Is there a generic for Gadobenate dimeglumine?

The FDA Orange Book does not currently list an approved generic (ANDA) for Gadobenate dimeglumine. It is available as 2 brand (NDA) applications.

What is the reference-listed drug for Gadobenate dimeglumine?

MULTIHANCE (NDA 021357, BRACCO) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Gadobenate dimeglumine are approved?

Gadobenate dimeglumine is approved in the following dosage form: injectable.

FDA Orange Book · active-ingredient family

Gadobenate dimeglumine

Gadobenate dimeglumine is approved in 2 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:MULTIHANCE · NDA 021357

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · injectable

Product	Applicant	Application	TE	Approved
MULTIHANCERLD×4	BRACCO	NDA 021357	—	Nov 23, 2004
MULTIHANCE MULTIPACKRLD×2	BRACCO	NDA 021358	—	Nov 23, 2004

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.

Gadobenate dimeglumine — frequently asked questions

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

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.

Book a Demo