Salix Pharmaceuticals, the gastroenterology division of Bausch Health, has successfully defended its irritable bowel syndrome diarrhea medication, Xifaxan, against a generic competitor. A US federal court in the District of Columbia recently denied Norwich Pharmaceuticals’ effort to compel the FDA to approve its generic alternative.
Earlier, a Delaware court ruled that Norwich’s generic infringed on three of Salix’s patents tied to the use of Xifaxan for hepatic encephalopathy, with the court prohibiting the generic’s launch until the patents expire in 2029. The court also found that some patents associated with the IBD-D indication were not valid.
In response, Norwich, part of Alvogen, eliminated the hepatic encephalopathy indication from its application and sought FDA approval for a “skinny label” that would only cover IBD-D. The FDA tentatively approved this generic but withheld final approval until 2029, effectively blocking its release until then.
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Norwich is “disappointed” in the ruling and is evaluating a potential appeal, Alvogen’s chief legal officer Andrea Sweet told Fierce Pharma in an emailed statement.
“We are confident that the Federal Circuit will uphold the invalidity of the IBS-D and polymorph patents, and also grant Norwich the relief required for FDA to approve Norwich’s application, with IBS-D as the sole indication, without further delay,”
– Andrea Sweet, chief legal officer
Bausch Health has welcomed the court’s decision. Meanwhile, Salix awaits the outcome of its appeal against the invalidation of some of its patents, a decision that’s expected in early 2024.
To date, Salix has arranged agreements with Actavis, Sandoz (a Novartis company), and Sun Pharma to delay their generic versions of Xifaxan until 2028. Xifaxan remains a pivotal product for Bausch Health and contributed to Salix’s 13% growth in the third quarter of this year.
