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Medtronic
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Federal Trade Commission
Cantor Fitzgerald
Mallinckrodt
UBS
Moodys
Colorcon
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Generated: November 17, 2018

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Ethinyl estradiol; levonorgestrel - Generic Drug Details

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What are the generic 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, Wyeth Pharms, Duramed Pharms Barr, Barr, Bayer Hlthcare, 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.

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.

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
Amneal Pharms LEVONORGESTREL AND ETHINYL ESTRADIOL ethinyl estradiol; levonorgestrel TABLET;ORAL 203872-001 Dec 22, 2015 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Barr PORTIA-21 ethinyl estradiol; levonorgestrel TABLET;ORAL-21 075866-001 May 23, 2002 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Wyeth Pharms ALESSE ethinyl estradiol; levonorgestrel TABLET;ORAL-28 020683-002 Mar 27, 1997 DISCN Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Watson Labs LEVORA 0.15/30-21 ethinyl estradiol; levonorgestrel TABLET;ORAL-21 073592-001 Dec 13, 1993 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
Wyeth Pharms TRIPHASIL-21 ethinyl estradiol; levonorgestrel TABLET;ORAL-21 019192-001 Nov 1, 1984 ➤ 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
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 Inc TRIPHASIL-28 ethinyl estradiol; levonorgestrel TABLET;ORAL-28 019190-001 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
156 Luxembourg ➤ Try a Free Trial PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211
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
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
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:

Medtronic
Julphar
Federal Trade Commission
Cantor Fitzgerald
Mallinckrodt
UBS
Moodys
Colorcon
Deloitte

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