Viewing data from:

NICLOCIDE

NDA

NICLOSAMIDE | N018669 | BAYER PHARMACEUTICALS CORP

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 Chain1 active DMF3 inactive

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

OLON SPANICLOSAMIDE

DMF 345972020

US COTTON LLCInactiveNICLOSAMIDE

DMF 41461981

BAYER AGInactiveNICLOSAMIDE ANHYDROUS DRUG SUBSTANCE

DMF 252732011

BAYER AGInactiveNICLOSAMIDE 500MG TABLET

DMF 252742011

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

Products (1)

#001 — 500MG

0 patents0 exclusivities▴

TABLET, CHEWABLE;ORAL | Approved: May 14, 1982

No patent or exclusivity listings for this strength.