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.
Norwich Bruised As Failed US Rifaximin Appeal Bars Approval Until 2029
Sandoz, Teva Among Settled ANDA Sponsors; Xifaxan Brand Worth $1.6bn Annually
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.
More from Legal & IP
• By
A UK High Court justice came down on the side of Glenmark in AstraZeneca’s bid to enjoin the firm from launching a generic version of its Forxiga blockbuster before judgment is delivered in the firms’ patent-litigation clash.
• By
Teva should not be able to overturn European fines imposed over a historical “pay-for-delay” arrangement covering Cephalon’s Provigil (modafinil), an advocate general of the CJEU has recommended.
• By
In a precedential decision, the US Court of Appeals for the Federal Circuit has determined the meaning of the language “the patent” as it applies to patent-term extensions for reissued patents, in the context of Aurobindo’s bid to wipe out a reissued patent shielding Merck & Co’s Bridion (sugammadex) injectable.
• By
Novartis’ multi-front legal battle against MSN Laboratories over its Entresto blockbuster in the US has taken yet another twist, with a federal district court in New Jersey finding that a preliminary injunction was warranted against MSN’s product on the basis of infringement of Novartis’ trade dress.