Bausch Health files patent lawsuit against Amneal Pharmaceuticals

Bausch Health Companies (BHC) along with its gastroenterology business, Salix Pharmaceuticals, announced that it filed a lawsuit in the United States District Court for the District of New Jersey against Amneal Pharmaceuticals (AMRX) of New York, Amneal EU, Limited, Amneal Pharmaceuticals, Amneal Pharmaceuticals Private Limited, and Amneal Pharmaceuticals. This lawsuit follows receipt of a Notice of Paragraph IV Certification stating that Amneal submitted an Abbreviated New Drug Application to the U.S. FDA seeking approval to market a generic version of XIFAXAN 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.