Is there a generic for Gadobutrol?

Yes. The FDA Orange Book lists 3 approved generic (ANDA) applications for Gadobutrol, referencing the brand GADAVIST. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Gadobutrol?

GADAVIST (NDA 201277, BAYER HLTHCARE) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Gadobutrol are approved?

Gadobutrol is approved in the following dosage form: solution.

FDA Orange Book · active-ingredient family

Gadobutrol

Gadobutrol is approved as 1 brand and 3 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:GADAVIST · NDA 201277

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · solution

Product	Applicant	Application	TE	Approved
GADAVISTRLD×6	BAYER HLTHCARE	NDA 201277	AP	Dec 18, 2013

Generic (ANDA) products (3)

Product	Applicant	Application	TE	Approved
GADOBUTROL×6	ZENARA	ANDA 219146	AP	Jun 08, 2026
GADOBUTROL×6	HAINAN POLY PHARM	ANDA 217480	AP	Apr 16, 2025
GADOBUTROL×6	HENGRUI PHARMA	ANDA 216081	AP	Nov 17, 2022

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.

Gadobutrol — frequently asked questions

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

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