Bausch Health files patent lawsuit against Amneal Pharma

6 April 2024

Canada-based Bausch Health (NYSE/TSX: BHC) saw its shares rise 3.6% to $10.41 after it revealed that, along with its gastroenterology unt Salix Pharmaceuticals, it has filed a lawsuit today in the US District Court for the District of New Jersey against Amneal Pharmaceuticals (Nasdaq: AMRX) and its subsidiaries.

This lawsuit follows receipt of a Notice of Paragraph IV Certification stating that Amneal submitted an Abbreviated New Drug Application (ANDA) to the US Food and Drug Administration (FDA) seeking approval to market a generic version of the irritable bowel syndrome drug Xifaxan (rifaximin) 550mg 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.

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