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Ethinyl estradiol; norethindrone - Generic Drug Details

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Ethinyl estradiol; norethindrone is the generic ingredient in ninety-seven branded drugs marketed by Ortho Mcneil Pharm, Novast Labs Ltd, Jai Pharma Ltd, Lupin Ltd, Vintage Pharms, Warner Chilcott Llc, Janssen Pharms, Watson Labs, Warner Chilcott, Glenmark Generics, Vintage Pharms Llc, Barr, LPI, Allergan Sales Llc, Ortho Mcneil Janssen, Apil, Actavis Labs Ut Inc, Amneal Pharms, Barr Labs Inc, Parke Davis, Glenmark Pharms Ltd, and Lupin Atlantis, and is included in one hundred and seventeen NDAs. There are three patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

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

Summary for Generic Name: ethinyl estradiol; norethindrone

Tradenames:97
Patents:3
Applicants:22
NDAs:117
Drug Master File Entries: see list26
Suppliers / Packaging: see list20
Formulation / Manufacturing:see details

Pharmacology for Ingredient: ethinyl estradiol; norethindrone

Clinical Trials for: ethinyl estradiol; norethindrone

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Barr
JUNEL 1/20
ethinyl estradiol; norethindrone acetate
TABLET;ORAL-21076380-001May 30, 2003RXNo<disabled><disabled>
Lupin Atlantis
MIBELAS 24 FE
ethinyl estradiol; norethindrone acetate
TABLET, CHEWABLE;ORAL206287-001May 24, 2016RXNo<disabled><disabled>
Vintage Pharms
GILDAGIA
ethinyl estradiol; norethindrone
TABLET;ORAL-28078376-001Nov 6, 2012RXNo<disabled><disabled>
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Expired Orange Book Patents for Generic Ingredient: ethinyl estradiol; norethindrone

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Actavis Labs Ut Inc
TRI-NORINYL 21-DAY
ethinyl estradiol; norethindrone
TABLET;ORAL-21018977-001Apr 13, 19844,390,531<disabled>
Janssen Pharms
ORTHO-NOVUM 7/7/7-21
ethinyl estradiol; norethindrone
TABLET;ORAL-21018985-001Apr 4, 19844,544,554<disabled>
Janssen Pharms
ORTHO-NOVUM 7/7/7-21
ethinyl estradiol; norethindrone
TABLET;ORAL-21018985-001Apr 4, 19844,530,839<disabled>
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