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Generated: October 23, 2017

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Ethinyl estradiol; levonorgestrel - Generic Drug Details

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

Ethinyl estradiol; levonorgestrel
is the generic ingredient in forty-five branded drugs marketed by Watson Labs, Sandoz, Vintage Pharms Llc, Barr, Mayne Pharma, Labs Leon Farma, Lupin Ltd, Amneal Pharms, Duramed Pharms Barr, Novast Labs Ltd, Teva Branded Pharm, Mylan Labs Ltd, Aurobindo Pharma Ltd, Glenmark Generics, Bayer Hlthcare, Glenmark Pharms Ltd, Wyeth Pharms Inc, Wyeth Pharms, and Sandoz Inc, and is included in sixty-one NDAs. There are ten patents protecting this compound and five Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Ethinyl estradiol; levonorgestrel has one hundred and fourteen patent family members in twenty-eight countries and twelve supplementary protection certificates in nine countries.

There are twenty-six drug master file entries for ethinyl estradiol; levonorgestrel. Twenty-six suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for Generic Name: ethinyl estradiol; levonorgestrel

US Patents:10
Tradenames:45
Applicants:19
NDAs:61
Drug Master File Entries: see list26
Suppliers / Packagers: see list26
Clinical Trials: see list811
Drug Prices:see low prices
DailyMed Link:ethinyl estradiol; levonorgestrel at DailyMed

Pharmacology for Ingredient: ethinyl estradiol; levonorgestrel

Tentative approvals for ETHINYL ESTRADIOL; LEVONORGESTREL

Applicant Application No. Strength Dosage Form
u► Subscribe0.03MG,0.01MG; 0.15MG,N/ATABLET;ORAL
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
LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL
ethinyl estradiol; levonorgestrel
TABLET;ORAL206053-001Oct 2, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe
Teva Branded Pharm
SEASONIQUE
ethinyl estradiol; levonorgestrel
TABLET;ORAL021840-001May 25, 2006ABRXYesYes► Subscribe► Subscribe ► Subscribe
Teva Branded Pharm
SEASONIQUE
ethinyl estradiol; levonorgestrel
TABLET;ORAL021840-001May 25, 2006ABRXYesYes► Subscribe► SubscribeY ► Subscribe
Labs Leon Farma
ELIFEMME
ethinyl estradiol; levonorgestrel
TABLET;ORAL-28202507-001Dec 4, 2015ABRXNoNo► Subscribe► Subscribe► Subscribe
Vintage Pharms Llc
MYZILRA
ethinyl estradiol; levonorgestrel
TABLET;ORAL-28077502-001Nov 23, 2011ABRXNoNo► Subscribe► Subscribe► Subscribe
Watson Labs
LEVORA 0.15/30-21
ethinyl estradiol; levonorgestrel
TABLET;ORAL-21073592-001Dec 13, 1993DISCNNoNo► Subscribe► Subscribe► Subscribe
Duramed Pharms Barr
AVIANE-21
ethinyl estradiol; levonorgestrel
TABLET;ORAL-21075796-002Apr 30, 2001DISCNNoNo► Subscribe► Subscribe► Subscribe
Wyeth Pharms
TRIPHASIL-21
ethinyl estradiol; levonorgestrel
TABLET;ORAL-21019192-001Nov 1, 1984DISCNYesNo► Subscribe► Subscribe► Subscribe
Bayer Hlthcare
LEVLITE
ethinyl estradiol; levonorgestrel
TABLET;ORAL-21020860-001Jul 13, 1998DISCNYesNo► Subscribe► Subscribe► Subscribe
Mayne Pharma
LEVORA 0.15/30-28
ethinyl estradiol; levonorgestrel
TABLET;ORAL-28073594-001Dec 13, 1993ABRXNoYes► Subscribe► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: ethinyl estradiol; levonorgestrel

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Wyeth Pharms
TRIPHASIL-21
ethinyl estradiol; levonorgestrel
TABLET;ORAL-21019192-001Nov 1, 1984► Subscribe► Subscribe
Teva Branded Pharm
SEASONALE
ethinyl estradiol; levonorgestrel
TABLET;ORAL021544-001Sep 5, 2003► Subscribe► Subscribe
Teva Branded Pharm
NORDETTE-28
ethinyl estradiol; levonorgestrel
TABLET;ORAL-28018782-001Jul 21, 1982► Subscribe► Subscribe
Wyeth Pharms
TRIPHASIL-21
ethinyl estradiol; levonorgestrel
TABLET;ORAL-21019192-001Nov 1, 1984► Subscribe► Subscribe
Wyeth Pharms Inc
TRIPHASIL-28
ethinyl estradiol; levonorgestrel
TABLET;ORAL-28019190-001Nov 1, 1984► Subscribe► Subscribe
Wyeth Pharms
TRIPHASIL-21
ethinyl estradiol; levonorgestrel
TABLET;ORAL-21019192-001Nov 1, 1984► Subscribe► Subscribe
Teva Branded Pharm
NORDETTE-21
ethinyl estradiol; levonorgestrel
TABLET;ORAL-21018668-001May 10, 1982► Subscribe► Subscribe
Wyeth Pharms
TRIPHASIL-21
ethinyl estradiol; levonorgestrel
TABLET;ORAL-21019192-001Nov 1, 1984► Subscribe► Subscribe
Wyeth Pharms Inc
TRIPHASIL-28
ethinyl estradiol; levonorgestrel
TABLET;ORAL-28019190-001Nov 1, 1984► Subscribe► Subscribe
Teva Branded Pharm
NORDETTE-21
ethinyl estradiol; levonorgestrel
TABLET;ORAL-21018668-001May 10, 1982► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: ethinyl estradiol; levonorgestrel

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
8,338,396Oral contraceptives to prevent pregnancy and diminish premenstrual symptomatology► Subscribe
7,772,219Methods of hormonal treatment utilizing extended cycle contraceptive regimens► Subscribe
8,680,084Oral contraceptives to prevent pregnancy and diminish premenstrual symptomatology► 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; levonorgestrel

Country Document Number Estimated Expiration
New Zealand574964► Subscribe
European Patent Office1814556► Subscribe
World Intellectual Property Organization (WIPO)9742959► Subscribe
Germany19739916► Subscribe
Denmark0911029► Subscribe
Portugal1453521► Subscribe
Israel207561► Subscribe
MexicoPA04005445► Subscribe
Russian Federation2010118424► Subscribe
Japan2005516913► 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; LEVONORGESTREL

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0001France► SubscribePRODUCT NAME: ETHINYLESTRADIOL BETADEX CLATHRATE; NAT. REGISTRATION NO/DATE: NL 32343 20060710; FIRST REGISTRATION: NL - RVG 31781 20050804
1214076/01Switzerland► SubscribePRODUCT NAME: DROSPIRENONE + ETHINYLESTRADIOL; REGISTRATION NUMBER/DATE: SWISSMEDIC 57946 13.06.2008
0160011 00192Estonia► SubscribePRODUCT NAME: LEVONORGESTREEL JA ETUENUEUELOESTRADIOOL;REG NO/DATE: EE 894715 11.11.2015
2016 00016Denmark► SubscribePRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: 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
2009 00017Denmark► SubscribePRODUCT NAME: ETHINYLESTRADIOL (SOM BETADEXCLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 42417 (DK) 20080619; FIRST REG. NO/DATE: NL 33842 20070629
00221Netherlands► SubscribePRODUCT NAME: DROSPIRENON EN ETHINYLESTRADIOL; REGISTRATION NO/DATE: RVG 23827 20000307
/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
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
0814Netherlands► SubscribePRODUCT NAME: LEVONORGESTREL EN ETHINYLESTRADIOL; NATIONAL REGISTRATION NO/DATE: RVG 117453 20151211; FIRST REGISTRATION: SK 17/0017/15-S 20150211
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Serving leading biopharmaceutical companies globally:

Covington
Queensland Health
Harvard Business School
McKinsey
US Department of Justice
Teva
Dow
Johnson and Johnson
Julphar
Novartis

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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