Bausch Health files patent infringement lawsuit against Norwich Pharmaceuticals

Bausch Health and its gastroenterology business, Salix Pharmaceuticals, has filed a patent infringement lawsuit in the District Court for the District of New Jersey against Norwich Pharmaceuticals. This lawsuit was filed in connection with the Notice of Paragraph IV Certification dated May 10 received from Norwich advising that it has submitted to the FDA an amendment to an Abbreviated New Drug Application requesting approval to market a generic version of Xifaxan 550 mg tablets for the treatment of diarrhea-predominant irritable bowel syndrome. Bausch Health continues to defend challenges to its Xifaxan intellectual property. In the first Norwich lawsuit, the U.S. District Court for the District of Delaware issued a ruling in August 2022 that barred Norwich’s first ANDA for Xifaxan 550 mg from approval by the FDA until October 2029. On appeal, the ruling was confirmed. Since the District Court’s ruling, Bausch Health received additional patents related to Xifaxan 550 mg.