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Generated: November 19, 2018

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ETHINYL ESTRADIOL; NORETHINDRONE ACETATE - Generic Drug Details

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What are the generic drug sources for ethinyl estradiol; norethindrone acetate and what is the scope of ethinyl estradiol; norethindrone acetate freedom to operate?

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
➤ Try a Free Trial➤ Try a Free Trial0.02MG;1MGTABLET, CHEWABLE;ORAL
➤ Try a Free Trial➤ Try a Free Trial0.01MG,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
Barr TRI-LEGEST 21 ethinyl estradiol; norethindrone acetate TABLET;ORAL-21 076405-001 Oct 26, 2007 RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Apil LOESTRIN 24 FE ethinyl estradiol; norethindrone acetate TABLET;ORAL 021871-001 Feb 17, 2006 AB RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Mylan Labs Ltd NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL ethinyl estradiol; norethindrone acetate TABLET;ORAL-28 202741-001 Feb 20, 2015 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Novast Labs LARIN FE 1/20 ethinyl estradiol; norethindrone acetate TABLET;ORAL-28 091454-001 Aug 26, 2013 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Aurobindo Pharma Ltd AUROVELA FE 1.5/30 ethinyl estradiol; norethindrone acetate TABLET;ORAL-28 207580-001 Jun 15, 2017 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Apil FEMHRT ethinyl estradiol; norethindrone acetate TABLET;ORAL 021065-001 Jan 14, 2005 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Lupin Atlantis MIBELAS 24 FE ethinyl estradiol; norethindrone acetate TABLET, CHEWABLE;ORAL 206287-001 May 24, 2016 AB 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; NORETHINDRONE ACETATE

International Patents for ETHINYL ESTRADIOL; NORETHINDRONE ACETATE

Country Document Number Estimated Expiration
Hungary 227155 ➤ Try a Free Trial
Denmark 1173153 ➤ Try a Free Trial
Brazil 0009373 ➤ Try a Free Trial
China 104248639 ➤ Try a Free Trial
European Patent Office 1877062 ➤ Try a Free Trial
China 101189015 ➤ Try a Free Trial
Hong Kong 1040364 ➤ Try a Free Trial
Country Document Number Estimated Expiration

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Supplementary Protection Certificates for ETHINYL ESTRADIOL; NORETHINDRONE ACETATE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
49/2008 Austria ➤ Try a Free Trial PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON
2009 00017 Denmark ➤ Try a Free Trial PRODUCT NAME: ETHINYLESTRADIOL (SOM BETADEXCLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 42417 (DK) 20080619; FIRST REG. NO/DATE: NL 33842 20070629
00221 Netherlands ➤ Try a Free Trial PRODUCT NAME: DROSPIRENON EN ETHINYLESTRADIOL; REGISTRATION NO/DATE: RVG 23827 20000307
2006 00038 Denmark ➤ Try a Free Trial PRODUCT NAME: ETHINYLESTRADIOL (SOM BETA-CYCLODEXTRIN-CLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 38687 20060627; FIRST REG. NO/DATE: EU RVG 31781 20050804
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
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:

McKinsey
Cipla
AstraZeneca
Fuji
Chubb
Covington
Boehringer Ingelheim
Dow
Cantor Fitzgerald

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