Bausch Health says ruling prevents FDA approval of Norwich ANDA until 2029

Bausch Health and its gastroenterology business Salix Pharmaceuticals announced that the U.S. Court of Appeals for the Federal Circuit in the matter of “Salix Pharmaceuticals, LTD. et al v. Norwich Pharmaceuticals, Inc.” affirmed the May 17, 2023 decision of the U.S. District Court for the District of Delaware that had denied Norwich Pharmaceuticals’ motion for modification of the court’s final order preventing the U.S. Food and Drug Administration from approving its abbreviated new drug application, or ANDA, for Xifaxan 550 mg before Oct. 2, 2029. The Court of Appeals also affirmed the August 10, 2022 decision of the District Court that invalidated certain U.S. Patents protecting the composition and use of Xifaxan for treating IBS-D. As a result of the Federal Circuit’s decision, Norwich’s abbreviated new drug application for Xifaxan 550 mg remains barred from approval by the U.S. Food and Drug Administration until Oct. 2, 2029, the company stated. “We are pleased that the Federal Circuit maintained the judgment preventing the approval of Norwich’s abbreviated new drug application for XIFAXAN (rifaximin) 550 mg by the U.S. Food and Drug Administration until October 2029. While we are disappointed that the Federal Circuit affirmed the invalidity of certain XIFAXAN IBS-D patents and disagree with this aspect of the Court’s decision, we will continue to vigorously defend our intellectual property. We remain committed to advocating for the safety of patients who have benefited from continued access to XIFAXAN, and we look forward to continuing to serve those patients,” said CEO Thomas Appio.