LAVAL, QC - Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC) and its subsidiary Salix Pharmaceuticals announced a legal victory in the ongoing patent litigation concerning their drug XIFAXAN (rifaximin) 550 mg. The U.S. Court of Appeals for the Federal Circuit upheld a previous court decision that prevents Norwich Pharmaceuticals, Inc. from obtaining approval for a generic version of the drug until October 2, 2029.
The appellate court affirmed the U.S. District Court for the District of Delaware's May 17, 2023, ruling that denied Norwich Pharmaceuticals' motion to modify the court's final order. This decision bars the U.S. Food and Drug Administration (FDA) from approving Norwich's abbreviated new drug application (ANDA) for the medication. Additionally, the Federal Circuit concurred with the lower court's August 10, 2022, decision that invalidated certain U.S. patents related to the composition and use of XIFAXAN for treating irritable bowel syndrome with diarrhea (IBS-D).
Thomas J. Appio, CEO of Bausch Health, expressed satisfaction with the Federal Circuit's decision to maintain the judgment, emphasizing the company's commitment to defending its intellectual property. Despite the invalidation of certain patents, Appio stated that Bausch Health would continue to advocate for patient safety and access to XIFAXAN.
XIFAXAN 550 mg tablets are prescribed for reducing the risk of overt hepatic encephalopathy (HE) recurrence and treating IBS-D in adults. Salix Pharmaceuticals, the gastroenterology business of Bausch Health, has been marketing products for gastrointestinal diseases for over three decades and is one of the largest specialty pharmaceutical companies in the world.
The company's legal stance and the outcome of the appeal are based on information provided in a press release statement. Bausch Health has made it clear that it will continue to take measures to protect its intellectual property rights related to XIFAXAN and other products in its portfolio. The recent court decision plays a significant role in the company's strategy to maintain exclusivity over its product until the specified date in 2029.
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