Bausch Health 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 remains confident in its XIFAXAN intellectual property and we will continue to defend our XIFAXAN franchise for the benefit of patients," Thomas J. Appio, CEO, Bausch Health said. "As a leader in gastrointestinal health, protecting our intellectual property is essential to our ability to continue to develop innovative therapies."
Bausch Health has previously received Paragraph IV Certifications for XIFAXAN (rifaximin) 550 mg tablets from Teva Pharmaceuticals, Sandoz Inc., Sun Pharmaceuticals and Norwich Pharmaceuticals. The company has since settled the matters with Teva, Sandoz and Sun in September 2018, May 2020 and September 2020, respectively, while litigation with Norwich remains ongoing.
