Bausch Health Co. Inc. (BHC) to Appeal XIFAXAN Patent Decision

August 10, 2022 6:09 PM EDT

Bausch Health Companies Inc. (NYSE: BHC), and its gastroenterology business Salix Pharmaceuticals, today announced that, consistent with the company's July 28, 2022, press release, the U.S. District Court of Delaware has issued a decision in the matter of Salix Pharmaceuticals, Ltd. et al v. Norwich Pharmaceuticals, Inc. finding certain XIFAXAN® (rifaximin) 550 mg HE patents valid and infringed and certain XIFAXAN composition and IBS-D patents invalid. As previously stated, the Company will appeal this decision to the U.S. Court of Appeals for the Federal Circuit and it expects an appeal decision to issue within 12 to 18 months.

To date, Norwich has not received tentative or final approval of its ANDA from the FDA. Unless and until FDA approves a revised Norwich ANDA that omits the XIFAXAN HE indication, and any injunction issued by the Court is modified, Norwich is not permitted to launch a generic equivalent of XIFAXIN.



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