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Last Updated: November 5, 2024

ESTRACE Drug Patent Profile


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When do Estrace patents expire, and when can generic versions of Estrace launch?

Estrace is a drug marketed by Allergan and Bristol Myers Squibb and is included in four NDAs.

The generic ingredient in ESTRACE is estradiol. There are seventy-five drug master file entries for this compound. Forty-nine suppliers are listed for this compound. Additional details are available on the estradiol profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Estrace

A generic version of ESTRACE was approved as estradiol by BARR LABS INC on October 22nd, 1997.

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Drug patent expirations by year for ESTRACE
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Drug Sales Revenue Trends for ESTRACE

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Recent Clinical Trials for ESTRACE

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SponsorPhase
Breast Cancer Research FoundationPhase 2
University of WashingtonPhase 2
Gary SchwartzPhase 1

See all ESTRACE clinical trials

Pharmacology for ESTRACE
Drug ClassEstrogen
Mechanism of ActionEstrogen Receptor Agonists

US Patents and Regulatory Information for ESTRACE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Allergan ESTRACE estradiol CREAM;VAGINAL 086069-001 Jan 31, 1984 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Bristol Myers Squibb ESTRACE estradiol TABLET;ORAL 084500-001 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Bristol Myers Squibb ESTRACE estradiol TABLET;ORAL 081295-001 Jun 30, 1993 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Bristol Myers Squibb ESTRACE estradiol TABLET;ORAL 084499-001 Approved Prior to Jan 1, 1982 DISCN Yes 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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