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Generated: October 20, 2017

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Ethinyl estradiol; norethindrone - Generic Drug Details

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

Ethinyl estradiol; norethindrone
is the generic ingredient in one hundred and seven branded drugs marketed by Ortho Mcneil Pharm, Novast Labs Ltd, Mylan Labs Ltd, Lupin Ltd, Vintage Pharms, Warner Chilcott Llc, Janssen Pharms, Watson Labs, Warner Chilcott, Glenmark Generics, Aurobindo Pharma Ltd, Vintage Pharms Llc, Barr, LPI, Watson Labs Teva, Allergan Sales Llc, Ortho Mcneil Janssen, Accord Hlthcare, Apil, Mayne Pharma, Watson Pharms Teva, Amneal Pharms, Barr Labs Inc, Parke Davis, Glenmark Pharms Ltd, and Lupin Atlantis, and is included in one hundred and thirty-two 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-three suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for Generic Name: ethinyl estradiol; norethindrone

US Patents:3
Tradenames:107
Applicants:26
NDAs:132
Drug Master File Entries: see list26
Suppliers / Packagers: see list23
Bulk Api Vendors: see list4
Clinical Trials: see list701
Patent Applications: see list16
Drug Prices:see low prices
DailyMed Link:ethinyl estradiol; norethindrone at DailyMed

Pharmacology for Ingredient: ethinyl estradiol; norethindrone

Tentative approvals for ETHINYL ESTRADIOL; NORETHINDRONE

Applicant Application No. Strength Dosage Form
u► Subscribe0.02MG;1MGTABLET, CHEWABLE;ORAL
u► Subscribe0.01MG,0.01MG;1MG,N/ATABLET;ORAL
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Apil
FEMHRT
ethinyl estradiol; norethindrone acetate
TABLET;ORAL021065-001Jan 14, 2005ABRXNoNo► Subscribe► Subscribe► Subscribe
Aurobindo Pharma Ltd
NEXESTA FE
ethinyl estradiol; norethindrone
TABLET, CHEWABLE;ORAL207535-001Feb 2, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe
Mayne Pharma
MICROGESTIN 1/20
ethinyl estradiol; norethindrone acetate
TABLET;ORAL-21075647-002Jul 30, 2003ABRXNoNo► Subscribe► Subscribe► Subscribe
Apil
LO MINASTRIN FE
ethinyl estradiol; norethindrone acetate
TABLET, CHEWABLE, TABLET;ORAL204654-001Jul 24, 2013RXYesYes► Subscribe► Subscribe ► Subscribe
Mayne Pharma
TRI-NORINYL 21-DAY
ethinyl estradiol; norethindrone
TABLET;ORAL-21018977-001Apr 13, 1984DISCNNoNo► Subscribe► Subscribe► Subscribe
Apil
ESTROSTEP 21
ethinyl estradiol; norethindrone acetate
TABLET;ORAL-21020130-001Oct 9, 1996DISCNYesNo► Subscribe► Subscribe► Subscribe
Novast Labs Ltd
LERIBANE
ethinyl estradiol; norethindrone acetate
TABLET;ORAL203435-002Jun 3, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe
Apil
MINASTRIN 24 FE
ethinyl estradiol; norethindrone acetate
TABLET, CHEWABLE;ORAL203667-001May 8, 2013ABRXYesYes► Subscribe► SubscribeY ► Subscribe
Apil
LO MINASTRIN FE
ethinyl estradiol; norethindrone acetate
TABLET, CHEWABLE, TABLET;ORAL204654-001Jul 24, 2013RXYesYes► Subscribe► SubscribeY ► Subscribe
Lupin Ltd
FYAVOLV
ethinyl estradiol; norethindrone acetate
TABLET;ORAL204213-001Dec 10, 2015ABRXNoNo► Subscribe► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: ethinyl estradiol; norethindrone

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Pharms
ORTHO-NOVUM 7/7/7-21
ethinyl estradiol; norethindrone
TABLET;ORAL-21018985-001Apr 4, 1984► Subscribe► Subscribe
Apil
NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE
ethinyl estradiol; norethindrone
TABLET, CHEWABLE;ORAL022573-001Dec 22, 2010► Subscribe► Subscribe
Janssen Pharms
ORTHO-NOVUM 7/7/7-28
ethinyl estradiol; norethindrone
TABLET;ORAL-28018985-002Apr 4, 1984► Subscribe► Subscribe
Janssen Pharms
ORTHO-NOVUM 7/7/7-28
ethinyl estradiol; norethindrone
TABLET;ORAL-28018985-002Apr 4, 1984► Subscribe► Subscribe
Mayne Pharma
TRI-NORINYL 28-DAY
ethinyl estradiol; norethindrone
TABLET;ORAL-28018977-002Apr 13, 1984► Subscribe► Subscribe
Janssen Pharms
ORTHO-NOVUM 7/7/7-21
ethinyl estradiol; norethindrone
TABLET;ORAL-21018985-001Apr 4, 1984► Subscribe► Subscribe
Janssen Pharms
ORTHO-NOVUM 7/7/7-21
ethinyl estradiol; norethindrone
TABLET;ORAL-21018985-001Apr 4, 1984► Subscribe► Subscribe
Mayne Pharma
TRI-NORINYL 21-DAY
ethinyl estradiol; norethindrone
TABLET;ORAL-21018977-001Apr 13, 1984► Subscribe► Subscribe
Janssen Pharms
ORTHO-NOVUM 7/7/7-21
ethinyl estradiol; norethindrone
TABLET;ORAL-21018985-001Apr 4, 1984► Subscribe► Subscribe
Janssen Pharms
ORTHO-NOVUM 7/7/7-28
ethinyl estradiol; norethindrone
TABLET;ORAL-28018985-002Apr 4, 1984► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

Cerilliant
Express Scripts
Chubb
Johnson and Johnson
Harvard Business School
Daiichi Sankyo
Colorcon
Dow
Baxter
Healthtrust

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