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Last Updated: December 7, 2021

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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 patent protection?

Ethinyl estradiol; norethindrone acetate is the generic ingredient in fifty-six branded drugs marketed by Xiromed, Slayback Pharma Llc, Amneal Pharms, Apil, Teva Pharms Usa Inc, Lupin, Glenmark Pharms Ltd, Mylan Labs Ltd, 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 seventy 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.

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

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 it Free⤷  Try it Free0.01MG,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
Parke Davis NORLESTRIN 28 1/50 ethinyl estradiol; norethindrone acetate TABLET;ORAL-28 016723-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Mylan Labs Ltd NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL ethinyl estradiol; norethindrone acetate TABLET;ORAL-21 202771-001 Nov 6, 2013 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Mylan Labs Ltd NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL ethinyl estradiol; norethindrone acetate TABLET;ORAL-21 202770-001 Feb 19, 2015 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Glenmark Pharms Ltd NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL ethinyl estradiol; norethindrone acetate TABLET;ORAL-21 206969-001 Jan 20, 2016 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
>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 21 ethinyl estradiol; norethindrone acetate TABLET;ORAL-21 020130-001 Oct 9, 1996 ⤷  Try it Free ⤷  Try it Free
Apil TAYTULLA ethinyl estradiol; norethindrone acetate CAPSULE;ORAL 204426-001 Apr 19, 2013 ⤷  Try it Free ⤷  Try it Free
Apil MINASTRIN 24 FE ethinyl estradiol; norethindrone acetate TABLET, CHEWABLE;ORAL 203667-001 May 8, 2013 ⤷  Try it Free ⤷  Try it Free
Teva Branded Pharm LOESTRIN 24 FE ethinyl estradiol; norethindrone acetate TABLET;ORAL 021871-001 Feb 17, 2006 ⤷  Try it Free ⤷  Try it Free
>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
1214076 SZ 49/2008 Austria ⤷  Try it Free PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON
1453521 93156 Luxembourg ⤷  Try it Free PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211
1453521 300814 Netherlands ⤷  Try it Free PRODUCT NAME: LEVONORGESTREL EN ETHINYLESTRADIOL; NATIONAL REGISTRATION NO/DATE: RVG 117453 20151211; FIRST REGISTRATION: SK 17/0017/15-S 20150211
0771217 07C0001 France ⤷  Try it Free PRODUCT NAME: ETHINYLESTRADIOL BETADEX CLATHRATE; NAT. REGISTRATION NO/DATE: NL 32343 20060710; FIRST REGISTRATION: NL - RVG 31781 20050804
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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