002	Jan 19, 2010	AO	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Watson Labs	TESTOSTERONE ENANTHATE AND ESTRADIOL VALERATE	estradiol valerate; testosterone enanthate	INJECTABLE;INJECTION	085865-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Dr Reddys	ESTRADIOL VALERATE	estradiol valerate	INJECTABLE;INJECTION	083547-001	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:	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:	4,722
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

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	3MG;2MG;3MG	TABLET;ORAL
⤷ Sign Up	⤷ Sign Up	1MG;2MG;2MG	TABLET;ORAL

Drug Class	Estrogen
Mechanism of Action	Estrogen Receptor Agonists

Estradiol valerate - Generic Drug Details

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

Summary for estradiol valerate

Recent Clinical Trials for estradiol valerate

Generic filers with tentative approvals for ESTRADIOL VALERATE

Pharmacology for estradiol valerate

Anatomical Therapeutic Chemical (ATC) Classes for estradiol valerate

US Patents and Regulatory Information for estradiol valerate

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