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Generated: February 15, 2019

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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.

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-two 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
➤ 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
Apil LOESTRIN FE 1/20 ethinyl estradiol; norethindrone acetate TABLET;ORAL-28 017354-001 Approved Prior to Jan 1, 1982 AB RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Aurobindo Pharma Ltd AUROVELA 1/20 ethinyl estradiol; norethindrone acetate TABLET;ORAL-21 207506-001 Jun 16, 2017 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Mylan Labs Ltd NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ethinyl estradiol; norethindrone acetate TABLET;ORAL 205049-001 May 31, 2016 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Apil ESTROSTEP FE ethinyl estradiol; norethindrone acetate TABLET;ORAL-28 020130-002 Oct 9, 1996 AB RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Novast Labs LERIBANE ethinyl estradiol; norethindrone acetate TABLET;ORAL 203435-001 Jun 3, 2016 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Glenmark Generics NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL ethinyl estradiol; norethindrone acetate TABLET;ORAL 203038-002 Apr 2, 2015 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Parke Davis NORLESTRIN 21 2.5/50 ethinyl estradiol; norethindrone acetate TABLET;ORAL-21 016852-001 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 MINASTRIN 24 FE ethinyl estradiol; norethindrone acetate TABLET, CHEWABLE;ORAL 203667-001 May 8, 2013 ➤ Sign Up ➤ Sign Up
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 ESTROSTEP 21 ethinyl estradiol; norethindrone acetate TABLET;ORAL-21 020130-001 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 ESTROSTEP 21 ethinyl estradiol; norethindrone acetate TABLET;ORAL-21 020130-001 Oct 9, 1996 ➤ Sign Up ➤ Sign Up
Apil FEMHRT ethinyl estradiol; norethindrone acetate TABLET;ORAL 021065-002 Oct 15, 1999 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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International Patents for ethinyl estradiol; norethindrone acetate

Supplementary Protection Certificates for ethinyl estradiol; norethindrone acetate

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
/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
0814 Netherlands ➤ Sign Up PRODUCT NAME: LEVONORGESTREL EN ETHINYLESTRADIOL; NATIONAL REGISTRATION NO/DATE: RVG 117453 20151211; FIRST REGISTRATION: SK 17/0017/15-S 20150211
156 Luxembourg ➤ Sign Up PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211
1214076/01 Switzerland ➤ Sign Up PRODUCT NAME: DROSPIRENONE + ETHINYLESTRADIOL; REGISTRATION NUMBER/DATE: SWISSMEDIC 57946 13.06.2008
00C/027 Belgium ➤ Sign Up PRODUCT NAME: ETHINYLESTRADIOLUM / NORETHISTERONI ACETAS; NAT. REGISTRATION NO/DATE: 19 IS 106 F3 20000911; FIRST REGISTRATION: NL RVG 23909 19991124
C0001 France ➤ Sign Up PRODUCT NAME: ETHINYLESTRADIOL BETADEX CLATHRATE; NAT. REGISTRATION NO/DATE: NL 32343 20060710; FIRST REGISTRATION: NL - RVG 31781 20050804
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:

Boehringer Ingelheim
US Department of Justice
Argus Health
Covington
Cantor Fitzgerald
AstraZeneca
Farmers Insurance
Chinese Patent Office
Johnson and Johnson

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