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Last Updated: March 30, 2024

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-eight branded drugs marketed by Xiromed, Slayback Pharma Llc, Amneal Pharms, Dr Reddys Labs Sa, Glenmark Pharms Ltd, Apil, Aurobindo Pharma, Lupin Ltd, Teva Pharms Usa Inc, Vintage Pharms, Novast Labs, Teva Branded Pharm, Lupin, Barr Labs Inc, Glenmark Generics, Mylan Labs Ltd, Apotex, Vintage Pharms Llc, Glenmark Pharms, Barr, Parke Davis, and Mylan, and is included in seventy-three NDAs. There is one patent protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Ethinyl estradiol; norethindrone acetate has nine patent family members in seven countries.

Twenty-four 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 VirginiaEarly Phase 1
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
⤷  Try a Trial⤷  Try a 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
Drug ClassEstrogen
Progestin
Mechanism of ActionEstrogen Receptor Agonists
Paragraph IV (Patent) Challenges for ETHINYL ESTRADIOL; NORETHINDRONE ACETATE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
LO LOESTRIN FE Tablets ethinyl estradiol; norethindrone acetate 1 mg/0.01 mg, 0.01 mg and 75 mg 022501 1 2011-04-29

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
Apotex NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ethinyl estradiol; norethindrone acetate TABLET;ORAL 208639-001 Mar 21, 2018 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Lupin MIBELAS 24 FE ethinyl estradiol; norethindrone acetate TABLET;ORAL 206287-001 May 24, 2016 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Lupin Ltd FYAVOLV ethinyl estradiol; norethindrone acetate TABLET;ORAL 204213-001 Dec 10, 2015 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Apil FEMHRT ethinyl estradiol; norethindrone acetate TABLET;ORAL 021065-001 Jan 14, 2005 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Apil ESTROSTEP 21 ethinyl estradiol; norethindrone acetate TABLET;ORAL-21 020130-001 Oct 9, 1996 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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

International Patents for ethinyl estradiol; norethindrone acetate

Country Patent Number Title Estimated Expiration
World Intellectual Property Organization (WIPO) 2006115871 ⤷  Try a Trial
European Patent Office 1877062 REGIME CONTRACEPTIF DE DOSAGE D STROGENES ETENDU (EXTENDED ESTROGEN DOSING CONTRACEPTIVE REGIMEN) ⤷  Try a Trial
Israel 186656 METHOD OF CONTRACEPTION AND A CONTRACEPTION KIT ⤷  Try a Trial
China 104248639 Extended estrogen dosing contraceptive regimen ⤷  Try a Trial
Hong Kong 1205468 延長的雌激素定量給藥避孕療法 (EXTENDED ESTROGEN DOSING CONTRACEPTIVE REGIMEN) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ethinyl estradiol; norethindrone acetate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1380301 2009C/007 Belgium ⤷  Try a Trial PRODUCT NAME: DROSPIRENONE-ETHINYLESTRADIOL; AUTHORISATION NUMBER AND DATE: BE321386 20080811
1453521 300814 Netherlands ⤷  Try a Trial PRODUCT NAME: LEVONORGESTREL EN ETHINYLESTRADIOL; NATIONAL REGISTRATION NO/DATE: RVG 117453 20151211; FIRST REGISTRATION: SK 17/0017/15-S 20150211
1453521 122015000093 Germany ⤷  Try a Trial PRODUCT NAME: LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 87675.00.00 20150720; FIRST REGISTRATION: SLOWAKEI 17/0017/15-S 20150129
1453521 39/2015 Austria ⤷  Try a 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
1453521 CA 2016 00016 Denmark ⤷  Try a Trial PRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: SK 17/0017/15-S 20150211
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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