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Last Updated: November 29, 2020

DrugPatentWatch Database Preview

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 patent protection?

Ethinyl estradiol; norethindrone acetate is the generic ingredient in fifty-four branded drugs marketed by Apil, Teva Pharms Usa Inc, Lupin, Amneal Pharms, Glenmark Pharms Ltd, Mylan Labs Ltd, Xiromed, Aurobindo Pharma Ltd, Lupin Ltd, Vintage Pharms, Novast Labs, Teva Branded Pharm, Barr Labs Inc, Glenmark Generics, Apotex, Vintage Pharms Llc, Glenmark Pharms, Barr, Mayne Pharma, and Parke Davis, and is included in sixty-seven NDAs. There are two 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

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
University of VirginiaN/A
Ironwood Pharmaceuticals, Inc.Phase 1
National Institutes of Health (NIH)Phase 3

See all ethinyl estradiol; norethindrone acetate clinical trials

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
Lupin Ltd FYAVOLV ethinyl estradiol; norethindrone acetate TABLET;ORAL 204213-002 Dec 10, 2015 AB RX No No   Start Trial   Start Trial   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
Novast Labs CHABELINA FE ethinyl estradiol; norethindrone acetate TABLET;ORAL-28 202962-001 Apr 15, 2020 AB RX No No   Start Trial   Start Trial   Start Trial
Mylan Labs Ltd NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL ethinyl estradiol; norethindrone acetate TABLET;ORAL 207259-001 Dec 27, 2016 AB RX No No   Start Trial   Start Trial   Start Trial
Vintage Pharms GILDESS 24 FE ethinyl estradiol; norethindrone acetate TABLET;ORAL 090293-001 Dec 1, 2014 AB RX No No   Start Trial   Start Trial   Start Trial
Mylan Labs Ltd NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL ethinyl estradiol; norethindrone acetate TABLET;ORAL-28 205069-001 Jun 22, 2018 DISCN No No   Start Trial   Start Trial   Start Trial
Vintage Pharms Llc GILDESS FE 1/20 ethinyl estradiol; norethindrone acetate TABLET;ORAL-28 077077-001 May 20, 2005 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

Supplementary Protection Certificates for ethinyl estradiol; norethindrone acetate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1453521 15C0050 France   Start Trial PRODUCT NAME: ETHINYLESTRADIOL ET MELANGE DE LEVONORGESTREL ET ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: NL 42237 20150320; FIRST REGISTRATION: SK - 17/0017/15-S 20150129
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
0398460 C300221 Netherlands   Start Trial PRODUCT NAME: DROSPIRENON EN ETHINYLESTRADIOL; REGISTRATION NO/DATE: RVG 23827 20000307
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
1214076 49/2008 Austria   Start Trial PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON; REGISTRATION NO/DATE: 1-27586 20080612
1453521 39/2015 Austria   Start 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Express Scripts
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