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Generated: October 22, 2017

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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 Barr, Novast Labs Ltd, Watson Labs, Lupin Ltd, Mylan Labs Ltd, Sandoz Inc, Vintage Pharms Llc, Glenmark Generics, Lupin Pharms, Janssen Pharms, Aurobindo Pharma Ltd, Glenmark Pharms, Amneal Pharms, Oc Pharma, Barr Labs Inc, and Sandoz, 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 eleven 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 Generic Name: ethinyl estradiol; norgestimate

US Patents:1
Tradenames:18
Applicants:16
NDAs:33
Drug Master File Entries: see list26
Suppliers / Packagers: see list20
Clinical Trials: see list690
Drug Prices:see low prices
DailyMed Link:ethinyl estradiol; norgestimate at DailyMed
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mylan Labs Ltd
NORGESTIMATE AND ETHINYL ESTRADIOL
ethinyl estradiol; norgestimate
TABLET;ORAL-28201896-001Jan 27, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe
Sandoz
TRI-ESTARYLLA
ethinyl estradiol; norgestimate
TABLET;ORAL-28090793-001Jan 30, 2013ABRXNoNo► Subscribe► Subscribe► Subscribe
Vintage Pharms Llc
TRI-PREVIFEM
ethinyl estradiol; norgestimate
TABLET;ORAL-28076335-001Mar 26, 2004ABRXNoNo► Subscribe► Subscribe► Subscribe
Watson Labs
NORGESTIMATE AND ETHINYL ESTRADIOL
ethinyl estradiol; norgestimate
TABLET;ORAL-28076626-001Aug 17, 2006DISCNNoNo► Subscribe► Subscribe► Subscribe
Aurobindo Pharma Ltd
TRI-LO-MILI
ethinyl estradiol; norgestimate
TABLET;ORAL-28205762-001Nov 4, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe
Vintage Pharms Llc
PREVIFEM
ethinyl estradiol; norgestimate
TABLET;ORAL-28076334-001Jan 9, 2004ABRXNoNo► Subscribe► Subscribe► Subscribe
Oc Pharma
NORGESTIMATE AND ETHINYL ESTRADIOL
ethinyl estradiol; norgestimate
TABLET;ORAL-28200384-001Apr 7, 2015ABRXNoNo► Subscribe► Subscribe► Subscribe
Amneal Pharms
NORGESTIMATE AND ETHINYL ESTRADIOL
ethinyl estradiol; norgestimate
TABLET;ORAL-28203873-001May 12, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe
Janssen Pharms
ORTHO TRI-CYCLEN
ethinyl estradiol; norgestimate
TABLET;ORAL-28019697-001Jul 3, 1992ABRXYesYes► Subscribe► Subscribe► Subscribe
Barr
TRI-SPRINTEC
ethinyl estradiol; norgestimate
TABLET;ORAL-28075808-001Dec 29, 2003ABRXNoNo► 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 Pharms
ORTHO TRI-CYCLEN
ethinyl estradiol; norgestimate
TABLET;ORAL-21019697-002Jul 3, 1992► Subscribe► Subscribe
Janssen Pharms
ORTHO TRI-CYCLEN
ethinyl estradiol; norgestimate
TABLET;ORAL-28019697-001Jul 3, 1992► Subscribe► Subscribe
Janssen Pharms
ORTHO TRI-CYCLEN LO
ethinyl estradiol; norgestimate
TABLET;ORAL-28021241-001Aug 22, 2002► Subscribe► Subscribe
Janssen Pharms
ORTHO TRI-CYCLEN
ethinyl estradiol; norgestimate
TABLET;ORAL-21019697-002Jul 3, 1992► Subscribe► Subscribe
Janssen Pharms
ORTHO TRI-CYCLEN
ethinyl estradiol; norgestimate
TABLET;ORAL-28019697-001Jul 3, 1992► Subscribe► Subscribe
Janssen Pharms
ORTHO TRI-CYCLEN
ethinyl estradiol; norgestimate
TABLET;ORAL-21019697-002Jul 3, 1992► Subscribe► Subscribe
Janssen Pharms
ORTHO TRI-CYCLEN LO
ethinyl estradiol; norgestimate
TABLET;ORAL-28021241-001Aug 22, 2002► Subscribe► Subscribe
Janssen Pharms
ORTHO TRI-CYCLEN
ethinyl estradiol; norgestimate
TABLET;ORAL-28019697-001Jul 3, 1992► Subscribe► Subscribe
Janssen Pharms
ORTHO TRI-CYCLEN LO
ethinyl estradiol; norgestimate
TABLET;ORAL-28021241-001Aug 22, 2002► Subscribe► Subscribe
Janssen Pharms
ORTHO TRI-CYCLEN
ethinyl estradiol; norgestimate
TABLET;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
Turkey200101826► Subscribe
MexicoPA02000330► Subscribe
Poland352432► Subscribe
Australia5485500► Subscribe
Slovakia8872001► Subscribe
South Africa200106006► Subscribe
Norway20013144► Subscribe
Canada2356747► Subscribe
Slovakia287931► Subscribe
Hungary0104680► 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
/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
2015000093Germany► SubscribePRODUCT NAME: LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 87675.00.00 20150720; FIRST REGISTRATION: SLOWAKEI 17/0017/15-S 20150129
0814Netherlands► SubscribePRODUCT NAME: LEVONORGESTREL EN ETHINYLESTRADIOL; NATIONAL REGISTRATION NO/DATE: RVG 117453 20151211; FIRST REGISTRATION: SK 17/0017/15-S 20150211
00221Netherlands► SubscribePRODUCT NAME: DROSPIRENON EN ETHINYLESTRADIOL; REGISTRATION NO/DATE: RVG 23827 20000307
2016 00016Denmark► SubscribePRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: SK 17/0017/15-S 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
1214076/01Switzerland► SubscribePRODUCT NAME: DROSPIRENONE + ETHINYLESTRADIOL; REGISTRATION NUMBER/DATE: SWISSMEDIC 57946 13.06.2008
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
C0001France► SubscribePRODUCT NAME: ETHINYLESTRADIOL BETADEX CLATHRATE; NAT. REGISTRATION NO/DATE: NL 32343 20060710; FIRST REGISTRATION: NL - RVG 31781 20050804
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

US Department of Justice
UBS
Baxter
Novartis
Boehringer Ingelheim
Moodys
McKinsey
McKesson
Deloitte
Citi

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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