Viewing data from:

TALWIN 50

NDA

PENTAZOCINE HYDROCHLORIDE | N016732 | SANOFI AVENTIS US LLC

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 DMFs2 inactive

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

INDUSTRIALE CHIMICA SRLPENTAZOCINE HYDROCHLORIDE

DMF 139831999

FIS FABBRICA ITALIANA SINTETICI SPAPENTAZOCINE

DMF 302142016

MALLINCKRODT INCInactivePENTAZOCINE HYDROCHLORIDE USP

DMF 128711998

OLON SPAInactivePENTAZOCINE HYDROCHLORIDE

DMF 183452005

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

Products (1)

#001 — EQ 50MG BASE

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.