Is there a generic for Ethinyl estradiol?

The FDA Orange Book does not currently list an approved generic (ANDA) for Ethinyl estradiol. It is available as 3 brand (NDA) applications.

What is the reference-listed drug for Ethinyl estradiol?

ESTINYL (NDA 005292, SCHERING) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Ethinyl estradiol are approved?

Ethinyl estradiol is approved in the following dosage form: tablet.

FDA Orange Book · active-ingredient family

Ethinyl estradiol

Ethinyl estradiol is approved in 3 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:ESTINYL · NDA 005292

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · tablet

Product	Applicant	Application	TE	Approved
ESTINYL×3	SCHERING	NDA 005292	—	Approved Prior to Jan 1, 1982
FEMINONE	PHARMACIA AND UPJOHN	NDA 016649	—	Approved Prior to Jan 1, 1982
LYNORAL×2	ORGANON USA INC	NDA 005490	—	Approved Prior to Jan 1, 1982

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Ethinyl estradiol — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

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