Norwich Bruised As Failed US Rifaximin Appeal Bars Approval Until 2029

Sandoz, Teva Among Settled ANDA Sponsors; Xifaxan Brand Worth $1.6bn Annually

 
• By Dean Rudge

Norwich Pharmaceuticals looks set for a five-year wait to launch its generic version of Bausch Health’s core Xifaxan, after the Federal Circuit shot down its appeal to a bar on US FDA approval. The generics manufacturer has previously sought to supercharge its approval by carving a patent-protected indication from the label.

2029
• Source: Shutterstock: SoniaDigital

Norwich Pharmaceuticals must continue to wait until October 2029 for final US approval of its proposed generic version of Bausch Health’s Xifaxan (rifaximin) 550mg tablets. The US Court of Appeals for the Federal Circuit has sided with a lower court’s order barring final approval until the expiration date of three US patents found to have been earlier infringed by the generics manufacturer.

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