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Generated: February 21, 2018

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, Labs Leon Farma, 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, and Barr Labs 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.

There are twenty-six drug master file entries for ethinyl estradiol; norgestimate. Twenty-one suppliers are listed for this compound.
Summary for ethinyl estradiol; norgestimate
International Patents:46
US Patents:1
Tradenames:18
Applicants:15
NDAs:33
Drug Master File Entries: 26
Suppliers / Packagers: 21
Clinical Trials: 699
Drug Prices:see low prices
DailyMed Link:ethinyl estradiol; norgestimate at DailyMed

US Patents and Regulatory Information for ethinyl estradiol; norgestimate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Oc Pharma NORGESTIMATE AND ETHINYL ESTRADIOL ethinyl estradiol; norgestimate TABLET;ORAL-28 200383-001 Apr 7, 2015 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Aurobindo Pharma Ltd TRI-MILI ethinyl estradiol; norgestimate TABLET;ORAL-28 205441-001 Jul 6, 2016 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Barr SPRINTEC ethinyl estradiol; norgestimate TABLET;ORAL-28 075804-001 Sep 25, 2002 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Labs Leon Farma ESTARYLLA ethinyl estradiol; norgestimate TABLET;ORAL-28 090794-001 Jan 30, 2013 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Mylan Labs Ltd NORGESTIMATE AND ETHINYL ESTRADIOL ethinyl estradiol; norgestimate TABLET;ORAL-28 201897-001 Jan 27, 2016 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Aurobindo Pharma Ltd TRI-LO-MILI ethinyl estradiol; norgestimate TABLET;ORAL-28 205762-001 Nov 4, 2016 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Novast Labs Ltd TRI-LINYAH ethinyl estradiol; norgestimate TABLET;ORAL-28 090524-001 May 30, 2012 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Janssen Pharms ORTHO TRI-CYCLEN ethinyl estradiol; norgestimate TABLET;ORAL-21 019697-002 Jul 3, 1992 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Novast Labs Ltd MONO-LINYAH ethinyl estradiol; norgestimate TABLET;ORAL-28 090523-001 May 23, 2012 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Amneal Pharms NORGESTIMATE AND ETHINYL ESTRADIOL ethinyl estradiol; norgestimate TABLET;ORAL-28 203870-001 Nov 12, 2015 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for ethinyl estradiol; norgestimate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Pharms ORTHO TRI-CYCLEN LO ethinyl estradiol; norgestimate TABLET;ORAL-28 021241-001 Aug 22, 2002 ➤ Sign Up ➤ Sign Up
Janssen Pharms ORTHO TRI-CYCLEN ethinyl estradiol; norgestimate TABLET;ORAL-21 019697-002 Jul 3, 1992 ➤ Sign Up ➤ Sign Up
Janssen Pharms ORTHO TRI-CYCLEN ethinyl estradiol; norgestimate TABLET;ORAL-21 019697-002 Jul 3, 1992 ➤ Sign Up ➤ Sign Up
Janssen Pharms ORTHO TRI-CYCLEN ethinyl estradiol; norgestimate TABLET;ORAL-28 019697-001 Jul 3, 1992 ➤ Sign Up ➤ Sign Up
Janssen Pharms ORTHO TRI-CYCLEN LO ethinyl estradiol; norgestimate TABLET;ORAL-28 021241-001 Aug 22, 2002 ➤ Sign Up ➤ Sign Up
Janssen Pharms ORTHO TRI-CYCLEN ethinyl estradiol; norgestimate TABLET;ORAL-21 019697-002 Jul 3, 1992 ➤ Sign Up ➤ Sign Up
Janssen Pharms ORTHO TRI-CYCLEN ethinyl estradiol; norgestimate TABLET;ORAL-28 019697-001 Jul 3, 1992 ➤ Sign Up ➤ Sign Up
Janssen Pharms ORTHO TRI-CYCLEN ethinyl estradiol; norgestimate TABLET;ORAL-28 019697-001 Jul 3, 1992 ➤ Sign Up ➤ Sign Up
Janssen Pharms ORTHO TRI-CYCLEN ethinyl estradiol; norgestimate TABLET;ORAL-28 019697-001 Jul 3, 1992 ➤ Sign Up ➤ Sign Up
Janssen Pharms ORTHO TRI-CYCLEN ethinyl estradiol; norgestimate TABLET;ORAL-28 019697-001 Jul 3, 1992 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for 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 ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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International Patents for ethinyl estradiol; norgestimate

Supplementary Protection Certificates for ethinyl estradiol; norgestimate

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2009 00017 Denmark ➤ Sign Up PRODUCT NAME: ETHINYLESTRADIOL (SOM BETADEXCLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 42417 (DK) 20080619; FIRST REG. NO/DATE: NL 33842 20070629
1214076/01 Switzerland ➤ Sign Up PRODUCT NAME: DROSPIRENONE + ETHINYLESTRADIOL; REGISTRATION NUMBER/DATE: SWISSMEDIC 57946 13.06.2008
2006 00038 Denmark ➤ Sign Up PRODUCT NAME: ETHINYLESTRADIOL (SOM BETA-CYCLODEXTRIN-CLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 38687 20060627; FIRST REG. NO/DATE: EU RVG 31781 20050804
C0001 France ➤ Sign Up PRODUCT NAME: ETHINYLESTRADIOL BETADEX CLATHRATE; NAT. REGISTRATION NO/DATE: NL 32343 20060710; FIRST REGISTRATION: NL - RVG 31781 20050804
00221 Netherlands ➤ Sign Up PRODUCT NAME: DROSPIRENON EN ETHINYLESTRADIOL; REGISTRATION NO/DATE: RVG 23827 20000307
2015000093 Germany ➤ Sign Up PRODUCT NAME: LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 87675.00.00 20150720; FIRST REGISTRATION: SLOWAKEI 17/0017/15-S 20150129
0814 Netherlands ➤ Sign Up PRODUCT NAME: LEVONORGESTREL EN ETHINYLESTRADIOL; NATIONAL REGISTRATION NO/DATE: RVG 117453 20151211; FIRST REGISTRATION: SK 17/0017/15-S 20150211
156 Luxembourg ➤ Sign Up PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211
/2015 Austria ➤ Sign Up PRODUCT NAME: ETHINYLESTRADIOL UND EINE KOMBINATION VON LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 136021 20150224; FIRST REGISTRATION: SK 17/0017/15-S 20150211
2016 00016 Denmark ➤ Sign Up PRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: SK 17/0017/15-S 20150211
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Deloitte
Accenture
Moodys
UBS
McKinsey
Boehringer Ingelheim
Chinese Patent Office
US Department of Justice
Chubb

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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