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Last Updated: August 7, 2020

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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 Par Sterile Products, Am Regent, Dr Reddys, Fosun Pharma, Hikma, Watson Labs, and Savage Labs, and is included in ten NDAs. Additional information is available in the individual branded drug profile pages.

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


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Recent Clinical Trials for ESTRADIOL VALERATE

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

University of California, San DiegoPhase 4
Cairo UniversityPhase 1
University Hospital, GhentPhase 3

See all ESTRADIOL VALERATE clinical trials

Generic filers with tentative approvals for ESTRADIOL VALERATE
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial3MG;2MG;3MGTABLET;ORAL
  Start Trial  Start 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.

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
Watson Labs TESTOSTERONE ENANTHATE AND ESTRADIOL VALERATE estradiol valerate; testosterone enanthate INJECTABLE;INJECTION 085865-001 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Am Regent ESTRADIOL VALERATE estradiol valerate INJECTABLE;INJECTION 090920-002 Jan 19, 2010 AO RX No No   Start Trial   Start Trial   Start Trial
Fosun Pharma ESTRADIOL VALERATE estradiol valerate INJECTABLE;INJECTION 040628-001 Oct 4, 2007 DISCN No No   Start Trial   Start Trial   Start 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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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Johnson and Johnson

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.