Market Exclusivity Case Study: XIFAXAN (rifaximin)

Bausch Health Companies Inc. along with its wholly owned subsidiary, Salix Pharmaceuticals, which is one of the largest specialty pharmaceutical companies in the world committed to the prevention and treatment of gastrointestinal diseases, together with Salix’s licensor Alfasigma SpA, have agreed to resolve the outstanding intellectual property litigation with Sandoz Inc., regarding XIFAXAN^® (rifaximin) 550 mg tablets. The Salix Parties will grant Sandoz a non-exclusive license effective Jan. 1, 2028 to its intellectual property relating to XIFAXAN 550 mg tablets in the United States.

Sandoz acknowledges the validity of the licensed patents. Final patent expiry on XIFAXAN 550 mg tablets is October 2029.

In October 2019, the Bausch Health Companies Inc. has filed a lawsuit against Sandoz Inc., a Novartis division, alleging patent infringement of 14 patents by Sandoz’s filing of its Abbreviated New Drug Application (ANDA) for XIFAXAN® (rifaximin) 550 mg tablets.

Under the terms of the agreement, beginning Jan. 1, 2028 (or earlier under certain circumstances), Sandoz will have the right to market a royalty-free generic version of XIFAXAN 550 mg tablets, should it receive approval from the U.S. Food and Drug Administration (FDA) on its Abbreviated New Drug Application.

Litigation between the parties related to XIFAXAN will be dismissed, and all intellectual Property protecting XIFAXAN remains intact. Bausch Health and AlfaSigma remain confident in the strength of the XIFAXAN patents, and they will continue to vigorously defend their intellectual property. XIFAXAN is protected by 23 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.

In September 2018, Bausch Health agreed to resolve earlier outstanding intellectual property litigation with Actavis Laboratories FL, Inc. (“Actavis”), regarding XIFAXAN 550 mg tablets. Under the terms of the agreement, the Salix Parties will grant Actavis a non-exclusive license effective Jan. 1, 2028² to the Salix Parties’ intellectual property relating to XIFAXAN 550 mg tablets in the United States.