Bausch Health says US court ruling blocks Norwich's Xifaxan generic until 2029

18 May 2023
firstwordpharma.com
Drug ApprovalPatent InfringementPatent ExpirationBiosimilar
Shares in Bausch Health jumped nearly 25% after the company said that a US court decision would prevent the launch of a generic version of Xifaxan (rifaximin) from Alvogen's Norwich Pharmaceuticals unit until 2029. Chief executive Thomas Appio called the ruling "important," adding "it is our long- standing position that the Xifaxan patent claims are valid and infringed."
Bausch sued Norwich in 2020 over its intention to start selling a Xifaxan generic before the drug's patents expire. The US District Court for the District of Delaware found last year that patents covering the composition and use of Xifaxan in irritable bowel syndrome with diarrhoea (IBS-D) are invalid, while those covering the drug's use for reducing the risk of hepatic encephalopathy (HE) recurrence are valid.
The latest decision relates to an attempt by Norwich to modify the court's final judgement, with the company seeking to remove the HE indication from its application and keep only use in IBS-D. However, the District Court of Delaware denied this move, with Bausch indicating that it prevents Norwich from launching its Xifaxan generic before October 2, 2029. The original split decision from 2022 is also currently being appealed by Bausch to the US Court of Appeals for the Federal Circuit.
Norwich's application at the centre of the legal case relates to the 550mg dose of Xifaxan, which is indicated for IBS-D and HE, while a filing for the 200mg dose of the drug was granted tentative FDA approval last year. The lower dose of Xifaxan is indicated for travellers' diarrhoea, something Bausch has said accounts for
The Salix segment generated revenue of $496 million in the first quarter of the year, with sales of Xifaxan growing 7%. Bausch previously entered into settlement agreements to delay generic entries of the product from Teva, Sun Pharmaceuticals and Novartis' Sandoz unit until 2028.
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