Bausch Health Files Patent Lawsuit Against Amneal Pharmaceuticals Over Generic Version of XIFAXAN®

Bausch Health Companies Inc. together with Salix Pharmaceuticals, Inc., its gastroenterology business, announced a lawsuit against Amneal Pharmaceuticals entities in the District of New Jersey. This legal action is in response to Amneal's attempt to market a generic version of XIFAXAN® (rifaximin) 550 mg tablets following a Paragraph IV Certification. Amneal claims patents for XIFAXAN® are unenforceable, invalid, or not infringed by its ANDA product. This commencement of litigation prompts a 30-month stay on FDA approval for Amneal's ANDA under the Hatch-Waxman Act.

Bausch Health's CEO Thomas J. Appio expressed confidence in the company's XIFAXAN® intellectual property and committed to defending its gastrointestinal product line. Bausch Health has previously faced Paragraph IV Certifications for XIFAXAN® from multiple pharmaceuticals, resolving most through settlements while continuing to litigate against Norwich Pharmaceuticals.

XIFAXAN® is used for the treatment of adults with irritable bowel syndrome with diarrhea (IBS-D) and the reduction in risk of overt hepatic encephalopathy recurrence. Salix Pharmaceuticals remains a prominent player in specialty pharmaceuticals focused on gastrointestinal diseases.