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Deloitte
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Generated: November 18, 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, 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
Novast Labs LERIBANE ethinyl estradiol; norethindrone acetate TABLET;ORAL 203435-002 Jun 3, 2016 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
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
Barr Labs Inc NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL ethinyl estradiol; norethindrone acetate TABLET;ORAL 076221-001 Nov 6, 2009 AB RX No Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Novast Labs LARIN 24 FE ethinyl estradiol; norethindrone acetate TABLET;ORAL 202994-001 Feb 18, 2015 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Novast Labs LARIN 1/20 ethinyl estradiol; norethindrone acetate TABLET;ORAL-21 202995-001 Dec 4, 2013 AB RX 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 LO LOESTRIN FE ethinyl estradiol; norethindrone acetate TABLET;ORAL 022501-001 Oct 21, 2010 ➤ Sign Up ➤ Sign Up
Apil TAYTULLA ethinyl estradiol; norethindrone acetate CAPSULE;ORAL 204426-001 Apr 19, 2013 ➤ 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
Apil ESTROSTEP FE ethinyl estradiol; norethindrone acetate TABLET;ORAL-28 020130-002 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
00221 Netherlands ➤ Sign Up PRODUCT NAME: DROSPIRENON EN ETHINYLESTRADIOL; REGISTRATION NO/DATE: RVG 23827 20000307
2006 00038 Denmark ➤ Sign Up PRODUCT NAME: ETHINYLESTRADIOL (SOM BETA-CYCLODEXTRIN-CLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 38687 20060627; FIRST REG. NO/DATE: EU RVG 31781 20050804
1214076/01 Switzerland ➤ Sign Up PRODUCT NAME: DROSPIRENONE + ETHINYLESTRADIOL; REGISTRATION NUMBER/DATE: SWISSMEDIC 57946 13.06.2008
C0001 France ➤ Sign Up PRODUCT NAME: ETHINYLESTRADIOL BETADEX CLATHRATE; NAT. REGISTRATION NO/DATE: NL 32343 20060710; FIRST REGISTRATION: NL - RVG 31781 20050804
156 Luxembourg ➤ Sign Up PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211
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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