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Last Updated: November 22, 2024

ESTRADIOL VALERATE - Generic Drug Details


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What are the generic drug sources for estradiol valerate and what is the scope of patent protection?

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
Drug Prices for ESTRADIOL VALERATE

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Recent Clinical Trials for ESTRADIOL VALERATE

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

SponsorPhase
ART Fertility Clinics LLCPhase 1
El Shatby University Hospital for Obstetrics and GynecologyPhase 2/Phase 3
University of California, San DiegoPhase 4

See all ESTRADIOL VALERATE clinical trials

Generic filers with tentative approvals for ESTRADIOL VALERATE
Applicant Application No. Strength Dosage Form
⤷  Sign Up⤷  Sign Up3MG;2MG;3MGTABLET;ORAL
⤷  Sign Up⤷  Sign Up1MG;2MG;2MGTABLET;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 ClassEstrogen
Mechanism of ActionEstrogen Receptor Agonists

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 ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Xiromed ESTRADIOL VALERATE estradiol valerate INJECTABLE;INJECTION 216656-003 Apr 28, 2023 AO RX No Yes ⤷  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
Am Regent ESTRADIOL VALERATE estradiol valerate INJECTABLE;INJECTION 090920-001 Jan 19, 2010 AO RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Xiromed ESTRADIOL VALERATE estradiol valerate INJECTABLE;INJECTION 216656-002 Apr 28, 2023 AO RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Hikma ESTRADIOL VALERATE estradiol valerate INJECTABLE;INJECTION 203723-003 Apr 21, 2020 AO RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Fosun Pharma ESTRADIOL VALERATE estradiol valerate INJECTABLE;INJECTION 040628-002 Oct 4, 2007 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

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