Bausch Health gets largely favorable US Court of Appeals ruling in Norwich case

Canada-based Bausch Health (NYSE/TSX: BHC), and its gastroenterology business Salix Pharmaceuticals, announced that the US Court of Appeals for the Federal Circuit announced a positive ruling on its patent dispute with Norwich Pharmaceuticals.

The Court affirmed the May 17, 2023 decision of the US District Court for the District of Delaware that had denied Norwich’s motion for modification of the court’s final order preventing the US Food and Drug Administration (FDA) from approving its abbreviated new drug application (ANDA) for Xifaxan (rifaximin) 550mg before Oct. 2, 2029.

Bausch Health noted that the Court of Appeals also affirmed the August 10, 2022 decision of the District Court that invalidated certain US Patents protecting the composition and use of Xifaxan for treating irritable bowel syndrome (IBS-D). As a result of the decision, Norwich’s ANDA for Xifaxan remains barred from approval by the US FDA until October 2, 2029.