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Ethinyl estradiol; norethindrone acetate - Generic Drug Details

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Ethinyl estradiol; norethindrone acetate is the generic ingredient in forty-four branded drugs marketed by Apil, Barr, Lupin Ltd, Barr Labs Inc, Parke Davis, Mayne Pharma, Novast Labs Ltd, Glenmark Generics, Jai Pharma Ltd, Amneal Pharms, Glenmark Pharms Ltd, Vintage Pharms Llc, Lupin Atlantis, and Vintage Pharms, and is included in forty-nine NDAs. There are three 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. Twenty suppliers are listed for this compound.

Summary for Generic Name: ethinyl estradiol; norethindrone acetate

Tradenames:44
Patents:3
Applicants:14
NDAs:49
Drug Master File Entries: see list26
Suppliers / Packagers: see list20
Clinical Trials: see list660
Formulation / Manufacturing:see details
Drug Prices:see low prices

Pharmacology for Ingredient: ethinyl estradiol; norethindrone acetate

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Lupin Ltd
BLISOVI 24 FE
ethinyl estradiol; norethindrone acetate
TABLET;ORAL091398-001Oct 28, 2015RXNo► subscribe► subscribe
Lupin Atlantis
MIBELAS 24 FE
ethinyl estradiol; norethindrone acetate
TABLET, CHEWABLE;ORAL206287-001May 24, 2016RXNo► subscribe► subscribe
Parke Davis
NORLESTRIN 21 2.5/50
ethinyl estradiol; norethindrone acetate
TABLET;ORAL-21016852-001Approved Prior to Jan 1, 1982DISCNNo► subscribe► subscribe
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Expired Orange Book Patents for Generic Ingredient: ethinyl estradiol; norethindrone acetate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Apil
ESTROSTEP 21
ethinyl estradiol; norethindrone acetate
TABLET;ORAL-21020130-001Oct 9, 19965,010,070► subscribe
Apil
FEMHRT
ethinyl estradiol; norethindrone acetate
TABLET;ORAL021065-001Jan 14, 20055,208,225► subscribe
Apil
TAYTULLA
ethinyl estradiol; norethindrone acetate
CAPSULE;ORAL204426-001Apr 19, 20135,552,394► subscribe
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International Patent Family for Ingredient: ethinyl estradiol; norethindrone acetate

Country Document Number Estimated Expiration
Austria311177► subscribe
Brazil0009373► subscribe
Slovenia1173153► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: ETHINYL ESTRADIOL; NORETHINDRONE ACETATE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2006 00038Denmark► subscribePRODUCT NAME: ETHINYLESTRADIOL (SOM BETA-CYCLODEXTRIN-CLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 38687 20060627; FIRST REG. NO/DATE: EU RVG 31781 20050804
1214076/01Switzerland► subscribePRODUCT NAME: DROSPIRENONE + ETHINYLESTRADIOL; REGISTRATION NUMBER/DATE: SWISSMEDIC 57946 13.06.2008
2009 00017Denmark► subscribePRODUCT NAME: ETHINYLESTRADIOL (SOM BETADEXCLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 42417 (DK) 20080619; FIRST REG. NO/DATE: NL 33842 20070629
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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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