US District Court upholds final judgment for Xifaxan

Shares of Canada-based Bausch Health Companies (TSX: BHC) were up 14.6% at $8.56 on Wednesday, after it said that a US district court stuck with an earlier judgment that prevented an application for a rival generic version of its Xifaxan (rifaximin) irritable bowel syndrome drug from getting US Food and Drug Administration (FDA) approval until 2029.

Bausch and its gastroenterology business Salix Pharmaceuticals, announced that the US District Court of Delaware in the matter of Salix Pharmaceuticals, LTD et al v Norwich Pharmaceuticals Inc, has denied Norwich Pharmaceuticals’ motion to modify the Court’s final judgment that prevents the FDA from approving Norwich’s abbreviated new drug application (ANDA) for Xifaxan 550 mg before October 2, 2029. As a result of this decision, Norwich’s ANDA cannot be approved until that date.

“This decision is important for patients who continue to depend on a proven and highly effective drug to treat gastro-intestinal disorders,” Thomas Appio, chief executive stated. “It is our long- standing position that the Xifaxan patent claims are valid and infringed by Norwich’s ANDA. We will continue to advocate for the safety of patients who have benefited from the continued access to XIFAXAN, and we look ahead to the appeal process,” he added.