Viewing data from:

MULTIHANCE

NDA

GADOBENATE DIMEGLUMINE | N021357 | BRACCO DIAGNOSTICS INC

4 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part B Spending

CMS physician-administered drug spending for Multihance (2023)

Total Spending

$888K

Total Claims

36,410

Beneficiaries

33,120

ASP Price

—

HCPCS: A9577 — Injection, gadobenate dimeglumine (multihance), per ml

Source: CMS Medicare Part B Spending by Drug (2023). Shows physician-administered drug costs.

Approval Letters

16 letters from Drugs@FDA

Date	Submission	Document
Mar 6, 2025	SUPPL -28	View Letter (PDF)
Aug 16, 2024	SUPPL -26	View Letter (PDF)
Jul 24, 2024	SUPPL -27	View Letter (PDF)
Jan 29, 2024	SUPPL -25	View Letter (PDF)
Nov 14, 2018	SUPPL -18	View Letter (PDF)
May 1, 2018	SUPPL -16	View Letter (PDF)
May 1, 2018	SUPPL -17	View Letter (PDF)
Jan 26, 2018	SUPPL -14	View Letter (PDF)
Sep 19, 2017	SUPPL -15	View Letter (PDF)
Aug 1, 2013	SUPPL -13	View Letter (PDF)
Jul 9, 2012	SUPPL -11	View Letter (PDF)
Dec 22, 2010	SUPPL -9	View Letter (PDF)
Mar 22, 2010	SUPPL -6	View Letter (PDF)
Nov 10, 2009	SUPPL -4	View Letter (PDF)
Sep 6, 2007	SUPPL -3	View Letter (PDF)
Dec 2, 2004	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#001 — 2.645GM/5ML (529MG/ML)

RLD

0 patents0 exclusivities▴

INJECTABLE;INTRAVENOUS | Approved: Nov 23, 2004

No patent or exclusivity listings for this strength.

#002 — 5.29GM/10ML (529MG/ML)

RLD

0 patents0 exclusivities▾

INJECTABLE;INTRAVENOUS | Approved: Nov 23, 2004

#003 — 7.935GM/15ML (529MG/ML)

RLD

0 patents0 exclusivities▾

INJECTABLE;INTRAVENOUS | Approved: Nov 23, 2004

#004 — 10.58GM/20ML (529MG/ML)

RLD

0 patents0 exclusivities▾

INJECTABLE;INTRAVENOUS | Approved: Nov 23, 2004