Bausch Health Files Patent Infringement Lawsuit Against Norwich Pharmaceuticals

Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC) and its gastroenterology business, Salix Pharmaceuticals, have announced a patent infringement lawsuit against Norwich Pharmaceuticals, Inc. This legal action, filed in the U.S. District Court for the District of New Jersey, follows a Notice of Paragraph IV Certification from Norwich. The certification pertains to an amendment to an Abbreviated New Drug Application (ANDA) seeking FDA approval for a generic version of XIFAXAN® (rifaximin) 550 mg tablets used for treating diarrhea-predominant irritable bowel syndrome (IBS-D).

Bausch Health continues to defend its intellectual property rights for XIFAXAN®. A previous lawsuit ended with a 2022 ruling that barred Norwich's initial ANDA for XIFAXAN® 550 mg until October 2029, a decision later upheld on appeal. Since then, Bausch Health secured additional patents for the innovative treatment.

The company emphasizes its dedication to protecting its patents and ensuring patient safety, maintaining that continued access to XIFAXAN® is vital for patients' health outcomes.