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Estradiol; norethindrone acetateis 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.
Summary for estradiol; norethindrone acetate
Recent Clinical Trials for estradiol; norethindrone acetate
Identify potential brand extensions & 505(b)(2) entrants
|University of Virginia||N/A|
|Ironwood Pharmaceuticals, Inc.||Phase 1|
|University of Pennsylvania||Phase 3|
Recent Litigation for estradiol; norethindrone acetate
Identify potential future generic entrants
District Court Litigation
|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|
Pharmacology for estradiol; norethindrone acetate
|Drug Class||Estrogen |
|Mechanism of Action||Estrogen Receptor Agonists |
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