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Last Updated: August 15, 2022

Estradiol valerate - Generic Drug Details


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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 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 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

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SponsorPhase
University of California, San DiegoPhase 4
Sohag UniversityEarly Phase 1
Laboratorios Andromaco S.A.Phase 1

See all estradiol valerate clinical trials

Generic filers with tentative approvals for ESTRADIOL VALERATE
Applicant Application No. Strength Dosage Form
See Plans and PricingSee Plans and Pricing3MG;2MG;3MGTABLET;ORAL
See Plans and PricingSee Plans and Pricing1MG;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 Class Estrogen
Mechanism of Action Estrogen 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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Am Regent ESTRADIOL VALERATE estradiol valerate INJECTABLE;INJECTION 090920-002 Jan 19, 2010 AO RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Par Sterile Products DELESTROGEN estradiol valerate INJECTABLE;INJECTION 009402-004 Approved Prior to Jan 1, 1982 AO RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Watson Labs TESTOSTERONE ENANTHATE AND ESTRADIOL VALERATE estradiol valerate; testosterone enanthate INJECTABLE;INJECTION 085860-001 Approved Prior to Jan 1, 1982 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Fosun Pharma ESTRADIOL VALERATE estradiol valerate INJECTABLE;INJECTION 040628-003 Oct 4, 2007 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Par Sterile Products DELESTROGEN estradiol valerate INJECTABLE;INJECTION 009402-003 Approved Prior to Jan 1, 1982 AO RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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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