Tashatuvango/iStock via Getty Images Bausch Health ( NYSE: BHC ) said it has filed a patent infringement suit against Norwich Pharmaceuticals in response to Norwich's filing of an application with the FDA to put out a generic version of Bausch’s Xifaxan 550 mg tablets. Bausch noted that a US District Court in 2022 ruled against Norwich’s first application to market a generic version of the drug. The ruling was later confirmed on appeal.
Bausch added it has since received additional patents for the product and intends to “vigorously defend” its intellectual property, according to a statement. Xifaxin 550 mg tablets are approved by the FDA for the reduction in risk of overt hepatic encephalopathy recurrence and the treatment of irritable bowel syndrome with diarrhea, or IBS-D, in adults. Bausch said in mid-May that it had been notified that Norwich had applied to market a generic version of Xifaxin 550 mg for IBS-D.
Bausch added that it had 45 days from receipt of the notice to file a patent infringement suit against Norwich, which would preclude the FDA from approving Norwich’s application for up to 30 months unless a district court ruled in Norwich’s favor first. More on Bausch Health Companies Why Bausch Health Stock Plunged After Posting First Quarter 2024 Results Bausch Health Companies (BHC) Q1 2024 Earnings Call Transcript Bausch Health Companies Inc. 2024 Q1 - Results - Earnings Call Presentation Bausch issues update on Xifaxan patent dispute with Norwich Ba.
