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Serving hundreds of leading biopharmaceutical companies globally:

Boehringer Ingelheim
Teva
Fish and Richardson
QuintilesIMS
Baxter
McKinsey
AstraZeneca
UBS
Moodys

Generated: April 20, 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-seven branded drugs marketed by Glenmark Generics, Avion Pharms, Lupin Ltd, Labs Leon Farma, 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, and Vintage Pharms Llc, and is included in sixty-five NDAs. There are eight 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 two patent family members in twenty-seven countries.

There are twenty-six drug master file entries for ethinyl estradiol; levonorgestrel. Twenty-eight suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for ethinyl estradiol; levonorgestrel
International Patents:102
US Patents:8
Tradenames:47
Applicants:18
NDAs:65
Drug Master File Entries: 26
Suppliers / Packagers: 28
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
➤ Sign Up➤ Sign Up0.03MG,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
Lupin Ltd LEVONORGESTREL AND ETHINYL ESTRADIOL ethinyl estradiol; levonorgestrel TABLET;ORAL 091674-001 Oct 26, 2011 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Bayer Hlthcare LEVLITE ethinyl estradiol; levonorgestrel TABLET;ORAL-28 020860-002 Jul 13, 1998 DISCN Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Duramed Pharms Barr AVIANE-21 ethinyl estradiol; levonorgestrel TABLET;ORAL-21 075796-002 Apr 30, 2001 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Barr LEVONORGESTREL AND ETHINYL ESTRADIOL ethinyl estradiol; levonorgestrel TABLET;ORAL-28 075862-002 Apr 29, 2003 DISCN 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; 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 ➤ Sign Up ➤ Sign Up
Teva Branded Pharm NORDETTE-21 ethinyl estradiol; levonorgestrel TABLET;ORAL-21 018668-001 May 10, 1982 ➤ Sign Up ➤ Sign Up
Teva Branded Pharm NORDETTE-21 ethinyl estradiol; levonorgestrel TABLET;ORAL-21 018668-001 May 10, 1982 ➤ Sign Up ➤ Sign Up
Teva Branded Pharm SEASONALE ethinyl estradiol; levonorgestrel TABLET;ORAL 021544-001 Sep 5, 2003 ➤ 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; 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
7,772,219 Methods of hormonal treatment utilizing extended cycle contraceptive regimens ➤ Sign Up
8,338,396 Oral contraceptives to prevent pregnancy and diminish premenstrual symptomatology ➤ Sign Up
8,680,084 Oral contraceptives to prevent pregnancy and diminish premenstrual symptomatology ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for ethinyl estradiol; levonorgestrel

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0160011 00192 Estonia ➤ Sign Up PRODUCT NAME: LEVONORGESTREEL JA ETUENUEUELOESTRADIOOL;REG NO/DATE: EE 894715 11.11.2015
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
/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
00C/027 Belgium ➤ Sign Up 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 hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
Julphar
QuintilesIMS
Chinese Patent Office
US Department of Justice
Dow
Moodys
Chubb
Colorcon

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