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23 September 2020AmericasSarah Morgan

Bausch Health settles with Sun Pharma

Canada-based Bausch Health has dropped its litigation against Indian generic maker Sun Pharma as part of a settlement agreement.

Bausch Health announced the settlement—which resolves all litigation concerning Xifaxan (rifaximin), an antibiotic used to treat traveller's diarrhoea—yesterday, September 22.

As part of the agreement, Bausch Health’s gastroenterology business Salix Pharmaceuticals will grant Sun Pharma a non-exclusive licence to the Xifaxan IP in the US, effective January 1, 2028.

Sun Pharma will have the right to market royalty-free generic versions of Xifaxan 200mg and  550mg tablets, if it receives approval from the US Food and Drug Administration (FDA) on its Abbreviated New Drug Application.

Bausch Health had filed suit against Sun Pharma in April 2019, after receiving notice that the India company planned to produce a generic version of the antibiotic.

Joseph Papa, chairman and CEO of Bausch Health, said: “Resolving these matters with Sun is another testament to the strength of the Xifaxan IP.

“We will continue to defend our IP protecting Xifaxan, and we will continue to invest in the research and development of new indications and formulations for rifaximin that can potentially benefit more patients."

Final patent expiry on Xifaxan 200mg and 550mg tablets are July and October 2029, respectively.

In May this year, Bausch Health resolved its Xifaxan litigation with Sandoz. As part of the agreement, Sandoz was granted a non-exclusive licence from January 1, 2028, subject to the FDA’s approval of its generic.

Actavis was also granted a non-exclusive licence from the same date, when it settled litigation with Bausch Health in September 2018.

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