Is there a generic for Avanafil?

Yes. The FDA Orange Book lists 1 approved generic (ANDA) application for Avanafil, referencing the brand STENDRA. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Avanafil?

STENDRA (NDA 202276, VIVUS LLC) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Avanafil are approved?

Avanafil is approved in the following dosage form: tablet.

FDA Orange Book · active-ingredient family

Avanafil

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

Reference-listed drug:STENDRA · NDA 202276

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · tablet

Product	Applicant	Application	TE	Approved
STENDRARLD×3	VIVUS LLC	NDA 202276	AB	Apr 27, 2012

Generic (ANDA) products (1)

Product	Applicant	Application	TE	Approved
AVANAFIL×3	HETERO LABS LTD V	ANDA 209266	AB	Jun 14, 2024

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.

Avanafil — frequently asked questions

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

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