04:40 PM EDT, 05/14/2024 (MT Newswires) -- Bausch Health Companies Inc. ( BHC ) and its gastroenterology business Salix Pharmaceuticals, after trade Tuesday announced certain updates related to its litigation with Norwich Pharmaceuticals, Inc.
With respect to the April 11, 2024, decision of the US Court of Appeals for the Federal Circuit, both Bausch Health ( BHC ) and Norwich have filed petitions for panel rehearing or rehearing en banc, a statement said. A decision on whether a rehearing will be granted is expected within the next three months, it added.
Tuesday's statement noted the company has also received notice of a new Paragraph IV certification, dated May 10, 2024, from Norwich advising that it has submitted to the U.S. Food and Drug Administration (FDA) an amendment to an Abbreviated New Drug Application (ANDA) requesting approval to market a generic version of XIFAXAN (rifaximin) 550 mg tablets for the treatment of irritable bowel syndrome with diarrhea in adults.
Bausch Health ( BHC ) said it is reviewing the Notice and has 45 days from receipt of the Notice to commence a patent infringement lawsuit against Norwich. Bausch Health ( BHC ) added it understands that such a lawsuit would automatically preclude the FDA from approving Norwich's ANDA for up to 30 months or until the issuance of a decision by the district court in this matter that is adverse to Bausch Health ( BHC ), whichever occurs first.
Bausch Health ( BHC ) said it intends to vigorously enforce its intellectual property rights relating to XIFAXAN.