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Serving leading biopharmaceutical companies globally:

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Generated: December 12, 2017

DrugPatentWatch Database Preview

Ethinyl estradiol; norgestimate - Generic Drug Details

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What are the generic sources for ethinyl estradiol; norgestimate and what is the scope of ethinyl estradiol; norgestimate patent protection?

Ethinyl estradiol; norgestimate
is the generic ingredient in eighteen branded drugs marketed by Glenmark Generics, Janssen Pharms, Sandoz, Aurobindo Pharma Ltd, Novast Labs Ltd, Amneal Pharms, Glenmark Pharms, Lupin Ltd, Lupin Pharms, Mylan Labs Ltd, Oc Pharma, Watson Labs, Vintage Pharms Llc, Barr, Barr Labs Inc, and Sandoz Inc, and is included in thirty-three NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Ethinyl estradiol; norgestimate has forty-six patent family members in twenty-six countries and twelve supplementary protection certificates in eight countries.

There are twenty-six drug master file entries for ethinyl estradiol; norgestimate. Twenty suppliers are listed for this compound.

Summary for ethinyl estradiol; norgestimate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Novast Labs LtdMONO-LINYAHethinyl estradiol; norgestimateTABLET;ORAL-28090523-001May 23, 2012ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Janssen PharmsORTHO CYCLEN-28ethinyl estradiol; norgestimateTABLET;ORAL-28019653-002Dec 29, 1989ABRXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Vintage Pharms LlcTRI-PREVIFEMethinyl estradiol; norgestimateTABLET;ORAL-28076335-001Mar 26, 2004ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Janssen PharmsORTHO CYCLEN-21ethinyl estradiol; norgestimateTABLET;ORAL-21019653-001Dec 29, 1989DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Barr Labs IncTRI LO SPRINTECethinyl estradiol; norgestimateTABLET;ORAL-28076784-001Jun 29, 2009ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Amneal PharmsNORGESTIMATE AND ETHINYL ESTRADIOLethinyl estradiol; norgestimateTABLET;ORAL-28203873-001May 12, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
BarrSPRINTECethinyl estradiol; norgestimateTABLET;ORAL-28075804-001Sep 25, 2002ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Janssen PharmsORTHO TRI-CYCLENethinyl estradiol; norgestimateTABLET;ORAL-21019697-002Jul 3, 1992DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
SandozTRI-ESTARYLLAethinyl estradiol; norgestimateTABLET;ORAL-28090793-001Jan 30, 2013ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Aurobindo Pharma LtdTRI-LO-MILIethinyl estradiol; norgestimateTABLET;ORAL-28205762-001Nov 4, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: ethinyl estradiol; norgestimate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen PharmsORTHO TRI-CYCLENethinyl estradiol; norgestimateTABLET;ORAL-28019697-001Jul 3, 1992► Subscribe► Subscribe
Janssen PharmsORTHO TRI-CYCLEN LOethinyl estradiol; norgestimateTABLET;ORAL-28021241-001Aug 22, 2002► Subscribe► Subscribe
Janssen PharmsORTHO TRI-CYCLENethinyl estradiol; norgestimateTABLET;ORAL-21019697-002Jul 3, 1992► Subscribe► Subscribe
Janssen PharmsORTHO TRI-CYCLENethinyl estradiol; norgestimateTABLET;ORAL-28019697-001Jul 3, 1992► Subscribe► Subscribe
Janssen PharmsORTHO TRI-CYCLEN LOethinyl estradiol; norgestimateTABLET;ORAL-28021241-001Aug 22, 2002► Subscribe► Subscribe
Janssen PharmsORTHO TRI-CYCLENethinyl estradiol; norgestimateTABLET;ORAL-28019697-001Jul 3, 1992► Subscribe► Subscribe
Janssen PharmsORTHO TRI-CYCLENethinyl estradiol; norgestimateTABLET;ORAL-28019697-001Jul 3, 1992► Subscribe► Subscribe
Janssen PharmsORTHO TRI-CYCLENethinyl estradiol; norgestimateTABLET;ORAL-21019697-002Jul 3, 1992► Subscribe► Subscribe
Janssen PharmsORTHO TRI-CYCLENethinyl estradiol; norgestimateTABLET;ORAL-28019697-001Jul 3, 1992► Subscribe► Subscribe
Janssen PharmsORTHO TRI-CYCLENethinyl estradiol; norgestimateTABLET;ORAL-21019697-002Jul 3, 1992► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: ethinyl estradiol; norgestimate

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
6,809,107 Neurotrophic pyrrolidines and piperidines, and related compositions and methods► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: ethinyl estradiol; norgestimate

Country Document Number Estimated Expiration
World Intellectual Property Organization (WIPO)0038691► Subscribe
Australia765153► Subscribe
Russian Federation2241709► Subscribe
Japan2003504367► Subscribe
Argentina034541► Subscribe
Portugal1140109► Subscribe
Hungary0202249► Subscribe
Slovakia8872001► Subscribe
Brazil9916579► Subscribe
Austria318605► 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; NORGESTIMATE

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
00221Netherlands► SubscribePRODUCT NAME: DROSPIRENON EN ETHINYLESTRADIOL; REGISTRATION NO/DATE: RVG 23827 20000307
156Luxembourg► SubscribePRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211
1214076/01Switzerland► SubscribePRODUCT NAME: DROSPIRENONE + ETHINYLESTRADIOL; REGISTRATION NUMBER/DATE: SWISSMEDIC 57946 13.06.2008
49/2008Austria► SubscribePRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON
00C/027Belgium► SubscribePRODUCT NAME: ETHINYLESTRADIOLUM / NORETHISTERONI ACETAS; NAT. REGISTRATION NO/DATE: 19 IS 106 F3 20000911; FIRST REGISTRATION: NL RVG 23909 19991124
2009 00017Denmark► SubscribePRODUCT NAME: ETHINYLESTRADIOL (SOM BETADEXCLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 42417 (DK) 20080619; FIRST REG. NO/DATE: NL 33842 20070629
2016 00016Denmark► SubscribePRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: 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
/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
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Serving leading biopharmaceutical companies globally:

Deloitte
Dow
Harvard Business School
Federal Trade Commission
Daiichi Sankyo
Baxter
Queensland Health
Covington
Colorcon
Mallinckrodt

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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