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KEMSTRO

NDA

BACLOFEN | N021589 | UCB INC

2 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

2 petitions (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Suitability Petition from Lachman Consulting Services, Inc. FDA-2026-P-4665 · 6 docket documents Lachman Consulting Services, Inc. filed this suitability petition under Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting that FDA declare Baclofen Orally Disintegrating Tablets, 5 mg suitable for submission as an ANDA. The petitioner seeks to introduce a new 5 mg strength b	Suitability	2026-04-28	Open	Lachman Consulting Services, Inc.
Citizen Petition from Pharmobedient Consulting, LLC FDA-2023-P-4587 · 4 docket documents Pharmobedient Consulting, LLC filed a citizen petition under Section 505(j) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA determine whether the Reference Listed Drug KEMSTRO (baclofen) orally disintegrating tablet, 10 mg and 20 mg, NDA 021589, was withdrawn from commercial dist	505(q)	2023-10-18	Granted	Pharmobedient Consulting, LLC

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

Clinical Trials

88 trials from ClinicalTrials.gov, 60 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Efficacy and Safety of Baclofen for Maintenance of Abstinence in Alcohol Dependent Patients NCT01738282	Phase 3	Completed	Ethypharm	316	2012-12 → 2014-07
Efficacy and Safety of High Dose Baclofen for Alcohol Dependence NCT01980706	Phase 2	Completed	University of North Carolina, Chapel Hill	120	2013-12-12 → 2017-10-26
Dose Escalation Study of Intravenous Baclofen in Healthy Adult Volunteers NCT01931319	Phase 1	Completed	University of Minnesota	39	2014-01 → 2014-06
A Study to Examine the, Safety, Tolerability and Pharmacokinetics Co-Administered Baclofen and Memantine in Obese and Lean, Otherwise Healthy Adults NCT02001584	Phase 1	Completed	Gedeon Richter Plc.	—	— → 2014-05
A Placebo Controlled Trial With Baclofen for the Treatment of GERD Patients With Incomplete PPI Response NCT03835442	N/A	Completed	Universitaire Ziekenhuizen KU Leuven	60	2010-01 → 2019-01
IPX056 in Subjects With Established Spasticity Resulting From Multiple Sclerosis NCT00488839	Phase 3	Completed	Impax Laboratories, LLC	173	2007-06 → 2008-05
Intrathecal Administration of Baclofen (ITB) to Cerebral Palsy Patients With Therapy-Resistant Spasticity NCT00221611	Phase 2	Completed	University Hospital, Ghent	80	2000-01 → 2006-08
Baclofen Treatment of Ataxia Telangiectasia NCT00640003	Early Phase 1	Completed	Johns Hopkins University	10	2007-04 → 2011-02
Intrathecal Baclofen (ITB) Bolus on Neuropathic Pain (NP). Preliminary Study.NCT02705950	N/A	Completed	Institut Guttmann	12	2014-12 → 2017-08
Baclofen in the Treatment of Alcohol Dependence With or Without Alcoholic Liver Disease NCT01711125	Phase 3	Completed	South West Sydney Local Health District	104	2013-03 → 2017-06

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

API Supply Chain12 active DMFs6 inactive

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

FINE CHEMICALS CORP PTY LTDBACLOFEN

DMF 64211986

PCASBACLOFEN

DMF 70771987

EXCELLA GMBH AND CO KGBACLOFEN

DMF 73111988

ZAKLADY FARMACEUTYCZNE POLPHARMA SABACLOFEN

DMF 180142005

MATRIX PHARMACORP PRIVATE LTDBACLOFEN USP

DMF 182202005

PIRAMAL PHARMA LTDBACLOFEN

DMF 284552014

UNICHEM LABORATORIES LTDBACLOFEN USP

DMF 324312018

COHANCE LIFESCIENCES LTDBACLOFEN USP

DMF 333022018

FINE CHEMICALS CORP PTY LTDBACLOFEN (PROCESS 2)

DMF 352242020

MEDILUX LABORATORIES PVT LTDBACLOFEN

DMF 356542021

MANKIND PHARMA LTDBACLOFEN USP

DMF 370112022

VIYASH LIFE SCIENCES PRIVATE LTDBACLOFEN USP

DMF 385322023

RESOLUTION CHEMICALS LTDInactiveBACLOFEN

DMF 73681988

ICFI SPAInactiveBACLOFEN

DMF 74991988

RESOLUTION CHEMICALS LTDInactiveBACLOFEN RAW MATERIAL

DMF 77241988

ERREGIERRE SPAInactiveBACLOFEN

DMF 78171988

RESOLUTION CHEMICALS LTDInactiveBACLOFEN

DMF 98371992

PFC ITALIANA SRL DIV ALFA CHEMICALS ITALIANAInactiveBACLOFEN

DMF 124381997

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Nov 5, 2003	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

TABLET, ORALLY DISINTEGRATING;ORAL | Approved: Oct 30, 2003

No patent or exclusivity listings for this strength.

#002 — 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

TABLET, ORALLY DISINTEGRATING;ORAL | Approved: Oct 30, 2003