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Last Updated: August 3, 2021

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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.

Drug Prices for ESTRADIOL VALERATE

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Recent Clinical Trials for ESTRADIOL VALERATE

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SponsorPhase
Aljazeera HospitalN/A
Bezmialem Vakif UniversityN/A
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
⤷  Try it Free⤷  Try it Free3MG;2MG;3MGTABLET;ORAL
⤷  Try it Free⤷  Try it Free1MG;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
Watson Labs TESTOSTERONE ENANTHATE AND ESTRADIOL VALERATE estradiol valerate; testosterone enanthate INJECTABLE;INJECTION 085860-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Fosun Pharma ESTRADIOL VALERATE estradiol valerate INJECTABLE;INJECTION 040628-002 Oct 4, 2007 DISCN No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Watson Labs TESTOSTERONE ENANTHATE AND ESTRADIOL VALERATE estradiol valerate; testosterone enanthate INJECTABLE;INJECTION 085865-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Watson Labs ESTRADIOL VALERATE estradiol valerate INJECTABLE;INJECTION 083546-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Par Sterile Products DELESTROGEN estradiol valerate INJECTABLE;INJECTION 009402-004 Approved Prior to Jan 1, 1982 AO RX Yes Yes ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
>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:

Colorcon
Baxter
Boehringer Ingelheim
Dow
Medtronic
Johnson and Johnson

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