You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: March 19, 2024

Ethinyl estradiol; norethindrone - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard


What are the generic drug sources for ethinyl estradiol; norethindrone and what is the scope of freedom to operate?

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
Watson Labs Teva NORETHINDRONE AND ETHINYL ESTRADIOL (10/11) ethinyl estradiol; norethindrone TABLET;ORAL-28 071044-001 Apr 1, 1988 RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Teva Pharms Usa Inc FINZALA ethinyl estradiol; norethindrone acetate TABLET;ORAL 210087-001 Apr 7, 2020 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
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
Glenmark Pharms Ltd HAILEY 24 FE ethinyl estradiol; norethindrone acetate TABLET;ORAL 204847-001 Nov 17, 2017 AB RX No Yes ⤷  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

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.