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Serving 500+ biopharmaceutical companies globally:

Deloitte
Julphar
Novartis
Medtronic
Dow
Citi
Johnson and Johnson
Accenture
Merck
Chinese Patent Office

Generated: August 17, 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, 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-five 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 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. There are two tentative approvals for this compound.

Summary for Generic Name: ethinyl estradiol; norethindrone acetate

Tradenames:49
Patents:3
Applicants:15
NDAs:55
Drug Master File Entries: see list26
Suppliers / Packagers: see list21
Clinical Trials: see list1,505
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
► Subscribe► Subscribe0.02MG;1MGTABLET, CHEWABLE;ORAL
► Subscribe► Subscribe0.01MG,0.01MG;1MG,N/ATABLET;ORAL

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 FE
ethinyl estradiol; norethindrone acetate
TABLET;ORAL-28020130-002Oct 9, 1996► Subscribe► Subscribe
Apil
LO LOESTRIN FE
ethinyl estradiol; norethindrone acetate
TABLET;ORAL022501-001Oct 21, 2010► Subscribe► Subscribe
Apil
LO MINASTRIN FE
ethinyl estradiol; norethindrone acetate
TABLET, CHEWABLE, TABLET;ORAL204654-001Jul 24, 2013► 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
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International Patent Family for Ingredient: ethinyl estradiol; norethindrone acetate

Country Document Number Estimated Expiration
Japan4636692► Subscribe
European Patent Office1173153► Subscribe
Norway20014719► Subscribe
Denmark1173153► Subscribe
World Intellectual Property Organization (WIPO)2006115871► 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
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
00C/027Belgium► SubscribePRODUCT NAME: ETHINYLESTRADIOLUM / NORETHISTERONI ACETAS; NAT. REGISTRATION NO/DATE: 19 IS 106 F3 20000911; FIRST REGISTRATION: NL RVG 23909 19991124
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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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Dow
Deloitte
Fish and Richardson
Boehringer Ingelheim
McKinsey
Argus Health
Cantor Fitzgerald
Express Scripts
AstraZeneca
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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