LAVAL, QC / ACCESSWIRE / April 11, 2024 / Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC), and its gastroenterology business Salix Pharmaceuticals, today 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, Inc.'s motion for modification of the court's final order preventing the U.S. Food and Drug Administration (FDA) from approving its abbreviated new drug application (ANDA) for XIFAXAN (rifaximin) 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 (rifaximin) 550 mg remains barred from approval by the U.S. Food and Drug Administration until Oct. 2, 2029.
LAVAL, QC / ACCESSWIRE / April 5, 2024 / Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC) along with its gastroenterology business, Salix Pharmaceuticals, Inc., announced that it filed a lawsuit today in the United States District Court for the District of New Jersey against Amneal Pharmaceuticals of New York, LLC, Amneal EU, Limited, Amneal Pharmaceuticals, LLC, Amneal Pharmaceuticals Private Limited, and Amneal Pharmaceuticals, Inc. This lawsuit follows receipt of a Notice of Paragraph IV Certification stating that Amneal submitted an Abbreviated New Drug Application (ANDA) to the U.S. Food and Drug Administration (FDA) seeking approval to market a generic version of XIFAXAN® (rifaximin) 550 mg tablets. Amneal asserts that certain patents listed in the FDA's Orange Book for XIFAXAN® are unenforceable, invalid, and/or not infringed by Amneal's ANDA product. This action formally initiates the litigation process under the Hatch-Waxman Act and triggers a 30-month stay of any potential FDA approval for Amneal's ANDA.
Bausch Health’s gastroenterology unit Salix Pharmaceuticals has chalked up a win in its long-running fight to fend off a generic to its irritable bowel syndrome diarrhea (IBD-D) med Xifaxan.
LAVAL, QC / ACCESSWIRE / June 19, 2023 / Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC) and its gastroenterology business, Salix Pharmaceuticals, today announced its presence at the European Association for the Study of the Liver (EASL) Congress 2023. XIFAXAN® (rifaximin) data was selected for inclusion in the Cirrhosis and its complication's session. EASL Congress 2023 will be held virtually and in-person in Vienna, Austria, from June 21-24, 2023.
Norwich's Generic Rifaximin Receives Approval in the U.S.
LAVAL, Quebec, May 17, 2023 – Bausch Health Companies Inc. (NYSE/TSX: BHC), and its gastroenterology business Salix Pharmaceuticals, today announced that the U.S. 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 U.S. Food and Drug Administration (FDA) from approving Norwich’s abbreviated new drug application (ANDA) for XIFAXAN® (rifaximin) 550 mg before Oct. 2, 2029. As a result of this decision, Norwich’s ANDA cannot be approved until Oct. 2, 2029.
Norwich's Generic Rifaximin Receives Approval in the U.S.