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Argus Health
Daiichi Sankyo
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Farmers Insurance
Harvard Business School
Federal Trade Commission
McKesson
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Generated: October 18, 2017

DrugPatentWatch Database Preview

Ethinyl estradiol; norethindrone acetate - Generic Drug Details

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What are the generic drug 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-four 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 list24
Clinical Trials: see list1,523
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
Aurobindo Pharma Ltd
AUROVELA 1.5/30
ethinyl estradiol; norethindrone acetate
TABLET;ORAL-21207581-001Jun 26, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe
Mylan Labs Ltd
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL
ethinyl estradiol; norethindrone acetate
TABLET;ORAL207260-001Feb 2, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe
Barr
JUNEL FE 1/20
ethinyl estradiol; norethindrone acetate
TABLET;ORAL-28076081-001Sep 18, 2003ABRXNoNo► Subscribe► Subscribe► Subscribe
Mylan Labs Ltd
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE
ethinyl estradiol; norethindrone acetate
TABLET, CHEWABLE;ORAL206120-001Sep 12, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe
Lupin Ltd
FYAVOLV
ethinyl estradiol; norethindrone acetate
TABLET;ORAL204213-001Dec 10, 2015ABRXNoNo► Subscribe► Subscribe► Subscribe
Novast Labs Ltd
LARIN 1.5/30
ethinyl estradiol; norethindrone acetate
TABLET;ORAL-21202996-001Mar 20, 2014ABRXNoNo► Subscribe► Subscribe► Subscribe
Apil
LOESTRIN 21 1.5/30
ethinyl estradiol; norethindrone acetate
TABLET;ORAL-21017875-001Approved Prior to Jan 1, 1982ABRXNoNo► Subscribe► Subscribe► Subscribe
Apil
LO MINASTRIN FE
ethinyl estradiol; norethindrone acetate
TABLET, CHEWABLE, TABLET;ORAL204654-001Jul 24, 2013RXYesYes► Subscribe► SubscribeY ► Subscribe
Novast Labs Ltd
LARIN 24 FE
ethinyl estradiol; norethindrone acetate
TABLET;ORAL202994-001Feb 18, 2015ABRXNoNo► Subscribe► Subscribe► Subscribe
Apil
ESTROSTEP 21
ethinyl estradiol; norethindrone acetate
TABLET;ORAL-21020130-001Oct 9, 1996DISCNYesNo► Subscribe► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: ethinyl estradiol; norethindrone acetate

International Patent Family for Ingredient: ethinyl estradiol; norethindrone acetate

Country Document Number Estimated Expiration
South Africa200108457► Subscribe
Japan2003526620► Subscribe
MexicoPA01009817► Subscribe
Australia4049400► Subscribe
World Intellectual Property Organization (WIPO)0059482► Subscribe
United Kingdom9907715► Subscribe
World Intellectual Property Organization (WIPO)2006115871► Subscribe
China101189015► Subscribe
Czech Republic20013460► Subscribe
Poland196823► 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
0814Netherlands► SubscribePRODUCT NAME: LEVONORGESTREL EN ETHINYLESTRADIOL; NATIONAL REGISTRATION NO/DATE: RVG 117453 20151211; FIRST REGISTRATION: SK 17/0017/15-S 20150211
2016 00016Denmark► SubscribePRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: SK 17/0017/15-S 20150211
00221Netherlands► SubscribePRODUCT NAME: DROSPIRENON EN ETHINYLESTRADIOL; REGISTRATION NO/DATE: RVG 23827 20000307
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
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
2009 00017Denmark► SubscribePRODUCT NAME: ETHINYLESTRADIOL (SOM BETADEXCLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 42417 (DK) 20080619; FIRST REG. NO/DATE: NL 33842 20070629
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
156Luxembourg► SubscribePRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211
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Serving leading biopharmaceutical companies globally:

US Department of Justice
Citi
AstraZeneca
McKinsey
US Army
Boehringer Ingelheim
Moodys
Teva
Deloitte
Cantor Fitzgerald

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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