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: 1 brand, 3 generics; first approved Mar 14, 2011; generic available.

Generic available

Generic status & protection

Generic available — 3 ANDA applications approved.

Brands (NDA)

Generics (ANDA)

Listed patents

Presentations

Originator applications

Brand (NDA) products

GADAVISTRLDRS

BAYER HLTHCARENDA 20127720136 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
4.5354GM/7.5ML (604.72MG/ML)	SOLUTION	INTRAVENOUS	Rx	AP
6.0472GM/10ML (604.72MG/ML)	SOLUTION	INTRAVENOUS	Rx	AP
9.0708GM/15ML (604.72MG/ML)	SOLUTION	INTRAVENOUS	Rx	AP
18.1416GM/30ML (604.72MG/ML)	SOLUTION	INTRAVENOUS	Rx	AP
39.3068GM/65ML (604.72MG/ML)	SOLUTION	INTRAVENOUS	Rx	AP
1.20944GM/2ML (604.72MG/ML)	SOLUTION	INTRAVENOUS	Rx	AP

Abbreviated applications

Generic (ANDA) products (3)

GADOBUTROL

ZENARAANDA 21914620266 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1.20944GM/2ML (604.72MG/ML)	SOLUTION	INTRAVENOUS	Rx	AP
4.5354GM/7.5ML (604.72MG/ML)	SOLUTION	INTRAVENOUS	Rx	AP
6.0472GM/10ML (604.72MG/ML)	SOLUTION	INTRAVENOUS	Rx	AP
9.0708GM/15ML (604.72MG/ML)	SOLUTION	INTRAVENOUS	Rx	AP
18.1416GM/30ML (604.72MG/ML)	SOLUTION	INTRAVENOUS	Rx	AP
39.3068GM/65ML (604.72MG/ML)	SOLUTION	INTRAVENOUS	Rx	AP

GADOBUTROL

HAINAN POLY PHARMANDA 21748020256 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
4.5354GM/7.5ML (604.72MG/ML)	SOLUTION	INTRAVENOUS	Rx	AP
9.0708GM/15ML (604.72MG/ML)	SOLUTION	INTRAVENOUS	Rx	AP
1.20944GM/2ML (604.72MG/ML)	SOLUTION	INTRAVENOUS	Rx	AP
6.0472GM/10ML (604.72MG/ML)	SOLUTION	INTRAVENOUS	Rx	AP
18.1416GM/30ML (604.72MG/ML)	SOLUTION	INTRAVENOUS	Rx	AP
39.3068GM/65ML (604.72MG/ML)	SOLUTION	INTRAVENOUS	Rx	AP

GADOBUTROL

HENGRUI PHARMAANDA 21608120226 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
18.1416GM/30ML (604.72MG/ML)	SOLUTION	INTRAVENOUS	Rx	AP
39.3068GM/65ML (604.72MG/ML)	SOLUTION	INTRAVENOUS	Rx	AP
1.20944GM/2ML (604.72MG/ML)	SOLUTION	INTRAVENOUS	Rx	AP
4.5354GM/7.5ML (604.72MG/ML)	SOLUTION	INTRAVENOUS	Rx	AP
6.0472GM/10ML (604.72MG/ML)	SOLUTION	INTRAVENOUS	Rx	AP
9.0708GM/15ML (604.72MG/ML)	SOLUTION	INTRAVENOUS	Rx	AP

Orange Book patent file

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.

FDA approval span

Approval history

First approval

Mar 14, 2011

15 yr 7 mo ago

Most recent approval

Jun 08, 2026

1 mo ago

Approvals span 2011–2026 across 4 FDA applications.

Brand (NDA) 125%

Generic (ANDA) 375%

Gadobutrol — frequently asked questions

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

Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

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