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EOVIST

NDA

GADOXETATE DISODIUM | N022090 | BAYER HEALTHCARE PHARMACEUTICALS INC

2 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

1 trial from ClinicalTrials.gov, 1 active

Trial	Phase	Status	Sponsor	Enrollment	Dates
Contrast-enhanced MRI in Detecting Benign and Malignant Liver Lesions NCT02156739	N/A	Active	M.D. Anderson Cancer Center	100	2014-10-13 → 2028-06-01

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

Medicare Part B Spending

CMS physician-administered drug spending for Eovist (2023)

Total Spending

$1.2M

Total Claims

8,683

Beneficiaries

6,881

ASP Price

—

HCPCS: A9581 — Injection, gadoxetate disodium, 1 ml

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

API Supply Chain1 active DMF1 inactive

1 active API supplier hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

BIOPHORE INDIA PHARMACEUTICALS PVT LTDGADOXETATE DISODIUM

DMF 418102025

SICHUAN RENAN PHARMACEUTICAL CO LTDInactiveGADOXETATE DISODIUM

DMF 396602024

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 -27	View Letter (PDF)
Aug 16, 2024	SUPPL -23	View Letter (PDF)
Jul 24, 2024	SUPPL -26	View Letter (PDF)
Jan 31, 2024	SUPPL -24	View Letter (PDF)
Dec 29, 2021	SUPPL -20	View Letter (PDF)
Dec 2, 2021	SUPPL -19	View Letter (PDF)
Nov 15, 2018	SUPPL -16	View Letter (PDF)
Jul 30, 2018	SUPPL -15	View Letter (PDF)
May 1, 2018	SUPPL -14	View Letter (PDF)
Apr 1, 2015	SUPPL -11	View Letter (PDF)
Oct 18, 2013	SUPPL -8	View Letter (PDF)
Nov 21, 2011	SUPPL -5	View Letter (PDF)
Dec 22, 2010	SUPPL -4	View Letter (PDF)
Nov 19, 2009	SUPPL -2	View Letter (PDF)
Jul 15, 2008	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 1.8143GM/10ML (181.43MG/ML)

RLD

0 patents0 exclusivities▴

SOLUTION;INTRAVENOUS | Approved: Jul 3, 2008

No patent or exclusivity listings for this strength.

#002 — 2.72145GM/15ML (181.43MG/ML)

RLD

0 patents0 exclusivities▾

SOLUTION;INTRAVENOUS | Approved: Feb 4, 2013