Is there a generic for Ibutilide fumarate?

Yes. The FDA Orange Book lists 4 approved generic (ANDA) applications for Ibutilide fumarate, referencing the brand CORVERT. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Ibutilide fumarate?

CORVERT (NDA 020491, PFIZER) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Ibutilide fumarate are approved?

Ibutilide fumarate is approved in the following dosage form: injectable.

FDA Orange Book · active-ingredient family

Ibutilide fumarate

Ibutilide fumarate is approved as 1 brand and 4 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:CORVERT · NDA 020491

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · injectable

Product	Applicant	Application	TE	Approved
CORVERTRLD	PFIZER	NDA 020491	AP	Dec 28, 1995

Generic (ANDA) products (4)

Product	Applicant	Application	TE	Approved
IBUTILIDE FUMARATE	AVET LIFESCIENCES	ANDA 204146	AP	Apr 01, 2024
IBUTILIDE FUMARATE	LUITPOLD	ANDA 090240	—	Jan 11, 2010
IBUTILIDE FUMARATE	MYLAN INSTITUTIONAL	ANDA 090924	—	Jan 11, 2010
IBUTILIDE FUMARATE	PHARMOBEDIENT	ANDA 090643	AP	Jan 11, 2010

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.

Ibutilide fumarate — frequently asked questions

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

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