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Ethinyl estradiol; norethindrone acetate - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for ethinyl estradiol; norethindrone acetate?

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, Mylan Labs Ltd, Amneal Pharms, Glenmark Pharms Ltd, Vintage Pharms Llc, Lupin Atlantis, and Vintage Pharms, and is included in fifty 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-one suppliers are listed for this compound.

Summary for Generic Name: ethinyl estradiol; norethindrone acetate

Tradenames:44
Patents:4
Applicants:14
NDAs:50
Drug Master File Entries: see list26
Suppliers / Packagers: see list21
Clinical Trials: see list660
Drug Prices:see low prices
DailyMed Link:ethinyl estradiol; norethindrone acetate at DailyMed

Pharmacology for Ingredient: ethinyl estradiol; norethindrone acetate

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Apil
LOESTRIN 21 1.5/30
ethinyl estradiol; norethindrone acetate
TABLET;ORAL-21017875-001Approved Prior to Jan 1, 1982RXNoNo► Subscribe► Subscribe
Mayne Pharma
MICROGESTIN 1.5/30
ethinyl estradiol; norethindrone acetate
TABLET;ORAL-21075548-002Jul 30, 2003RXNoNo► Subscribe► Subscribe
Novast Labs Ltd
LARIN 1/20
ethinyl estradiol; norethindrone acetate
TABLET;ORAL-21202995-001Dec 4, 2013RXNoNo► Subscribe► Subscribe
Vintage Pharms Llc
GILDESS 1/20
ethinyl estradiol; norethindrone acetate
TABLET;ORAL-21077077-002Jul 24, 2012RXNoNo► Subscribe► Subscribe
Mylan Labs Ltd
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL
ethinyl estradiol; norethindrone acetate
TABLET;ORAL-28202741-001Feb 20, 2015RXNoNo► 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
TAYTULLA
ethinyl estradiol; norethindrone acetate
CAPSULE;ORAL204426-001Apr 19, 20135,552,394► Subscribe
Apil
FEMHRT
ethinyl estradiol; norethindrone acetate
TABLET;ORAL021065-001Jan 14, 20055,208,225► Subscribe
Apil
ESTROSTEP 21
ethinyl estradiol; norethindrone acetate
TABLET;ORAL-21020130-001Oct 9, 19965,010,070► Subscribe
Apil
ESTROSTEP FE
ethinyl estradiol; norethindrone acetate
TABLET;ORAL-28020130-002Oct 9, 19964,962,098► Subscribe
Apil
ESTROSTEP FE
ethinyl estradiol; norethindrone acetate
TABLET;ORAL-28020130-002Oct 9, 19965,010,070► Subscribe
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International Patent Family for Ingredient: ethinyl estradiol; norethindrone acetate

Country Document Number Estimated Expiration
Israel186656► Subscribe
Japan4636692► Subscribe
Hungary227155► Subscribe
European Patent Office1877062► Subscribe
Russian Federation2207859► 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
156Luxembourg► SubscribePRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211
00C/027Belgium► SubscribePRODUCT NAME: ETHINYLESTRADIOLUM / NORETHISTERONI ACETAS; NAT. REGISTRATION NO/DATE: 19 IS 106 F3 20000911; FIRST REGISTRATION: NL RVG 23909 19991124
0814Netherlands► SubscribePRODUCT NAME: LEVONORGESTREL EN ETHINYLESTRADIOL; NATIONAL REGISTRATION NO/DATE: RVG 117453 20151211; FIRST REGISTRATION: SK 17/0017/15-S 20150211
2009 00017Denmark► SubscribePRODUCT NAME: ETHINYLESTRADIOL (SOM BETADEXCLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 42417 (DK) 20080619; FIRST REG. NO/DATE: NL 33842 20070629
C0001France► SubscribePRODUCT NAME: ETHINYLESTRADIOL BETADEX CLATHRATE; NAT. REGISTRATION NO/DATE: NL 32343 20060710; FIRST REGISTRATION: NL - RVG 31781 20050804
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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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