Federal Court Upholds Ruling Against Norwich’s ANDA for XIFAXAN Until 2029

Bausch Health Companies Inc., alongside its gastroenterology arm Salix Pharmaceuticals, announced that the U.S. Court of Appeals for the Federal Circuit has affirmed earlier court decisions that prevent the FDA approval of Norwich Pharmaceuticals, Inc.’s abbreviated new drug application (ANDA) for XIFAXAN (rifaximin) 550 mg until October 2, 2029. This decision follows the affirmation of a May 2023 U.S. District Court ruling and an August 2022 decision that invalidated certain patents of XIFAXAN but concurrently barred Norwich’s ANDA approval.

Thomas J. Appio, CEO of Bausch Health, expressed satisfaction with the maintenance of the judgment against Norwich’s application, emphasizing the company’s commitment to defending its intellectual property and ensuring patient safety for users of XIFAXAN. Despite the invalidation of some patents related to the drug’s IBS-D treatment indications, Bausch Health intends to continue its vigorous defense of its IP rights while supporting the continued access to the drug for patients.