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Last Updated: April 25, 2024

Estradiol valerate - Generic Drug Details


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

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.

Drug Prices for estradiol valerate

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Recent Clinical Trials for estradiol valerate

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

SponsorPhase
El Shatby University Hospital for Obstetrics and GynecologyPhase 2/Phase 3
University of California, San DiegoPhase 4
Sohag UniversityEarly Phase 1

See all estradiol valerate clinical trials

Generic filers with tentative approvals for ESTRADIOL VALERATE
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a Trial3MG;2MG;3MGTABLET;ORAL
⤷  Try a Trial⤷  Try a Trial1MG;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
Savage Labs DITATE-DS estradiol valerate; testosterone enanthate INJECTABLE;INJECTION 086423-001 Approved Prior to Jan 1, 1982 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
Am Regent ESTRADIOL VALERATE estradiol valerate INJECTABLE;INJECTION 090920-002 Jan 19, 2010 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

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.