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Generated: April 30, 2017

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Ethinyl estradiol; norethindrone acetate - Generic Drug Details

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

Ethinyl estradiol; norethindrone acetate
is the generic ingredient in forty-four branded drugs marketed by Apil, Barr, Lupin Ltd, Barr Labs Inc, Parke Davis, Mayne Pharma, Novast Labs Ltd, Glenmark Generics, Mylan Labs Ltd, Amneal Pharms, Glenmark Pharms Ltd, Vintage Pharms Llc, Lupin Atlantis, and Vintage Pharms, and is included in fifty NDAs. There are four patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Ethinyl estradiol; norethindrone acetate has thirty-eight patent family members in twenty-four countries.

There are twenty-six drug master file entries for ethinyl estradiol; norethindrone acetate. Twenty-one suppliers are listed for this compound.

Summary for Generic Name: ethinyl estradiol; norethindrone acetate

Drug Master File Entries: see list26
Suppliers / Packagers: see list21
Clinical Trials: see list660
Drug Prices:see low prices
DailyMed Link:ethinyl estradiol; norethindrone acetate at DailyMed

Pharmacology for Ingredient: ethinyl 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
JUNEL 1.5/30
ethinyl estradiol; norethindrone acetate
TABLET;ORAL-21076381-001May 30, 2003ABRXNoNo► Subscribe► Subscribe
Novast Labs Ltd
ethinyl estradiol; norethindrone acetate
TABLET;ORAL202994-001Feb 18, 2015ABRXNoNo► Subscribe► Subscribe
Mylan Labs Ltd
ethinyl estradiol; norethindrone acetate
TABLET;ORAL205049-001May 31, 2016ABRXNoNo► Subscribe► Subscribe
Mayne Pharma
ethinyl estradiol; norethindrone acetate
TABLET;ORAL-28075548-001Feb 5, 2001ABRXNoNo► Subscribe► Subscribe
ethinyl estradiol; norethindrone acetate
CAPSULE;ORAL204426-001Apr 19, 2013RXYesYes6,652,880► SubscribeY ► Subscribe
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