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Details for Generic Name: ethinyl estradiol; norethindrone acetate

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

This ingredient has thirty-eight patent family members in twenty-four countries.

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

Summary for Generic Name: ethinyl estradiol; norethindrone acetate

Tradenames:40
Patents:4
Applicants:13
NDAs:44
Drug Master File Entries: see list26
Suppliers / Packaging: see list23

Pharmacology for Ingredient: ethinyl estradiol; norethindrone acetate

Clinical Trials for: ethinyl estradiol; norethindrone acetate

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Warner Chilcott Llc
FEMHRT
ethinyl estradiol; norethindrone acetate
TABLET;ORAL021065-001Jan 14, 2005RXNo<disabled><disabled>
Watson Labs
MICROGESTIN FE 1.5/30
ethinyl estradiol; norethindrone acetate
TABLET;ORAL-28075548-001Feb 5, 2001RXNo<disabled><disabled>
Warner Chilcott Llc
LO LOESTRIN FE
ethinyl estradiol; norethindrone acetate
TABLET;ORAL022501-001Oct 21, 2010RXYes7,704,984<disabled> <disabled>
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Expired Orange Book Patents for Generic Ingredient: ethinyl estradiol; norethindrone acetate

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Warner Chilcott Llc
ESTROSTEP FE
ethinyl estradiol; norethindrone acetate
TABLET;ORAL-28020130-002Oct 9, 19965,010,070<disabled>
Warner Chilcott
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE
ethinyl estradiol; norethindrone acetate
CAPSULE;ORAL204426-001Apr 19, 20135,552,394<disabled>
Warner Chilcott Llc
ESTROSTEP FE
ethinyl estradiol; norethindrone acetate
TABLET;ORAL-28020130-002Oct 9, 19964,962,098<disabled>
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International Patent Family for Ingredient: ethinyl estradiol; norethindrone acetate

Country Document Number Publication Date
Israel186656Mar 29, 2012
Norway20014719Sep 28, 2001
United Kingdom9907715May 26, 1999
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors.

Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided information. There is no warranty that the information contained herein is error free. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

Copyright 2002-2016 thinkBiotech LLC
ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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