Bausch Health settles generic dispute with Actavis

Canada-based Bausch Health has agreed to settle all IP litigation with Actavis over antibiotic drug Xifaxan (rifaximin).

Actavis, which is owned by generics maker Teva, has agreed to wait ten years before releasing a generic version of the antibiotic.

In an announcement made yesterday, September 12, Bausch Health said that it had granted Actavis a non-exclusive licence to the IP, effective January 1, 2028.

Xifaxan is used to treat traveller’s diarrhoea, irritable bowel syndrome, and hepatic encephalopathy, a syndrome observed in patients with cirrhosis.

Bausch Health will not make any financial payments or other value transfers as part of the agreement.

From 2028, Actavis will be able to either market a royalty-free generic version of Xifaxan, following approval of its Abbreviated New Drug Application (ANDA), or sell an authorised version with drug supply being provided by Salix (a Bausch Health subsidiary).

If Actavis markets an authorised generic, the volume of the drug will be subject to manufacturing and supply quantities until the final patent expiry (in late 2029) and Bausch Health will receive a share of the profits.

Salix sued Actavis in March 2016, accusing the generics maker of infringing 24 patents relating to Xifaxan, after Actavis alerted Salix that it had submitted an ANDA in February that year.

Joseph Papa, chairman and CEO of Bausch Health, said: “We have always believed in the durability of the Xifaxan franchise, and this agreement supports our continued investment in the research and development of new indications for Xifaxan to benefit patients.”

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