Bausch Health Announces Resolution Of XIFAXAN® Intellectual Property Litigation
Published: Sep 12, 2018
BRIDGEWATER, N.J., /PRNewswire/ -- Bausch Health Companies Inc. (NYSE/TSX: BHC) ("Bausch Health" or the "Company") along with its wholly owned subsidiary, Salix Pharmaceuticals,"Salix"), 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 licensors Cedars-Sinai Medical Center and Alfasigma SpA (collectively the "Salix Parties"), have agreed to resolve the outstanding intellectual property litigation with Actavis Laboratories FL, Inc. ("Actavis"), regarding XIFAXAN® (rifaximin) 550 mg tablets. Under the terms of the agreement, the Salix Parties will grant Actavis a non-exclusive license effective Jan. 1, 20281 to the Salix Parties' intellectual property relating to XIFAXAN 550 mg tablets in the United States.
Bausch Health will not make any financial payments or other transfers of value as part of the agreement. Actavis acknowledges the validity of the licensed patents. Final patent expiry on XIFAXAN 550 mg tablets is late 2029.
"This agreement reflects the strong intellectual property rights protecting XIFAXAN, which is important for our company, and more importantly, the patients we serve," said Joseph C. Papa, chairman and CEO, Bausch Health. "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."
Under the terms of the agreement, beginning Jan. 1, 20281, Actavis will have the option to: (1) market a royalty-free generic version of XIFAXAN 550 mg tablets, should it receive approval from the U.S. Food and Drug Administration on its Abbreviated New Drug Application, or (2) to market an authorized generic version of XIFAXAN 550 mg tablets with drug supply being provided by Salix. In the case an authorized generic is marketed, the volume of the authorized generic will be subject to manufacturing and supply quantities until final patent expiry, and Bausch Health will receive an undisclosed share of the economics from Actavis on its sales of an authorized generic.
The parties have agreed to dismiss all litigation related to XIFAXAN, and all intellectual property protecting XIFAXAN will remain intact and enforceable. The Company remains confident in the strength of the XIFAXAN patents, and will continue to vigorously defend its intellectual property.
"Alfasigma strongly protects its intellectual property rights regarding XIFAXAN, and we are pleased to have successfully resolved this matter in favor of patients, our company and partners," said Pier Vincenzo Colli, CEO, Alfasigma.
About Bausch Health
The XIFAXAN 550 mg product and the XIFAXAN trademark are licensed by Alfasigma SpA. to Salix Pharmaceuticals or its affiliates.
1Actavis will be able to begin marketing the medicine earlier if another generic rifaximin product is granted approval and starts selling or distributing such generic rifaximin product before Jan. 1, 2028.
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SOURCE Bausch Health Companies Inc.
Company Codes: NYSE:BHC, Toronto:BHC