Viewing data from:

MAGNEVIST

NDA

GADOPENTETATE DIMEGLUMINE | N021037 | 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

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

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

13 letters from Drugs@FDA

Source: Drugs@FDA application documents.

Products (1)

#001 — 469.01MG/ML

RLD

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Mar 10, 2000

No patent or exclusivity listings for this strength.