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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 thirty-six branded drugs marketed by Warner Chilcott, Warner Chilcott Llc, Vintage Pharms, Novast Labs Ltd, Barr Labs Inc, Glenmark Generics, Amneal Pharms, Famy Care Ltd, Vintage Pharms Llc, Barr, Watson Labs, and Parke Davis, and is included in forty 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-six 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:36
Patents:4
Applicants:12
NDAs:40
Drug Master File Entries: see list26
Suppliers: see list4
Formulation / Manufacturing:see details

Pharmacology for Ingredient: ethinyl estradiol; norethindrone acetate

Clinical Trials for: ethinyl estradiol; norethindrone acetate

Glossary
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Barr
TRI-LEGEST FE
ethinyl estradiol; norethindrone acetate
TABLET;ORAL-28076105-001Oct 26, 2007RXNo<disabled><disabled>
Watson Labs
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL
ethinyl estradiol; norethindrone acetate
TABLET;ORAL-28076629-001Mar 18, 2010RXNo<disabled><disabled>
Warner Chilcott Llc
FEMHRT
ethinyl estradiol; norethindrone acetate
TABLET;ORAL021065-002Oct 15, 1999DISCNNo<disabled><disabled>
Warner Chilcott Llc
MINASTRIN 24 FE
ethinyl estradiol; norethindrone acetate
TABLET, CHEWABLE;ORAL203667-001May 8, 2013RXYes6,667,050<disabled>Y<disabled>
Warner Chilcott Llc
LOESTRIN FE 1.5/30
ethinyl estradiol; norethindrone acetate
TABLET;ORAL-28017355-001Approved Prior to Jan 1, 1982RXYes<disabled><disabled>
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International Patent Family for Ingredient: ethinyl estradiol; norethindrone acetate

Country Document Number Publication Date
Japan4636692Feb 23, 2011
Russian Federation2001129365Feb 20, 2004
Australia763971Aug 07, 2003
Canada2605299Nov 02, 2006
Australia4049400Oct 23, 2000
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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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