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Last Updated: April 18, 2021

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ESTRADIOL Drug Profile

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Which patents cover Estradiol, and when can generic versions of Estradiol launch?

Estradiol is a drug marketed by Alvogen Pine Brook, Mylan, Perrigo Uk Finco, Teva Pharms Usa, Amneal, Mylan Technologies, Ortho Mcneil Pharm, Barr Labs Inc, Epic Pharma Inc, Lannett Holdings Inc, Mayne Pharma, Usl Pharma, Amneal Pharms, Glenmark Pharms Ltd, Barr, Breckenridge Pharm, Mylan Labs Ltd, Naari Pte Ltd, Novast Labs, Dr Reddys, Am Regent, Fosun Pharma, Hikma, and Watson Labs. and is included in thirty-three NDAs.

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

DrugPatentWatch® Litigation and Generic Entry Outlook for Estradiol

A generic version of ESTRADIOL was approved as estradiol valerate by AM REGENT on January 19th, 2010.

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Drug patent expirations by year for ESTRADIOL
Drug Prices for ESTRADIOL

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Drug Sales Revenue Trends for ESTRADIOL

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Recent Clinical Trials for ESTRADIOL

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SponsorPhase
Merck, S.L., SpainPhase 4
Fundación Santiago Dexeus FontPhase 4
IRCCS San RaffaelePhase 4

See all ESTRADIOL clinical trials

Pharmacology for ESTRADIOL
Drug ClassEstrogen
Mechanism of ActionEstrogen Receptor Agonists
Medical Subject Heading (MeSH) Categories for ESTRADIOL
Paragraph IV (Patent) Challenges for ESTRADIOL
Tradename Dosage Ingredient NDA Submissiondate
IMVEXXY INSERT;VAGINAL estradiol 208564 2019-12-30
MINIVELLE FILM, EXTENDED RELEASE;TRANSDERMAL estradiol 203752 2015-05-08
MINIVELLE FILM, EXTENDED RELEASE;TRANSDERMAL estradiol 203752 2014-08-18
VAGIFEM TABLET;VAGINAL estradiol 020908 2013-01-02
VIVELLE-DOT SYSTEM;TRANSDERMAL estradiol 020538 2010-04-27
CLIMARA FILM, EXTENDED RELEASE;TRANSDERMAL estradiol 020375 2005-09-12

US Patents and Regulatory Information for ESTRADIOL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Fosun Pharma ESTRADIOL VALERATE estradiol valerate INJECTABLE;INJECTION 040628-003 Oct 4, 2007 DISCN No No   Start Trial   Start Trial   Start Trial
Lannett Holdings Inc ESTRADIOL estradiol TABLET;ORAL 040138-002 Jan 30, 1998 DISCN No No   Start Trial   Start Trial   Start Trial
Ortho Mcneil Pharm ESTRADIOL estradiol SYSTEM;TRANSDERMAL 021048-002 Sep 20, 1999 DISCN No No   Start Trial   Start Trial   Start Trial
Usl Pharma ESTRADIOL estradiol TABLET;ORAL 040297-001 Apr 17, 2002 DISCN No No   Start Trial   Start Trial   Start Trial
Naari Pte Ltd ESTRADIOL AND NORETHINDRONE ACETATE estradiol; norethindrone acetate TABLET;ORAL 210233-001 Feb 28, 2018 DISCN No No   Start Trial   Start Trial   Start Trial
Mayne Pharma ESTRADIOL estradiol TABLET;ORAL 040114-002 Mar 14, 1996 AB RX 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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