Bausch Health provides update following oral order in Xifaxan patent litigation
Bausch Health Companies Inc. and its gastroenterology business Salix Pharmaceuticals, announced the U.S. District Court of Delaware issued an Oral Order in the matter of Salix Pharmaceuticals, Ltd. et al v.
Norwich Pharmaceuticals, Inc. regarding the infringement and validity of certain U.S. Patents protecting the composition and use of Xifaxan (rifaximin) 550 mg tablets for the treatment of irritable bowel syndrome with diarrhea (IBS-D) and reduction in risk of overt hepatic encephalopathy (HE) recurrence.
The Oral Order indicates that the Court will find certain U.S. Patents protecting the use of Xifaxan (rifaximin) 550 mg tablets for the reduction in risk of HE recurrence valid and infringed and U.S. Patents protecting the composition, and use of Xifaxan for treating IBS-D, invalid. While the Court has not yet entered any final judgement, absent Norwich's removal of the HE indication and data from their Abbreviated New Drug Application (ANDA), it is expected that the Court will enjoin Norwich's pending ANDA until expiration of the Xifaxan HE Patents in 2029. The Company intends to vigorously oppose any attempt by Norwich to remove the HE safety data from its ANDA in an effort to avoid the Xifaxan HE Patents.
The FDA has stated that they plan to make a major revision to the rifaximin product specific guidance to add an in vivo bioequivalency study. Until an approval of a revised ANDA is granted by the FDA and the expected injunction modified by the Court, Norwich is not permitted to launch a generic equivalent of Xifaxan. When the Court enters a final order, Bausch Health will consider all available options to vigorously defend the intellectual property protecting Xifaxan and will appeal the Court's decision to the U.S. Court of Appeals for the Federal Circuit.
"We are disappointed with today's development. We strongly disagree with any conclusion that our patents are not valid and intend to file an appeal to any such order," Thomas J. Appio, CEO, Bausch Health, said. "As a leader in gastrointestinal health, protecting our intellectual property is essential to our ability to continue to develop innovative therapies. We intend to vigorously pursue all available options to challenge any final ruling, while also continuing to drive growth and innovation for our Xifaxan franchise."
Bausch Health has previously entered into settlement agreements with Teva, Sun Pharmaceuticals, and Sandoz to permit a generic rifaximin product entry in 2028 or upon an earlier approval and launch of a generic rifaximin product. Until, and if, Norwich secures FDA approval for its generic rifaximin product and subsequently launches a generic rifaximin product, Teva, Sun Pharmaceuticals, and Sandoz will not be permitted to launch a generic version of Xifaxan tablets before 2028.
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