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Ethinyl estradiol; norethindrone - Generic Drug Details

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Ethinyl estradiol; norethindrone is the generic ingredient in one hundred and one 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, Aurobindo Pharma Ltd, Apil, Mayne Pharma, Amneal Pharms, Barr Labs Inc, Parke Davis, Glenmark Pharms Ltd, and Lupin Atlantis, and is included in one hundred and twenty 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-two suppliers are listed for this compound.

Summary for Generic Name: ethinyl estradiol; norethindrone

Tradenames:101
Patents:3
Applicants:23
NDAs:120
Drug Master File Entries: see list26
Suppliers / Packaging: see list22
Formulation / Manufacturing:see details
Drug Prices:see low prices

Pharmacology for Ingredient: ethinyl estradiol; norethindrone

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Vintage Pharms Llc
CYCLAFEM 7/7/7
ethinyl estradiol; norethindrone
TABLET;ORAL-28076338-001Nov 16, 2010RXNo► subscribe► subscribe
Apil
LOESTRIN FE 1.5/30
ethinyl estradiol; norethindrone acetate
TABLET;ORAL-28017355-001Approved Prior to Jan 1, 1982RXYes► subscribe► subscribe
Vintage Pharms Llc
GILDESS 1.5/30
ethinyl estradiol; norethindrone acetate
TABLET;ORAL-21077075-002Jul 24, 2012RXNo► 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
Mayne Pharma
TRI-NORINYL 21-DAY
ethinyl estradiol; norethindrone
TABLET;ORAL-21018977-001Apr 13, 19844,390,531► subscribe
Apil
NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE
ethinyl estradiol; norethindrone
TABLET, CHEWABLE;ORAL022573-001Dec 22, 20105,552,394► subscribe
Janssen Pharms
ORTHO-NOVUM 7/7/7-28
ethinyl estradiol; norethindrone
TABLET;ORAL-28018985-002Apr 4, 19844,530,839► subscribe
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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 data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. 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.

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