Bausch Health, Alfasigma resolve Xifaxan litigation with Sun Pharma

Bausch Health, its Salix business unit, and Salix’s licensor Alfasigma, have agreed to resolve outstanding intellectual property disputes with Sun Pharmaceuticals regarding Xifaxan (rifaximin) 200-mg and 550-mg tablets.

The Salix Parties will grant Sun a non-exclusive license effective Jan. 1, 2028 to its intellectual property relating to Xifaxan 200-mg and 550-mg tablets in the United States.

In April 2019, Bausch Health filed a lawsuit against Sun following receipt of a Notice of Paragraph IV Certification relating to Xifaxan 200-mg tablets. Additionally, Bausch Health received a Notice of Paragraph IV Certification from Sun relating to Xifaxan 550-mg tablets on Aug. 10. 

"Resolving these matters with Sun is another testament to the strength of the Xifaxin intellectual property," said Joseph Papa, Bausch Health chairman and CEO. "We will continue to defend our intellectual property 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."

"Alfasigma is satisfied with the resolution," said Pier Vincenzo Colli, Alfasigma CEO. "In the interest of patients and customers, our company is committed to using any efforts to protect its intellectual property covering Xifaxan."

Sun acknowledges the validity of the licensed patents with respect to the two Xifaxan products. Final patent expiry on Xifaxan 200-mg and 550-mg tablets are July and October 2029, respectively.

Under the terms of the agreement, beginning Jan. 1, 2028 (or earlier under certain circumstances), Sun will have the right to market royalty-free generic versions of Xifaxan 200 mg and  550 mg tablets, should it receive approval from the Food and Drug Administration on its ANDA.

Litigation between the parties related to Xifaxan will be dismissed, and all intellectual Property protecting Xifaxan remains intact.

Bausch Health and Alfasigma said they remain confident in the strength of the Xifaxan patents, and they will continue to vigorously defend their intellectual property.

Xifaxan 200-mg and 550-mg tablets are collectively protected by 26 patents covering the composition of matter and the use of Xifaxan listed in the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations, or the Orange Book.

Bausch Health agreed to resolve outstanding intellectual property litigation with Actavis and Sandoz regarding Xifaxan 550-mg tablets in September 2018 and in May 2020, respectively. Under the terms of the agreements, the Salix Parties will grant Actavis and Sandoz non-exclusive licenses effective Jan. 1, 2028 to the Salix Parties' intellectual property relating to Xifaxan 550 mg tablets in the United States