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Last Updated: March 29, 2024

Ethinyl estradiol; norethindrone - Generic Drug Details


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What are the generic drug sources for ethinyl estradiol; norethindrone and what is the scope of patent protection?

Ethinyl estradiol; norethindrone is the generic ingredient in one hundred and seventeen branded drugs marketed by Lupin Ltd, Apil, Mylan Labs Ltd, Aurobindo Pharma, Amneal Pharms, Barr, Naari Pte Ltd, Allergan, Ortho Mcneil Pharm, LPI, Watson Pharms Teva, Watson Labs, Watson Labs Teva, Ortho Mcneil Janssen, Janssen Pharms, Warner Chilcott, Dr Reddys Labs Sa, Glenmark Generics, Vintage Pharms, Vintage Pharms Llc, Novast Labs Ltd, Warner Chilcott Llc, Xiromed, Slayback Pharma Llc, Glenmark Pharms Ltd, Teva Pharms Usa Inc, Novast Labs, Teva Branded Pharm, Lupin, Barr Labs Inc, Apotex, Glenmark Pharms, Parke Davis, and Mylan, and is included in one hundred and forty-nine NDAs. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Fourteen suppliers are listed for this compound. There is one tentative approval for this compound.

Recent Clinical Trials for ethinyl estradiol; norethindrone

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

SponsorPhase
University of VirginiaEarly Phase 1
CelerionPhase 1
Achillion, a wholly owned subsidiary of AlexionPhase 1

See all ethinyl estradiol; norethindrone clinical trials

Generic filers with tentative approvals for ETHINYL ESTRADIOL; NORETHINDRONE
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
Drug ClassEstrogen
Progestin
Mechanism of ActionEstrogen Receptor Agonists

US Patents and Regulatory Information for ethinyl estradiol; norethindrone

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ortho Mcneil Pharm MODICON 21 ethinyl estradiol; norethindrone TABLET;ORAL-21 017488-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Dr Reddys Labs Sa TRI-NORINYL 21-DAY ethinyl estradiol; norethindrone TABLET;ORAL-21 018977-001 Apr 13, 1984 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Watson Labs NORETHINDRONE AND ETHINYL ESTRADIOL ethinyl estradiol; norethindrone TABLET;ORAL-21 070684-001 Jan 29, 1987 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Vintage Pharms Llc GILDESS FE 1/20 ethinyl estradiol; norethindrone acetate TABLET;ORAL-28 077077-001 May 20, 2005 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Dr Reddys Labs Sa NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ethinyl estradiol; norethindrone acetate CAPSULE;ORAL 213901-001 Apr 28, 2022 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Barr JUNEL 1.5/30 ethinyl estradiol; norethindrone acetate TABLET;ORAL-21 076381-001 May 30, 2003 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Apil LO LOESTRIN FE ethinyl estradiol; norethindrone acetate TABLET;ORAL 022501-001 Oct 21, 2010 RX Yes Yes ⤷  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

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