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Accenture
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Dow
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Chinese Patent Office
Chubb
Argus Health
Express Scripts
Farmers Insurance

Generated: August 19, 2018

DrugPatentWatch Database Preview

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 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 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.

Ethinyl estradiol; norethindrone acetate has forty patent family members in twenty-four countries.

There are twenty-six drug master file entries for ethinyl estradiol; norethindrone acetate. Twenty-one suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for ETHINYL ESTRADIOL; NORETHINDRONE ACETATE
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
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
Mayne Pharma NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL ethinyl estradiol; norethindrone acetate TABLET;ORAL-28 076629-001 Mar 18, 2010 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Barr TRI-LEGEST FE ethinyl estradiol; norethindrone acetate TABLET;ORAL-28 076105-001 Oct 26, 2007 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Lupin Ltd BLISOVI FE 1/20 ethinyl estradiol; norethindrone acetate TABLET;ORAL-28 201584-001 Nov 18, 2015 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Apil LOESTRIN 21 1/20 ethinyl estradiol; norethindrone acetate TABLET;ORAL-21 017876-001 Approved Prior to Jan 1, 1982 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Vintage Pharms Llc GILDESS FE 1.5/30 ethinyl estradiol; norethindrone acetate TABLET;ORAL-28 077075-001 Apr 28, 2005 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
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
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

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International Patents for ETHINYL ESTRADIOL; NORETHINDRONE ACETATE

Country Document Number Estimated Expiration
European Patent Office 2305266 ➤ Try a Free Trial
Australia 763971 ➤ Try a Free Trial
Mexico PA01009817 ➤ Try a Free Trial
United Kingdom 9907715 ➤ Try a Free Trial
Poland 196823 ➤ Try a Free Trial
Japan 4636692 ➤ Try a Free Trial
Norway 20014719 ➤ 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
/2015 Austria ➤ Try a Free Trial PRODUCT NAME: ETHINYLESTRADIOL UND EINE KOMBINATION VON LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 136021 20150224; FIRST REGISTRATION: SK 17/0017/15-S 20150211
2016 00016 Denmark ➤ Try a Free Trial PRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: SK 17/0017/15-S 20150211
00221 Netherlands ➤ Try a Free Trial PRODUCT NAME: DROSPIRENON EN ETHINYLESTRADIOL; REGISTRATION NO/DATE: RVG 23827 20000307
49/2008 Austria ➤ Try a Free Trial PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON
1214076/01 Switzerland ➤ Try a Free Trial PRODUCT NAME: DROSPIRENONE + ETHINYLESTRADIOL; REGISTRATION NUMBER/DATE: SWISSMEDIC 57946 13.06.2008
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
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Express Scripts
Fuji
Cipla
Moodys
Boehringer Ingelheim
Mallinckrodt
Farmers Insurance
Merck
Baxter

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