Alvogen's bid to force FDA to approve generic to Bausch's Xifaxan shot down by federal court

03 Nov 2023
www.fiercepharma.com
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Alvogen's bid to force FDA to approve generic to Bausch's Xifaxan shot down by federal court
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Source: FiercePharma
The companies have been duking it out in court over the proposed generic since 2020.
Bausch Health’s gastroenterology unit Salix Pharmaceuticals has chalked up a win in its long-running fight to fend off a generic to its irritable bowel syndrome diarrhea (IBD-D) med Xifaxan.
This week, the U.S. District Court for the District of Columbia slapped down Norwich Pharmaceuticals’ bid to force the FDA to approve its proposed generic version of the medicine.
Previously, a Delaware court found that Norwich’s generic would step on three Salix patents that relate to Xifaxan’s hepatic encephalopathy (HE) indication, ruling that the copycat can’t launch until those patients expire in 2029. The court also ruled that certain Xifaxan patents in the IBD-D use were invalid.
Norwich, a subsidiary of Alvogen, then scrapped the HE use from its generic’s label and pressed the FDA to grant its drug a skinny label to treat IBD-D.
The FDA tentatively approved the generic but passed on granting a final approval until 2029, meaning the drug cannot launch in the interim.
Norwich challenged the FDA’s move, but now the D.C. court has ruled in the FDA and Salix's favor.
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,” Sweet added.
Meanwhile, Bausch is “pleased with this outcome,” the company said in a statement. Salix is still waiting on a decision from its appeal of the court’s move to scratch some of its patents, which is expected to come during the first quarter of 2024.
Salix has so far struck deals with Actavis, Novartis’ Sandoz and Sun Pharma to keep their generics off the market until 2028. Xifaxan has long been a core med for Bausch and drove Salix’s 13% growth rate over this year’s third quarter.
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