Is there a generic for Toremifene citrate?

Yes. The FDA Orange Book lists 2 approved generic (ANDA) applications for Toremifene citrate, referencing the brand FARESTON. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Toremifene citrate?

FARESTON (NDA 020497, KYOWA KIRIN) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Toremifene citrate are approved?

Toremifene citrate is approved in the following dosage form: tablet.

FDA Orange Book · active-ingredient family

Toremifene citrate

Toremifene citrate is approved as 1 brand and 2 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:FARESTON · NDA 020497

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · tablet

Product	Applicant	Application	TE	Approved
FARESTONRLD	KYOWA KIRIN	NDA 020497	—	May 29, 1997

Generic (ANDA) products (2)

Product	Applicant	Application	TE	Approved
TOREMIFENE CITRATE	MSN	ANDA 212818	AB	Aug 18, 2020
TOREMIFENE CITRATE	RISING	ANDA 208813	AB	Dec 04, 2018

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.

Toremifene citrate — frequently asked questions

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

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