Is there a generic for Gadoteridol?

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

What is the reference-listed drug for Gadoteridol?

PROHANCE MULTIPACK (NDA 021489, BRACCO) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Gadoteridol are approved?

Gadoteridol is approved in the following dosage form: injectable.

FDA Orange Book · active-ingredient family

Gadoteridol

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

Reference-listed drug:PROHANCE MULTIPACK · NDA 021489

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · injectable

Product	Applicant	Application	TE	Approved
PROHANCE MULTIPACKRLD	BRACCO	NDA 021489	—	Oct 09, 2003
PROHANCERLD	BRACCO	NDA 020131	AP	Nov 16, 1992

Generic (ANDA) products (1)

Product	Applicant	Application	TE	Approved
GADOTERIDOL	HAINAN POLY	ANDA 218749	AP	Feb 11, 2025

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.

Gadoteridol — frequently asked questions

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

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