Bausch Health resolves IBS patent litigation
Canada-based Bausch Health has agreed to settle its dispute with generic maker Sandoz over the latter’s attempt to release a generic version of antibiotic Xifaxan (Rifaximin).
Under the terms of the agreement, announced yesterday, May 6, Sandoz has been granted a non-exclusive licence to market a royalty-free generic version of the antibiotic from January 1, 2028, if it receives approval from the Food and Drug Administration (FDA).
Xifaxan is used to treat irritable bowel syndrome as well as lower the risk of overt hepatic encephalopathy in adults.
In late 2019, Bausch, its gastroenterology division Salix Pharmaceuticals and Salix's licensor Alfasigma accused Sandoz of infringing 14 patents, after Sandoz filed an abbreviated new drug application (ANDA) for a generic 550mg Xifaxan product.
According to yesterday’s release: “Sandoz acknowledges the validity of the licensed patents. Final patent expiry on Xifaxan 550 mg tablets is October 2029.”
The Xifaxan litigation between the parties will be dismissed.
“Bausch Health and AlfaSigma remain confident in the strength of the Xifaxan patents, and they will continue to vigorously defend their IP,” added the release.
This isn’t the first time that Bausch has secured a settlement in Xifaxan-related litigation.
In September 2018, Bausch and Actavis reached a settlement, with Actavis receiving a non-exclusive licence effective January 1, 2028.
Under that agreement, if Actavis markets an authorised generic, the volume of the drug will be subject to manufacturing and supply limits until the final patent expiry and Bausch Health will receive a share of the profits.
