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Bausch Health (NYSE:BHC) said it has filed a patent infringement lawsuit against Norwich Pharmaceuticals in response to Norwich’s application to the FDA to launch a generic version of Bausch’s Xifaxan 550 mg tablets.
Bausch pointed out A U.S. District Court in 2022 rejected Norwich’s first bid to sell generic versions of the drug. The ruling was later confirmed on appeal. Bausch added that the company has obtained additional patents for the product and intends to “vigorously defend” its intellectual property rights, according to a statement.
Xifaxin 550 mg tablet is FDA-approved to reduce the risk of recurrence of overt hepatic encephalopathy and to treat irritable bowel syndrome with diarrhea (IBS-D) in adults.
Bausch said in mid-May that it had learned that Norwich had applied to market a generic version of Xifaxin 550 mg for the treatment of IBS-D. Bausch added that the company has 45 days from receipt of the notice to file a patent infringement lawsuit against Norwich, which would prevent the FDA from approving Norwich’s application for up to 30 months unless a district court first rules. A favorable ruling in Norwich.
