Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Serving leading biopharmaceutical companies globally:

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Last Updated: December 7, 2019

DrugPatentWatch Database Preview

Estradiol; norethindrone acetate - Generic Drug Details

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What are the generic 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

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SponsorPhase
University of VirginiaN/A
Ironwood Pharmaceuticals, Inc.Phase 1
University of PennsylvaniaPhase 3

See all estradiol; norethindrone acetate clinical trials

Recent Litigation for estradiol; norethindrone acetate

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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
Breckenridge Pharm ESTRADIOL AND NORETHINDRONE ACETATE estradiol; norethindrone acetate TABLET;ORAL 078324-002 Jun 9, 2011 AB RX No No   Start Trial   Start Trial   Start Trial
Breckenridge Pharm ESTRADIOL AND NORETHINDRONE ACETATE estradiol; norethindrone acetate TABLET;ORAL 078324-001 Apr 17, 2008 AB RX No No   Start Trial   Start Trial   Start Trial
Accord Hlthcare ESTRADIOL AND NORETHINDRONE ACETATE estradiol; norethindrone acetate TABLET;ORAL 210233-001 Feb 28, 2018 DISCN No No   Start Trial   Start Trial   Start Trial
Noven Pharms Inc COMBIPATCH estradiol; norethindrone acetate FILM, EXTENDED RELEASE;TRANSDERMAL 020870-001 Aug 7, 1998 RX Yes No   Start Trial   Start Trial   Start Trial
Lupin Ltd AMABELZ estradiol; norethindrone acetate TABLET;ORAL 203339-001 Jun 20, 2016 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 020870-001 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
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
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:

AstraZeneca
Dow
Moodys
McKesson
Express Scripts
Boehringer Ingelheim

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