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Last Updated: March 29, 2024

Ethinyl estradiol - Generic Drug Details


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

Ethinyl estradiol is the generic ingredient in two hundred and thirty-one branded drugs marketed by Schering, Pharmacia And Upjohn, Organon Usa Inc, Gd Searle Llc, Watson Pharms Teva, Watson Labs, Mylan Labs Ltd, Barr, Novast Labs, Dr Reddys Labs Sa, Amneal, Xiromed, Teva Pharms Usa Inc, Organon Usa Organon, Pfizer, Parke Davis, Agile, Glenmark Generics, Avion Pharms, Lupin Ltd, Aurobindo Pharma Ltd, Amneal Pharms, Glenmark Pharms Ltd, Aurobindo Pharma, Teva Branded Pharm, Wyeth Pharms Inc, Sun Pharm, Exeltis Usa Inc, Cadence Health, Duramed Pharms Barr, Bayer Hlthcare, Wyeth Pharms, Novast Labs Ltd, Hetero Labs, Naari Pte Ltd, Vintage Pharms Llc, Zydus Noveltech Inc, Teva Pharms Usa, Janssen Pharms, Mylan Technologies, Apil, Allergan, Ortho Mcneil Pharm, LPI, Watson Labs Teva, Ortho Mcneil Janssen, Warner Chilcott, Vintage Pharms, Warner Chilcott Llc, Slayback Pharma Llc, Lupin, Barr Labs Inc, Apotex, Glenmark Pharms, Mylan, Lupin Pharms, and Mayne Pharma, and is included in three hundred NDAs. There are seventeen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

There are sixteen drug master file entries for ethinyl estradiol. There are three tentative approvals for this compound.

Drug Prices for ethinyl estradiol

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Recent Clinical Trials for ethinyl estradiol

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

SponsorPhase
ParexelPhase 1
Lupin Research IncPhase 2
Women's Hospital School Of Medicine Zhejiang UniversityPhase 4

See all ethinyl estradiol clinical trials

Generic filers with tentative approvals for ETHINYL ESTRADIOL
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a Trial0.03MG,0.01MG; 0.15MG,N/ATABLET;ORAL
⤷  Try a Trial⤷  Try a Trial0.02MG,0.15MG;0.025MG,0.15MG;0.03MG,0.15MG;0.01MG,N/ATABLET;ORAL
⤷  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.

Medical Subject Heading (MeSH) Categories for ethinyl estradiol

US Patents and Regulatory Information for ethinyl estradiol

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Watson Labs OGESTREL 0.5/50-28 ethinyl estradiol; norgestrel TABLET;ORAL-28 075406-002 Dec 15, 1999 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Vintage Pharms Llc GILDESS FE 1.5/30 ethinyl estradiol; norethindrone acetate TABLET;ORAL-28 077075-001 Apr 28, 2005 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Mylan Labs Ltd ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL ethinyl estradiol; ethynodiol diacetate TABLET;ORAL-28 204704-001 Feb 9, 2016 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Avion Pharms BALCOLTRA ethinyl estradiol; levonorgestrel TABLET;ORAL 208612-001 Jan 9, 2018 AB3 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Mylan Labs Ltd NORETHINDRONE AND ETHINYL ESTRADIOL ethinyl estradiol; norethindrone TABLET;ORAL-28 200488-001 Oct 21, 2015 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Novast Labs Ltd ELINEST ethinyl estradiol; norgestrel TABLET;ORAL-28 091105-001 Mar 28, 2012 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Novast Labs Ltd WERA ethinyl estradiol; norethindrone TABLET;ORAL-28 091204-001 Mar 27, 2012 AB RX No 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

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