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Ethinyl estradiol; norgestimate - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for ethinyl estradiol; norgestimate?

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, Haupt Pharma, 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.

This ingredient has forty-three patent family members in twenty-five countries.

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

Summary for Generic Name: ethinyl estradiol; norgestimate

Tradenames:18
Patents:2
Applicants:17
NDAs:33
Drug Master File Entries: see list26
Suppliers / Packagers: see list22
Clinical Trials: see list260
Drug Prices:see low prices
DailyMed Link:ethinyl estradiol; norgestimate at DailyMed
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Glenmark Pharms
NORGESTIMATE AND ETHINYL ESTRADIOL
ethinyl estradiol; norgestimate
TABLET;ORAL-28204057-001Feb 23, 2016RXNoNo► Subscribe► Subscribe
Janssen Pharms
ORTHO CYCLEN-28
ethinyl estradiol; norgestimate
TABLET;ORAL-28019653-002Dec 29, 1989RXYesYes► Subscribe► Subscribe
Novast Labs Ltd
TRI-LINYAH
ethinyl estradiol; norgestimate
TABLET;ORAL-28090524-001May 30, 2012RXNoNo► Subscribe► Subscribe
Janssen Pharms
ORTHO CYCLEN-21
ethinyl estradiol; norgestimate
TABLET;ORAL-21019653-001Dec 29, 1989DISCNNoNo► Subscribe► Subscribe
Mylan Labs Ltd
NORGESTIMATE AND ETHINYL ESTRADIOL
ethinyl estradiol; norgestimate
TABLET;ORAL-28201896-001Jan 27, 2016RXNoNo► 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-28019697-001Jul 3, 19924,544,554*PED► Subscribe
Janssen Pharms
ORTHO TRI-CYCLEN
ethinyl estradiol; norgestimate
TABLET;ORAL-21019697-002Jul 3, 19924,027,019► Subscribe
Janssen Pharms
ORTHO TRI-CYCLEN
ethinyl estradiol; norgestimate
TABLET;ORAL-21019697-002Jul 3, 19924,628,051► Subscribe
Janssen Pharms
ORTHO TRI-CYCLEN LO
ethinyl estradiol; norgestimate
TABLET;ORAL-28021241-001Aug 22, 20024,628,051*PED► Subscribe
Janssen Pharms
ORTHO TRI-CYCLEN
ethinyl estradiol; norgestimate
TABLET;ORAL-28019697-001Jul 3, 19924,027,019► 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
Canada2356747► Subscribe
Russian Federation2225207► Subscribe
Hungary0202249► Subscribe
Taiwan589311► Subscribe
Australia1936500► 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
2009 00017Denmark► SubscribePRODUCT NAME: ETHINYLESTRADIOL (SOM BETADEXCLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 42417 (DK) 20080619; FIRST REG. NO/DATE: NL 33842 20070629
1214076/01Switzerland► SubscribePRODUCT NAME: DROSPIRENONE + ETHINYLESTRADIOL; REGISTRATION NUMBER/DATE: SWISSMEDIC 57946 13.06.2008
00C/027Belgium► SubscribePRODUCT NAME: ETHINYLESTRADIOLUM / NORETHISTERONI ACETAS; NAT. REGISTRATION NO/DATE: 19 IS 106 F3 20000911; FIRST REGISTRATION: NL RVG 23909 19991124
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
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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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