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Fish and Richardson
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Covington
Cipla
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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-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, Cadence Health, Duramed Pharms Barr, Barr, Bayer Hlthcare, Wyeth Pharms, Novast Labs Ltd, and Vintage Pharms Llc, and is included in sixty-six NDAs. There are nine 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-seven 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
Mayne Pharma TRIVORA-28 ethinyl estradiol; levonorgestrel TABLET;ORAL-28 074538-002 Dec 18, 1997 AB RX No Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Mayne Pharma TRIVORA-21 ethinyl estradiol; levonorgestrel TABLET;ORAL-21 074538-001 Dec 18, 1997 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Duramed Pharms Barr AVIANE-28 ethinyl estradiol; levonorgestrel TABLET;ORAL-28 075796-001 Apr 30, 2001 AB1 RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Labs Leon Farma VIENVA ethinyl estradiol; levonorgestrel TABLET;ORAL-28 201088-001 May 21, 2015 AB1 RX 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-21 ethinyl estradiol; levonorgestrel TABLET;ORAL-21 018668-001 May 10, 1982 ➤ Try a Free Trial ➤ Try a Free Trial
Teva Branded Pharm NORDETTE-28 ethinyl estradiol; levonorgestrel TABLET;ORAL-28 018782-001 Jul 21, 1982 ➤ Try a Free Trial ➤ Try a Free Trial
Wyeth Pharms Inc LYBREL ethinyl estradiol; levonorgestrel TABLET;ORAL 021864-001 May 22, 2007 ➤ 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
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Supplementary Protection Certificates for ethinyl estradiol; levonorgestrel

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00C/027 Belgium ➤ Try a Free Trial PRODUCT NAME: ETHINYLESTRADIOLUM / NORETHISTERONI ACETAS; NAT. REGISTRATION NO/DATE: 19 IS 106 F3 20000911; FIRST REGISTRATION: NL RVG 23909 19991124
49/2008 Austria ➤ Try a Free Trial PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON
156 Luxembourg ➤ Try a Free Trial PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211
C0001 France ➤ Try a Free Trial PRODUCT NAME: ETHINYLESTRADIOL BETADEX CLATHRATE; NAT. REGISTRATION NO/DATE: NL 32343 20060710; FIRST REGISTRATION: NL - RVG 31781 20050804
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Chubb
Moodys
Accenture
Baxter
McKinsey
Fish and Richardson
US Army
UBS
Cerilliant

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