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Last Updated: January 28, 2020

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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 freedom to operate?

Ethinyl estradiol; norethindrone acetate is the generic ingredient in fifty-two branded drugs marketed by Apil, Lupin Atlantis, Amneal Pharms, Glenmark Pharms Ltd, Mylan Labs Ltd, Xiromed, Aurobindo Pharma Ltd, Lupin Ltd, Vintage Pharms, Novast Labs, Barr Labs Inc, Glenmark Generics, Apotex, Vintage Pharms Llc, Glenmark Pharms, Barr, Mayne Pharma, and Parke Davis, 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. Eighteen suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for ETHINYL ESTRADIOL; NORETHINDRONE ACETATE
Recent Clinical Trials for ETHINYL ESTRADIOL; NORETHINDRONE ACETATE

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SponsorPhase
University of VirginiaN/A
Ironwood Pharmaceuticals, Inc.Phase 1
Milton S. Hershey Medical CenterPhase 3

See all ETHINYL ESTRADIOL; NORETHINDRONE ACETATE clinical trials

Recent Litigation for ETHINYL ESTRADIOL; NORETHINDRONE ACETATE

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District Court Litigation
Case NameDate
Teva Women's Health, Inc. v. Famy Care Ltd.2014-12-05
Warner Chilcott Company, LLC v. Amneal Pharmaceuticals, LLC2014-01-30
Warner Chilcott Company, LLC v. Lupin Ltd.2014-01-27

See all ETHINYL ESTRADIOL; NORETHINDRONE ACETATE litigation

PTAB Litigation
PetitionerDate
Mylan Pharmaceuticals Inc.2015-02-03

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Generic filers with tentative approvals for ETHINYL ESTRADIOL; NORETHINDRONE ACETATE
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial0.01MG,0.01MG;1MG,N/ATABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for ETHINYL ESTRADIOL; NORETHINDRONE ACETATE
Paragraph IV (Patent) Challenges for ETHINYL ESTRADIOL; NORETHINDRONE ACETATE

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 203435-001 Jun 3, 2016 AB RX No No   Start Trial   Start Trial   Start Trial
Parke Davis NORLESTRIN 28 1/50 ethinyl estradiol; norethindrone acetate TABLET;ORAL-28 016723-001 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Apil MINASTRIN 24 FE ethinyl estradiol; norethindrone acetate TABLET, CHEWABLE;ORAL 203667-001 May 8, 2013 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Glenmark Pharms Ltd NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL ethinyl estradiol; norethindrone acetate TABLET;ORAL-21 206969-001 Jan 20, 2016 AB RX No No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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   Start Trial   Start Trial
Apil TAYTULLA ethinyl estradiol; norethindrone acetate CAPSULE;ORAL 204426-001 Apr 19, 2013   Start Trial   Start Trial
Apil FEMHRT ethinyl estradiol; norethindrone acetate TABLET;ORAL 021065-002 Oct 15, 1999   Start Trial   Start Trial
Apil LO LOESTRIN FE ethinyl estradiol; norethindrone acetate TABLET;ORAL 022501-001 Oct 21, 2010   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for ETHINYL ESTRADIOL; NORETHINDRONE ACETATE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1453521 122015000093 Germany   Start Trial PRODUCT NAME: LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 87675.00.00 20150720; FIRST REGISTRATION: SLOWAKEI 17/0017/15-S 20150129
1214076 C01214076/01 Switzerland   Start Trial PRODUCT NAME: DROSPIRENONE + ETHINYLESTRADIOL; REGISTRATION NUMBER/DATE: SWISSMEDIC 57946 13.06.2008
1380301 2009C/007 Belgium   Start Trial PRODUCT NAME: DROSPIRENONE-ETHINYLESTRADIOL; AUTHORISATION NUMBER AND DATE: BE321386 20080811
0771217 CA 2006 00038 Denmark   Start Trial PRODUCT NAME: ETHINYLESTRADIOL (SOM BETA-CYCLODEXTRIN-CLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 38687 20060627; FIRST REG. NO/DATE: EU RVG 31781 20050804
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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Express Scripts

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