Is there a generic for Gadoterate meglumine?

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

What is the reference-listed drug for Gadoterate meglumine?

DOTAREM (NDA 204781, GUERBET) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Gadoterate meglumine are approved?

Gadoterate meglumine is approved in the following dosage form: solution.

FDA Orange Book · active-ingredient family

Gadoterate meglumine

Gadoterate meglumine 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:DOTAREM · NDA 204781

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · solution

Product	Applicant	Application	TE	Approved
DOTAREMRLD×5	GUERBET	NDA 204781	AP	Mar 31, 2017

Generic (ANDA) products (3)

Product	Applicant	Application	TE	Approved
GADOTERATE MEGLUMINE×5	HAINAN POLY	ANDA 218073	AP	Jun 17, 2024
GADOTERATE MEGLUMINE×5	HENGRUI PHARMA	ANDA 215304	—	Apr 11, 2022
CLARISCAN×5	GE HEALTHCARE	ANDA 210016	AP	Nov 24, 2020

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.

Gadoterate meglumine — frequently asked questions

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

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