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Generated: October 24, 2017

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Ethinyl estradiol; norethindrone acetate - Generic Drug Details

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

Ethinyl estradiol; norethindrone acetate
is the generic ingredient in forty-nine branded drugs marketed by Apil, Aurobindo Pharma Ltd, Barr, Lupin Ltd, Amneal Pharms, Mylan Labs Ltd, Barr Labs Inc, Parke Davis, Mayne Pharma, Novast Labs Ltd, Glenmark Generics, Glenmark Pharms Ltd, Vintage Pharms Llc, Lupin Atlantis, and Vintage Pharms, and is included in fifty-seven NDAs. There are three patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Ethinyl estradiol; norethindrone acetate has forty patent family members in twenty-four countries and eleven supplementary protection certificates in eight countries.

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

Summary for Generic Name: ethinyl estradiol; norethindrone acetate

US Patents:3
Tradenames:49
Applicants:15
NDAs:57
Drug Master File Entries: see list26
Suppliers / Packagers: see list23
Clinical Trials: see list1,538
Drug Prices:see low prices
DailyMed Link:ethinyl estradiol; norethindrone acetate at DailyMed

Pharmacology for Ingredient: ethinyl estradiol; norethindrone acetate

Tentative approvals for ETHINYL ESTRADIOL; NORETHINDRONE ACETATE

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
Barr
JUNEL FE 1/20
ethinyl estradiol; norethindrone acetate
TABLET;ORAL-28076081-001Sep 18, 2003ABRXNoNo► Subscribe► Subscribe► Subscribe
Vintage Pharms Llc
GILDESS FE 1/20
ethinyl estradiol; norethindrone acetate
TABLET;ORAL-28077077-001May 20, 2005ABRXNoNo► Subscribe► Subscribe► Subscribe
Lupin Ltd
FYAVOLV
ethinyl estradiol; norethindrone acetate
TABLET;ORAL204213-001Dec 10, 2015ABRXNoNo► Subscribe► Subscribe► Subscribe
Glenmark Generics
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL
ethinyl estradiol; norethindrone acetate
TABLET;ORAL203038-001Apr 2, 2015ABRXNoNo► Subscribe► Subscribe► Subscribe
Apil
FEMHRT
ethinyl estradiol; norethindrone acetate
TABLET;ORAL021065-001Jan 14, 2005ABRXNoNo► Subscribe► Subscribe► Subscribe
Mylan Labs Ltd
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL
ethinyl estradiol; norethindrone acetate
TABLET;ORAL207259-001Dec 27, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe
Amneal Pharms
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE
ethinyl estradiol; norethindrone acetate
TABLET, CHEWABLE;ORAL207514-001Sep 11, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe
Novast Labs Ltd
LARIN 1/20
ethinyl estradiol; norethindrone acetate
TABLET;ORAL-21202995-001Dec 4, 2013ABRXNoNo► Subscribe► Subscribe► Subscribe
Mylan Labs Ltd
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE
ethinyl estradiol; norethindrone acetate
TABLET;ORAL202742-001Oct 30, 2014ABRXNoNo► Subscribe► Subscribe► Subscribe
Glenmark Pharms Ltd
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL
ethinyl estradiol; norethindrone acetate
TABLET;ORAL-21206969-001Jan 20, 2016ABRXNoNo► Subscribe► 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
LO LOESTRIN FE
ethinyl estradiol; norethindrone acetate
TABLET;ORAL022501-001Oct 21, 2010► Subscribe► Subscribe
Apil
FEMHRT
ethinyl estradiol; norethindrone acetate
TABLET;ORAL021065-002Oct 15, 1999► Subscribe► Subscribe
Apil
LO MINASTRIN FE
ethinyl estradiol; norethindrone acetate
TABLET, CHEWABLE, TABLET;ORAL204654-001Jul 24, 2013► Subscribe► Subscribe
Apil
LOESTRIN 24 FE
ethinyl estradiol; norethindrone acetate
TABLET;ORAL021871-001Feb 17, 2006► Subscribe► Subscribe
Apil
ESTROSTEP FE
ethinyl estradiol; norethindrone acetate
TABLET;ORAL-28020130-002Oct 9, 1996► Subscribe► Subscribe
Apil
MINASTRIN 24 FE
ethinyl estradiol; norethindrone acetate
TABLET, CHEWABLE;ORAL203667-001May 8, 2013► Subscribe► Subscribe
Apil
ESTROSTEP 21
ethinyl estradiol; norethindrone acetate
TABLET;ORAL-21020130-001Oct 9, 1996► Subscribe► Subscribe
Apil
ESTROSTEP FE
ethinyl estradiol; norethindrone acetate
TABLET;ORAL-28020130-002Oct 9, 1996► Subscribe► Subscribe
Apil
TAYTULLA
ethinyl estradiol; norethindrone acetate
CAPSULE;ORAL204426-001Apr 19, 2013► Subscribe► Subscribe
Apil
ESTROSTEP 21
ethinyl estradiol; norethindrone acetate
TABLET;ORAL-21020130-001Oct 9, 1996► Subscribe► Subscribe
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International Patent Family for Ingredient: ethinyl estradiol; norethindrone acetate

Country Document Number Estimated Expiration
MexicoPA01009817► Subscribe
European Patent Office1173153► Subscribe
China104248639► Subscribe
World Intellectual Property Organization (WIPO)0059482► Subscribe
Japan4636692► Subscribe
Germany60024429► Subscribe
Israel186656► Subscribe
Spain2251991► Subscribe
Turkey200102861► 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
2016 00016Denmark► SubscribePRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: SK 17/0017/15-S 20150211
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
/2015Austria► SubscribePRODUCT NAME: ETHINYLESTRADIOL UND EINE KOMBINATION VON LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 136021 20150224; 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
0814Netherlands► SubscribePRODUCT NAME: LEVONORGESTREL EN ETHINYLESTRADIOL; NATIONAL REGISTRATION NO/DATE: RVG 117453 20151211; FIRST REGISTRATION: SK 17/0017/15-S 20150211
C0001France► SubscribePRODUCT NAME: ETHINYLESTRADIOL BETADEX CLATHRATE; NAT. REGISTRATION NO/DATE: NL 32343 20060710; FIRST REGISTRATION: NL - RVG 31781 20050804
1214076/01Switzerland► SubscribePRODUCT NAME: DROSPIRENONE + ETHINYLESTRADIOL; REGISTRATION NUMBER/DATE: SWISSMEDIC 57946 13.06.2008
2015000093Germany► SubscribePRODUCT NAME: LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 87675.00.00 20150720; FIRST REGISTRATION: SLOWAKEI 17/0017/15-S 20150129
00221Netherlands► SubscribePRODUCT NAME: DROSPIRENON EN ETHINYLESTRADIOL; REGISTRATION NO/DATE: RVG 23827 20000307
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

UBS
Farmers Insurance
Medtronic
McKesson
Moodys
Cantor Fitzgerald
Healthtrust
Accenture
Express Scripts
Julphar

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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