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Generated: January 19, 2018

DrugPatentWatch Database Preview

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 Glenmark Generics, Lupin Ltd, Sandoz, Amneal Pharms, Glenmark Pharms Ltd, Mayne Pharma, Mylan Labs Ltd, Watson Labs, Aurobindo Pharma Ltd, Teva Branded Pharm, Wyeth Pharms Inc, Novast Labs Ltd, Wyeth Pharms, Duramed Pharms Barr, Barr, Bayer Hlthcare, Labs Leon Farma, Vintage Pharms Llc, 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 thirteen patent family members in twenty-eight 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 ethinyl estradiol; levonorgestrel
International Patents:113
US Patents:10
Tradenames:45
Applicants:19
NDAs:61
Drug Master File Entries: 26
Suppliers / Packagers: 26
Clinical Trials: 824
Drug Prices:see low prices
DailyMed Link:ethinyl estradiol; levonorgestrel at DailyMed
Pharmacology for ethinyl estradiol; levonorgestrel
Tentative approvals for ETHINYL ESTRADIOL; LEVONORGESTREL
Applicant Application No. Strength Dosage Form
➤ Subscribe➤ Subscribe0.03MG,0.01MG; 0.15MG,N/ATABLET;ORAL

US Patents and Regulatory Information for ethinyl estradiol; levonorgestrel

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Amneal Pharms LEVONORGESTREL AND ETHINYL ESTRADIOL ethinyl estradiol; levonorgestrel TABLET;ORAL-28 201108-001 Feb 5, 2014 AB1 RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Wyeth Pharms Inc LYBREL ethinyl estradiol; levonorgestrel TABLET;ORAL 021864-001 May 22, 2007 DISCN Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Wyeth Pharms ALESSE ethinyl estradiol; levonorgestrel TABLET;ORAL-21 020683-001 Mar 27, 1997 DISCN Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Watson Labs QUASENSE ethinyl estradiol; levonorgestrel TABLET;ORAL 077101-001 Sep 6, 2006 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Teva Branded Pharm NORDETTE-21 ethinyl estradiol; levonorgestrel TABLET;ORAL-21 018668-001 May 10, 1982 DISCN No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Watson Labs LEVONORGESTREL AND ETHINYL ESTRADIOL ethinyl estradiol; levonorgestrel TABLET;ORAL 079218-001 Jun 6, 2011 AB RX No Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Sandoz INTROVALE ethinyl estradiol; levonorgestrel TABLET;ORAL 079064-001 Sep 27, 2010 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Vintage Pharms Llc ORSYTHIA ethinyl estradiol; levonorgestrel TABLET;ORAL-28 077099-001 May 11, 2011 AB1 RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Wyeth Pharms ALESSE ethinyl estradiol; levonorgestrel TABLET;ORAL-28 020683-002 Mar 27, 1997 DISCN Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Lupin Ltd DAYSEE ethinyl estradiol; levonorgestrel TABLET;ORAL 091467-001 Apr 10, 2013 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
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; levonorgestrel

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Teva Branded Pharm NORDETTE-21 ethinyl estradiol; levonorgestrel TABLET;ORAL-21 018668-001 May 10, 1982 ➤ Subscribe ➤ Subscribe
Wyeth Pharms TRIPHASIL-21 ethinyl estradiol; levonorgestrel TABLET;ORAL-21 019192-001 Nov 1, 1984 ➤ Subscribe ➤ Subscribe
Teva Branded Pharm SEASONALE ethinyl estradiol; levonorgestrel TABLET;ORAL 021544-001 Sep 5, 2003 ➤ Subscribe ➤ Subscribe
Wyeth Pharms TRIPHASIL-21 ethinyl estradiol; levonorgestrel TABLET;ORAL-21 019192-001 Nov 1, 1984 ➤ Subscribe ➤ Subscribe
Wyeth Pharms Inc TRIPHASIL-28 ethinyl estradiol; levonorgestrel TABLET;ORAL-28 019190-001 Nov 1, 1984 ➤ Subscribe ➤ Subscribe
Teva Branded Pharm NORDETTE-28 ethinyl estradiol; levonorgestrel TABLET;ORAL-28 018782-001 Jul 21, 1982 ➤ Subscribe ➤ Subscribe
Teva Branded Pharm NORDETTE-28 ethinyl estradiol; levonorgestrel TABLET;ORAL-28 018782-001 Jul 21, 1982 ➤ Subscribe ➤ Subscribe
Teva Branded Pharm NORDETTE-28 ethinyl estradiol; levonorgestrel TABLET;ORAL-28 018782-001 Jul 21, 1982 ➤ Subscribe ➤ Subscribe
Wyeth Pharms Inc TRIPHASIL-28 ethinyl estradiol; levonorgestrel TABLET;ORAL-28 019190-001 Nov 1, 1984 ➤ Subscribe ➤ Subscribe
Teva Branded Pharm SEASONALE ethinyl estradiol; levonorgestrel TABLET;ORAL 021544-001 Sep 5, 2003 ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for 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
8,338,396 Oral contraceptives to prevent pregnancy and diminish premenstrual symptomatology ➤ Subscribe
8,680,084 Oral contraceptives to prevent pregnancy and diminish premenstrual symptomatology ➤ Subscribe
7,772,219 Methods of hormonal treatment utilizing extended cycle contraceptive regimens ➤ Subscribe
Patent No. Title Estimated Patent Expiration

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International Patents for ethinyl estradiol; levonorgestrel

Supplementary Protection Certificates for ethinyl estradiol; levonorgestrel

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
49/2008 Austria ➤ Subscribe PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON
2009 00017 Denmark ➤ Subscribe PRODUCT NAME: ETHINYLESTRADIOL (SOM BETADEXCLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 42417 (DK) 20080619; FIRST REG. NO/DATE: NL 33842 20070629
00221 Netherlands ➤ Subscribe PRODUCT NAME: DROSPIRENON EN ETHINYLESTRADIOL; REGISTRATION NO/DATE: RVG 23827 20000307
2006 00038 Denmark ➤ Subscribe PRODUCT NAME: ETHINYLESTRADIOL (SOM BETA-CYCLODEXTRIN-CLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 38687 20060627; FIRST REG. NO/DATE: EU RVG 31781 20050804
2015000093 Germany ➤ Subscribe PRODUCT NAME: LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 87675.00.00 20150720; FIRST REGISTRATION: SLOWAKEI 17/0017/15-S 20150129
2016 00016 Denmark ➤ Subscribe PRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: SK 17/0017/15-S 20150211
/2015 Austria ➤ Subscribe PRODUCT NAME: ETHINYLESTRADIOL UND EINE KOMBINATION VON LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 136021 20150224; FIRST REGISTRATION: SK 17/0017/15-S 20150211
0814 Netherlands ➤ Subscribe PRODUCT NAME: LEVONORGESTREL EN ETHINYLESTRADIOL; NATIONAL REGISTRATION NO/DATE: RVG 117453 20151211; FIRST REGISTRATION: SK 17/0017/15-S 20150211
0160011 00192 Estonia ➤ Subscribe PRODUCT NAME: LEVONORGESTREEL JA ETUENUEUELOESTRADIOOL;REG NO/DATE: EE 894715 11.11.2015
00C/027 Belgium ➤ Subscribe PRODUCT NAME: ETHINYLESTRADIOLUM / NORETHISTERONI ACETAS; NAT. REGISTRATION NO/DATE: 19 IS 106 F3 20000911; FIRST REGISTRATION: NL RVG 23909 19991124
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving leading biopharmaceutical companies globally:

US Army
Chubb
Colorcon
Baxter
UBS
Healthtrust
Boehringer Ingelheim
Novartis
AstraZeneca

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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