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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 Lachman Consulting Services, Inc. filed this suitability petition under Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting that the FDA declare Baclofen Orally Disintegrating Tablets, 5 mg suitable for submission as an Abbreviated New Drug Application, representing a change i	Suitability	2026-04-28	Open	Lachman Consulting Services, Inc.
Citizen Petition from Pharmobedient Consulting, LLC FDA-2023-P-4587 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whether the Reference Listed Drug KEMSTRO (baclofen) orally disintegrating tablet, 10 mg and 20 mg, NDA 021589, was withdrawn from commercial dist	505(q)	2023-10-18	Granted	Pharmobedient Consulting, LLC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

No clinical trials found on ClinicalTrials.gov for this drug

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