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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

2 petitions from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition fromLachman Consultant Services, Inc. FDA-2011-P-0460 · 4 docket documents Lachman Consultant Services, Inc. filed this petition requesting that the FDA determine whether Talwin Compound (aspirin and pentazocine hydrochloride) Tablets, 325 mg/12.5 mg, NDA 16-891 by Sanofi Aventis, was voluntarily withdrawn from marketing for safety or effectiveness reasons under 21 CFR 314	505(q)	2011-06-26	Denied	—
Lachman Consultant Services, Inc. - Citizen Petition FDA-2011-P-0459 · 3 docket documents Lachman Consultant Services, Inc. filed this citizen petition on behalf of a client requesting that the FDA declare Pentazocine Hydrochloride and Acetaminophen Tablets in 12.5 mg/325 mg and 25 mg/325 mg strengths suitable for submission as an ANDA, with Watson Pharma's 25 mg/650 mg product (ANDA 74-	Other	2011-06-23	Partially Denied	—

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

Clinical Trials

5 trials from ClinicalTrials.gov, 4 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
The Impact of Local Analgesia for Postoperative Analgesia in Posterior Thoracolumbar Operation NCT01872494	Phase 4	Completed	Guangzhou General Hospital of Guangzhou Military Command	71	2013-05 → 2014-02
Effects of Pentazocine Versus Lorazepam on Manic Symptoms NCT00431184	Phase 2	Completed	Mclean Hospital	19	2007-01 → 2011-03
Effects of a Kappa Agonist on Hot Flashes in Menopausal Women NCT02070718	Phase 1	Completed	University of Washington	12	2013-01 → 2013-07
Effects of Pentazocine on Manic Symptoms NCT00125931	Phase 2	Completed	Mclean Hospital	10	2005-09 → 2008-12
The Feasibility of Different Doses of Etomidate Admixed With Propofol in Induced Abortion: A Randomized, Double Blind Controlled Trial NCT02208596	Phase 4	UNKNOWN	Third Affiliated Hospital of Zhengzhou University	150	2014-09 → 2015-02

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

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.