Estradiol valerate - Generic Drug Details

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.

Summary for estradiol valerate

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:	67
Patent Applications:	4,722
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

See drug prices for estradiol valerate

Recent Clinical Trials for estradiol valerate

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
ART Fertility Clinics LLC	Phase 1
El Shatby University Hospital for Obstetrics and Gynecology	Phase 2/Phase 3
University of California, San Diego	Phase 4

See all estradiol valerate clinical trials

Generic filers with tentative approvals for ESTRADIOL VALERATE

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

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for estradiol valerate

Drug Class	Estrogen
Mechanism of Action	Estrogen Receptor Agonists

Anatomical Therapeutic Chemical (ATC) Classes for estradiol valerate

G03CA	Natural and semisynthetic estrogens, plain
G03C	ESTROGENS
G03	SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
G	Genito-urinary system and sex hormones

US Patents and Regulatory Information for estradiol valerate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hikma	ESTRADIOL VALERATE	estradiol valerate	INJECTABLE;INJECTION	203723-001	Apr 21, 2020	AO	RX	No	No
Xiromed	ESTRADIOL VALERATE	estradiol valerate	INJECTABLE;INJECTION	216656-003	Apr 28, 2023	AO	RX	No	Yes
Savage Labs	DITATE-DS	estradiol valerate; testosterone enanthate	INJECTABLE;INJECTION	086423-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Am Regent	ESTRADIOL VALERATE	estradiol valerate	INJECTABLE;INJECTION	090920-001	Jan 19, 2010	AO	RX	No	No
Xiromed	ESTRADIOL VALERATE	estradiol valerate	INJECTABLE;INJECTION	216656-002	Apr 28, 2023	AO	RX	No	No