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Generated: September 21, 2018

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Ethinyl estradiol; norethindrone acetate - Generic Drug Details

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What are the generic sources for ethinyl estradiol; norethindrone acetate and what is the scope of ethinyl estradiol; norethindrone acetate patent protection?

Ethinyl estradiol; norethindrone acetate is the generic ingredient in fifty-two branded drugs marketed by Apil, Lupin Atlantis, Amneal Pharms, Chemo Research Sl, Glenmark Pharms Ltd, Mylan Labs Ltd, Aurobindo Pharma Ltd, Lupin Ltd, Vintage Pharms, Novast Labs Ltd, Barr Labs Inc, Glenmark Generics, Apotex Inc, Vintage Pharms Llc, Barr, Mayne Pharma, Parke Davis, and Glenmark Pharms, and is included in sixty-five NDAs. There are three patents protecting this compound and two 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; norethindrone acetate. Twenty-two suppliers are listed for this compound. There are two tentative approvals for this compound.

Pharmacology for ethinyl estradiol; norethindrone acetate
Tentative approvals for ETHINYL ESTRADIOL; NORETHINDRONE ACETATE
Applicant Application No. Strength Dosage Form
➤ Sign Up➤ Sign Up0.02MG;1MGTABLET, CHEWABLE;ORAL
➤ Sign Up➤ Sign Up0.01MG,0.01MG;1MG,N/ATABLET;ORAL

US Patents and Regulatory Information for ethinyl estradiol; norethindrone acetate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mylan Labs Ltd NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL ethinyl estradiol; norethindrone acetate TABLET;ORAL-28 202772-001 Nov 14, 2013 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Mayne Pharma NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL ethinyl estradiol; norethindrone acetate TABLET;ORAL-28 076629-001 Mar 18, 2010 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Vintage Pharms GILDESS 24 FE ethinyl estradiol; norethindrone acetate TABLET;ORAL 090293-001 Dec 1, 2014 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Barr JUNEL 1/20 ethinyl estradiol; norethindrone acetate TABLET;ORAL-21 076380-001 May 30, 2003 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Novast Labs Ltd LARIN FE 1/20 ethinyl estradiol; norethindrone acetate TABLET;ORAL-28 091454-001 Aug 26, 2013 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Parke Davis NORLESTRIN 21 1/50 ethinyl estradiol; norethindrone acetate TABLET;ORAL-21 016749-001 Approved Prior to Jan 1, 1982 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; norethindrone acetate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Apil ESTROSTEP FE ethinyl estradiol; norethindrone acetate TABLET;ORAL-28 020130-002 Oct 9, 1996 ➤ Sign Up ➤ Sign Up
Apil ESTROSTEP FE ethinyl estradiol; norethindrone acetate TABLET;ORAL-28 020130-002 Oct 9, 1996 ➤ Sign Up ➤ Sign Up
Apil TAYTULLA ethinyl estradiol; norethindrone acetate CAPSULE;ORAL 204426-001 Apr 19, 2013 ➤ Sign Up ➤ Sign Up
Apil FEMHRT ethinyl estradiol; norethindrone acetate TABLET;ORAL 021065-001 Jan 14, 2005 ➤ Sign Up ➤ Sign Up
Apil MINASTRIN 24 FE ethinyl estradiol; norethindrone acetate TABLET, CHEWABLE;ORAL 203667-001 May 8, 2013 ➤ Sign Up ➤ Sign Up
Apil ESTROSTEP 21 ethinyl estradiol; norethindrone acetate TABLET;ORAL-21 020130-001 Oct 9, 1996 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Supplementary Protection Certificates for ethinyl estradiol; norethindrone acetate

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2009 00017 Denmark ➤ Sign Up PRODUCT NAME: ETHINYLESTRADIOL (SOM BETADEXCLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 42417 (DK) 20080619; FIRST REG. NO/DATE: NL 33842 20070629
/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
156 Luxembourg ➤ Sign Up PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211
0814 Netherlands ➤ Sign Up PRODUCT NAME: LEVONORGESTREL EN ETHINYLESTRADIOL; NATIONAL REGISTRATION NO/DATE: RVG 117453 20151211; FIRST REGISTRATION: SK 17/0017/15-S 20150211
00221 Netherlands ➤ Sign Up PRODUCT NAME: DROSPIRENON EN ETHINYLESTRADIOL; REGISTRATION NO/DATE: RVG 23827 20000307
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
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Deloitte
Mallinckrodt
Argus Health
Harvard Business School
Express Scripts
US Department of Justice
Fuji
McKesson
Daiichi Sankyo

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