Bausch targets Sandoz over IBS generic

Canadian pharmaceutical company Bausch Health is suing Sandoz for patent infringement over its notice of intent to release a generic version of Xifaxan (rifaximin), Bausch’s irritable bowel syndrome (IBS) drug.

According to the complaint, filed at the US District Court for the District of New Jersey on Monday, September 30, an abbreviated new drug application (ANDA) filed by Sandoz for a generic 550mg Xifaxan product infringes 14 patents.

Bausch’s Irish subsidiary and its gastroenterology division Salix Pharmaceuticals are listed as plaintiffs in the case, along with Italian company Alfasigma which licenses a number of the patents to Salix.

Sandoz, a subsidiary of Novartis, filed the ANDA (number 213713) with the US Food and Drug Administration last month.

Xifaxan is used to treat IBS as well as lower the risk of overt hepatic encephalopathy in adults.

It is not the first time the drug has been the subject of litigation.

In September 2018, Bausch and Actavis reached a settlement in a dispute over a generic version.

The agreement will grant Actavis a non-exclusive licence effective January 1, 2028, to Salix’s IP relating to 550mg Xixafan tablets in the US.

In August this year, Bausch settled a patent suit with Teva. In a similar deal to the one agreed with Actavis, Teva will obtain a licence to Apriso (mesalazine), a drug used to treat ulcerative colitis and Crohn's disease.

The Apriso licence will take effect October 1, 2028.

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