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Last Updated: April 19, 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-two 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 and one 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.

Summary for ethinyl estradiol

US Patents:	17
Tradenames:	232
Applicants:	57
NDAs:	301
Drug Master File Entries:	16
Raw Ingredient (Bulk) Api Vendors:	85
Clinical Trials:	222
Patent Applications:	6,692
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for ethinyl estradiol
DailyMed Link:	ethinyl estradiol at DailyMed

Drug Prices for ethinyl estradiol

See drug prices for ethinyl estradiol

Recent Clinical Trials for ethinyl estradiol

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

Sponsor	Phase
Parexel	Phase 1
Lupin Research Inc	Phase 2
Women's Hospital School Of Medicine Zhejiang University	Phase 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 Trial	0.03MG,0.01MG; 0.15MG,N/A	TABLET;ORAL
⤷ Try a Trial	⤷ Try a Trial	0.02MG,0.15MG;0.025MG,0.15MG;0.03MG,0.15MG;0.01MG,N/A	TABLET;ORAL
⤷ Try a Trial	⤷ Try a Trial	0.01MG,0.01MG;1MG,N/A	TABLET;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

Estrogens

US Patents and Regulatory Information for ethinyl estradiol

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Amneal	ETHINYL ESTRADIOL AND NORELGESTROMIN	ethinyl estradiol; norelgestromin	FILM, EXTENDED RELEASE;TRANSDERMAL	213950-001	Feb 25, 2021	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Mylan Labs Ltd	NORETHINDRONE AND ETHINYL ESTRADIOL	ethinyl estradiol; norethindrone	TABLET;ORAL-28	200897-001	May 11, 2015		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Gd Searle Llc	DEMULEN 1/35-28	ethinyl estradiol; ethynodiol diacetate	TABLET;ORAL-28	018160-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Allergan	BREVICON 21-DAY	ethinyl estradiol; norethindrone	TABLET;ORAL-21	017566-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Lupin Ltd	MINZOYA	ethinyl estradiol; levonorgestrel	TABLET;ORAL	217087-001	Feb 15, 2024	AB3	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Xiromed	ESTARYLLA	ethinyl estradiol; norgestimate	TABLET;ORAL-28	090794-001	Jan 30, 2013	AB	RX	No	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

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