Viewing data from:

BACLOFEN

ANDA

BACLOFEN | A214445 | RUBICON RESEARCH LTD

2 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: OZOBAX DS

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
METACEL PHARMACEUTICALS LLC v. RUBICON RESEARCH PRIVATE LIMITED 2:2025cv01382 1 patentANDA 214445baclofen	D.N.J.	2025-02-20	Terminated 2025-05-02	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

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
Feb 10, 2025	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 5MG/5ML

0 patents0 exclusivities▴

SOLUTION;ORAL | Approved: Dec 6, 2024

No patent or exclusivity listings for this strength.

#002 — 10MG/5ML

0 patents0 exclusivities▾

SOLUTION;ORAL | Approved: Jun 3, 2025