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Last Updated: December 14, 2019

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Estradiol; norethindrone acetate - Generic Drug Details

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What are the generic drug sources for estradiol; norethindrone acetate and what is the scope of freedom to operate?

Estradiol; norethindrone acetate is the generic ingredient in four branded drugs marketed by Noven Pharms Inc, Amneal Pharms Llc, Lupin Ltd, Accord Hlthcare, Barr, Breckenridge Pharm, Mylan Labs Ltd, Novast Labs, and Teva Pharms Usa, and is included in nine NDAs. Additional information is available in the individual branded drug profile pages.

There are seventy-five drug master file entries for estradiol; norethindrone acetate. Nine suppliers are listed for this compound.

Recent Clinical Trials for estradiol; norethindrone acetate

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

SponsorPhase
University of VirginiaN/A
Ironwood Pharmaceuticals, Inc.Phase 1
Milton S. Hershey Medical CenterPhase 3

See all estradiol; norethindrone acetate clinical trials

Recent Litigation for estradiol; norethindrone acetate

Identify potential future generic entrants

District Court Litigation
Case NameDate
Teva Women's Health, Inc. v. Famy Care Ltd.2014-12-05
Abbott Products Inc. v. Teva Pharamceuticals USA, Inc.2011-04-29
Vivelle Ventures LLC v. Mylan Technologies, Inc.2011-02-22

See all estradiol; norethindrone acetate litigation

Pharmacology for estradiol; norethindrone acetate

US Patents and Regulatory Information for estradiol; norethindrone acetate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mylan Labs Ltd ESTRADIOL AND NORETHINDRONE ACETATE estradiol; norethindrone acetate TABLET;ORAL 207261-002 Feb 10, 2017 AB RX No No   Start Trial   Start Trial   Start Trial
Novast Labs ESTRADIOL AND NORETHINDRONE ACETATE estradiol; norethindrone acetate TABLET;ORAL 210612-001 Apr 3, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Amneal Pharms Llc ACTIVELLA estradiol; norethindrone acetate TABLET;ORAL 020907-002 Dec 28, 2006 AB RX Yes No   Start Trial   Start Trial   Start Trial
Amneal Pharms Llc ACTIVELLA estradiol; norethindrone acetate TABLET;ORAL 020907-001 Nov 18, 1998 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Barr ESTRADIOL AND NORETHINDRONE ACETATE estradiol; norethindrone acetate TABLET;ORAL 079193-001 May 11, 2010 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

Expired US Patents for estradiol; norethindrone acetate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Noven Pharms Inc COMBIPATCH estradiol; norethindrone acetate FILM, EXTENDED RELEASE;TRANSDERMAL 020870-002 Aug 7, 1998   Start Trial   Start Trial
Noven Pharms Inc COMBIPATCH estradiol; norethindrone acetate FILM, EXTENDED RELEASE;TRANSDERMAL 020870-001 Aug 7, 1998   Start Trial   Start Trial
Noven Pharms Inc COMBIPATCH estradiol; norethindrone acetate FILM, EXTENDED RELEASE;TRANSDERMAL 020870-002 Aug 7, 1998   Start Trial   Start Trial
Amneal Pharms Llc ACTIVELLA estradiol; norethindrone acetate TABLET;ORAL 020907-001 Nov 18, 1998   Start Trial   Start Trial
Noven Pharms Inc COMBIPATCH estradiol; norethindrone acetate FILM, EXTENDED RELEASE;TRANSDERMAL 020870-002 Aug 7, 1998   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Express Scripts
McKesson
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Dow
Johnson and Johnson

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