Is there a generic for Trifluridine?

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

What is the reference-listed drug for Trifluridine?

VIROPTIC (NDA 018299, MONARCH PHARMS) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Trifluridine are approved?

Trifluridine is approved in the following dosage form: solution/drops.

FDA Orange Book · active-ingredient family

Trifluridine

Trifluridine 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:VIROPTIC · NDA 018299

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · solution/drops

Product	Applicant	Application	TE	Approved
VIROPTICRLD	MONARCH PHARMS	NDA 018299	AT	Approved Prior to Jan 1, 1982

Generic (ANDA) products (2)

Product	Applicant	Application	TE	Approved
TRIFLURIDINE	HIKMA	ANDA 205438	—	Jul 28, 2017
TRIFLURIDINE	SANDOZ	ANDA 074311	AT	Oct 06, 1995

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.

Trifluridine — frequently asked questions

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

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