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Serving hundreds of leading biopharmaceutical companies globally:

Accenture
Medtronic
Deloitte
Fuji
Federal Trade Commission
QuintilesIMS
Chubb
Colorcon
Cerilliant

Generated: July 16, 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-eight branded drugs marketed by Glenmark Generics, Avion Pharms, Lupin Ltd, Aurobindo Pharma Ltd, Labs Leon Farma, Amneal Pharms, Glenmark Pharms Ltd, Mylan Labs Ltd, Watson Labs, Mayne Pharma, 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-six 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
Pharmacology for ethinyl estradiol; levonorgestrel
Tentative approvals for ETHINYL ESTRADIOL; LEVONORGESTREL
Applicant Application No. Strength Dosage Form
➤ Try a Free Trial➤ Try a Free Trial0.03MG,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
Aurobindo Pharma Ltd ICLEVIA ethinyl estradiol; levonorgestrel TABLET;ORAL 206850-001 Jun 29, 2018 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Teva Branded Pharm LOSEASONIQUE ethinyl estradiol; levonorgestrel TABLET;ORAL 022262-001 Oct 24, 2008 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Lupin Ltd LEVONORGESTREL AND ETHINYL ESTRADIOL ethinyl estradiol; levonorgestrel TABLET;ORAL-28 200248-001 Nov 19, 2015 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Barr LEVONORGESTREL AND ETHINYL ESTRADIOL ethinyl estradiol; levonorgestrel TABLET;ORAL-28 075862-002 Apr 29, 2003 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
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-28 ethinyl estradiol; levonorgestrel TABLET;ORAL-28 018782-001 Jul 21, 1982 ➤ Try a Free Trial ➤ Try a Free Trial
Teva Branded Pharm NORDETTE-21 ethinyl estradiol; levonorgestrel TABLET;ORAL-21 018668-001 May 10, 1982 ➤ Try a Free Trial ➤ Try a Free Trial
Wyeth Pharms TRIPHASIL-21 ethinyl estradiol; levonorgestrel TABLET;ORAL-21 019192-001 Nov 1, 1984 ➤ Try a Free Trial ➤ Try a Free Trial
Teva Branded Pharm SEASONALE ethinyl estradiol; levonorgestrel TABLET;ORAL 021544-001 Sep 5, 2003 ➤ Try a Free Trial ➤ Try a Free Trial
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 ➤ Try a Free Trial
8,680,084 Oral contraceptives to prevent pregnancy and diminish premenstrual symptomatology ➤ Try a Free Trial
7,772,219 Methods of hormonal treatment utilizing extended cycle contraceptive regimens ➤ Try a Free Trial
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
2015000093 Germany ➤ Try a Free Trial PRODUCT NAME: LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 87675.00.00 20150720; FIRST REGISTRATION: SLOWAKEI 17/0017/15-S 20150129
0160011 00192 Estonia ➤ Try a Free Trial PRODUCT NAME: LEVONORGESTREEL JA ETUENUEUELOESTRADIOOL;REG NO/DATE: EE 894715 11.11.2015
2016 00016 Denmark ➤ Try a Free Trial PRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: SK 17/0017/15-S 20150211
0814 Netherlands ➤ Try a Free Trial PRODUCT NAME: LEVONORGESTREL EN ETHINYLESTRADIOL; NATIONAL REGISTRATION NO/DATE: RVG 117453 20151211; FIRST REGISTRATION: 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:

US Army
QuintilesIMS
Cipla
Fish and Richardson
Fuji
Cerilliant
Accenture
Baxter
Healthtrust

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