Viewing data from:

OMNIPAQUE 240

NDA

IOHEXOL | N020608 | GE HEALTHCARE

3 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

API Supply Chain3 active DMFs3 inactive

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

ZHEJIANG STARRY PHARMACEUTICAL CO LTDIOHEXOL USP

DMF 360382021

DIVI'S LABOTATORIES LTDIOHEXOL

DMF 381952023

SUZHOU RYWAY BIOTECH CO LTDIOHEXOL

DMF 423822025

ZHEJIANG STARRY PHARMACEUTICAL CO LTDInactiveIOHEXOL

DMF 225352009

HOVIONE FARMACIENCIA SAInactiveIOHEXOL

DMF 231482009

INTERPHARMA PRAHA ASInactiveIOHEXOL DRUG SUBSTANCE, FOR ORAL PRODUCTS

DMF 266412013

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

Approval Letters

10 letters from Drugs@FDA

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 51.8%

0 patents0 exclusivities▴

SOLUTION;INJECTION, ORAL, RECTAL | Approved: Oct 24, 1995

No patent or exclusivity listings for this strength.

#002 — 64.7%

0 patents0 exclusivities▾

SOLUTION;INJECTION, ORAL, RECTAL | Approved: Oct 24, 1995

#003 — 75.5%

0 patents0 exclusivities▾

SOLUTION;INJECTION, ORAL | Approved: Oct 24, 1995