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MAGNEVIST

NDA

GADOPENTETATE DIMEGLUMINE | N019596 | BAYER HEALTHCARE PHARMACEUTICALS INC

1 strength0 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

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition From Chrai Associates, Inc. FDA-2015-P-0335 · 6 docket documents Chrai Associates, Inc. filed this ANDA Suitability Petition under section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting FDA approval to submit an Abbreviated New Drug Application for gadopentetate dimeglumine injection in 15 mL and 20 mL Pharmacy Bulk Packages at a concentration	Other	2015-02-02	Withdrawn	Chrai Associates, Inc.

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

24 trials from ClinicalTrials.gov, 15 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Gadobutrol Magnevist-controlled Body Study NCT01050829	Phase 3	Completed	Bayer	370	2010-01 → 2011-04
Magnetic Resonance Imaging of Interscalene Plexus Block NCT02175069	Phase 4	Completed	Paracelsus Medical University	30	2013-12 → 2014-07
Magnevist® Injection Enhanced MRA Compared to Non Contrast MRA for the Detection of Structural Abnormalities of the Aortic Arch and Cerebral Branches NCT00310609	Phase 3	Completed	Bayer	123	2003-12 → 2004-10
Evaluating Sunitinib Therapy in Renal Cell Carcinoma Using F-18 FDG PET/CT and DCE MRI NCT00537056	N/A	Completed	Stanford University	17	2007-10 → 2012-04
Multihance at 3 Tesla (3T) in Brain Tumors NCT00395863	Phase 4	Completed	Bracco Diagnostics, Inc	46	2006-11 → 2008-03
Magnevist (SH L 451A) Intra-individual Dose Comparison Study in Magnetic Resonance Angiography NCT00652418	Phase 2	Completed	Bayer	12	2004-07 → 2004-10
Magnevist® Injection Enhanced MRA at Two Dose Levels Compared to Non Contrast MRA for the Detection of Structural Abnormalities of the Infrarenal Aorta and Peripheral Arteries NCT00185276	Phase 3	Completed	Bayer	365	2003-03 → 2004-08
Combined 18F-NaF/18F-FDG PET/MRI for Detection of Skeletal Metastases NCT00375830	Phase 2	Completed	Stanford University	114	2006-01 → 2019-03-14
MRI and CT Scans to Evaluate Invasive Cervical Cancer Before Treating Patients NCT00004936	N/A	Completed	American College of Radiology Imaging Network	—	2000-04 → 2002-10
Cardiovascular Safety Study of Magnevist® Injection at Two Dose Levels and Two Injection Rates in Normal Subjects NCT00310596	Phase 1	Completed	Bayer	71	2004-01 → 2004-03

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

Medicare Part B Spending

CMS physician-administered drug spending for Magnevist (2024)

Total Spending

$1.1M

Total Claims

46,545

Beneficiaries

41,908

ASP Price

$1.51

Spending Trend

$1.9M(2019)→$1.4M(2020)→$1.5M(2021)→$1.3M(2022)→$1.2M(2023)→$1.1M(2024)

YoY Change:-3.8%

5yr CAGR:-0.6%

HCPCS: A9579 — Injection, gadolinium-based magnetic resonance contrast agent, not otherwise specified (nos), per ml

Source: CMS Medicare Part B Spending by Drug (2024). Shows physician-administered drug costs.

API Supply Chain2 active DMFs

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

SEVEN STAR PHARMACEUTICAL CO LTDGADOPENTETATE DIMEGLUMINE

DMF 266472012

BIOPHORE INDIA PHARMACEUTICALS PVT LTDGADOPENTETATE DIMEGLUMINE

DMF 386152023

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

Approval Letters

12 letters from Drugs@FDA

Date	Submission	Document
Jul 26, 2018	SUPPL -65	View Letter (PDF)
Jul 26, 2018	SUPPL -64	View Letter (PDF)
Jun 20, 2018	SUPPL -63	View Letter (PDF)
Jun 12, 2014	SUPPL -57	View Letter (PDF)
Oct 18, 2013	SUPPL -56	View Letter (PDF)
Apr 2, 2012	SUPPL -51	View Letter (PDF)
Dec 22, 2010	SUPPL -49	View Letter (PDF)
Aug 31, 2010	SUPPL -34	View Letter (PDF)
May 29, 2009	SUPPL -45	View Letter (PDF)
Sep 6, 2007	SUPPL -43	View Letter (PDF)
Sep 15, 2006	SUPPL -39	View Letter (PDF)
Jan 26, 2005	SUPPL -33	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 469.01MG/ML

RLD

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Jun 2, 1988

No patent or exclusivity listings for this strength.