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GADAVIST

NDA

GADOBUTROL | N201277 | BAYER HEALTHCARE PHARMACEUTICALS INC

6 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

3 trials from ClinicalTrials.gov, 3 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
A Study of a Gadolinium-Based Contrast Agent (GBCA) for Adults Undergoing Magnetic Resonance Imaging (MRI) for Known or Highly Suspected Body Parts (Non-Central Nervous System) Lesions NCT07275723	Phase 3	Completed	Shanghai Shengdi Pharmaceutical Co., Ltd	309	2025-11-14 → 2026-06-09
Intramyocardial Haemorrhage in Patients With Primary STEMI NCT03677466	N/A	Completed	Tomsk National Research Medical Center of the Russian Academy of Sciences	60	2018-01-25 → 2019-03-20
A Study of a Gadolinium-Based Contrast Agent (GBCA) for Adults Undergoing Magnetic Resonance Imaging (MRI) for Known or Highly Suspected Central Nervous System (CNS) Lesions NCT07275814	Phase 3	Completed	Shanghai Shengdi Pharmaceutical Co., Ltd	250	2025-11-17 → 2026-06-17

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Medicare Part B Spending

CMS physician-administered drug spending for Gadavist (2023)

Total Spending

$6.7M

Total Claims

254,770

Beneficiaries

218,160

ASP Price

—

HCPCS: A9585 — Injection, gadobutrol, 0.1 ml

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

API Supply Chain9 active DMFs1 inactive

9 active API suppliers hold Drug Master Files for this ingredient.

BAYER AGGADOBUTROL

DMF 130611998

BIOPHORE INDIA PHARMACEUTICALS PVT LTDGADOBUTROL MONOHYDRATE

DMF 334202019

JIANGSU HENGRUI PHARMACEUTICALS CO LTDGADOBUTROL USP

DMF 348322020

ST PHARM CO LTDGADOBUTROL MONOHYDRATE

DMF 356622021

FORMOSA LABORATORIES INCGADOBUTROL MONOHYDRATE

DMF 366602021

MSN LIFE SCIENCES PRIVATE LTDGADOBUTROL MONOHYDRATE USP

DMF 369962022

VIWIT PHARMACEUTICAL CO LTDGADOBUTROL

DMF 390942023

ANHUI POLY PHARM CO LTDGADOBUTROL USP

DMF 391492023

BEIJING BEILU PHARMACEUTICAL CO LTDGADOBUTROL

DMF 405332024

SICHUAN RENAN PHARMACEUTICAL CO LTDInactiveGADOBUTROL

DMF 385792023

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

16 letters from Drugs@FDA

Date	Submission	Document
Feb 18, 2026	SUPPL -25	View Letter (PDF)
Mar 6, 2025	SUPPL -28	View Letter (PDF)
Jul 24, 2024	SUPPL -26	View Letter (PDF)
Jan 29, 2024	SUPPL -23	View Letter (PDF)
Jul 31, 2020	SUPPL -18	View Letter (PDF)
Jul 15, 2019	SUPPL -17	View Letter (PDF)
Nov 15, 2018	SUPPL -16	View Letter (PDF)
Jul 30, 2018	SUPPL -15	View Letter (PDF)
May 1, 2018	SUPPL -13	View Letter (PDF)
Apr 28, 2016	SUPPL -11	View Letter (PDF)
Aug 3, 2015	SUPPL -10	View Letter (PDF)
Dec 31, 2014	SUPPL -8	View Letter (PDF)
Jun 12, 2014	SUPPL -7	View Letter (PDF)
Oct 18, 2013	SUPPL -3	View Letter (PDF)
Mar 26, 2012	SUPPL -1	View Letter (PDF)
Mar 16, 2011	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (6)

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#001 — 4.5354GM/7.5ML (604.72MG/ML)

RLDAP

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