Semaglutide (China Resources Double-Crane)

Novo Nordisk scored a major win in its wide-ranging legal fight to keep compounders from making copies of its obesity drug semaglutide. A federal district court in Texas on Thursday denied a request for a preliminary injunction from the Outsourcing Facilities Association, a trade group that’s seeking to put semaglutide back on the FDA’s official shortage list so that its members can lawfully compound the drug. Semaglutide is sold by Novo Nordisk as Ozempic and Wegovy. The latest decision, which was filed under seal, deals a second blow for compounding pharmacies. A similar ruling issued last month by the same court also denied a preliminary injunction over tirzepatide, sold by Eli Lilly as Zepbound and Mounjaro. Typically, mixing up copies of a brand-name drug, or compounding, is allowed only when there’s a shortage. The ruling means that large compounding facilities have until May 22 to stop making copies of semaglutide, and smaller compounding facilities must stop immediately or risk FDA enforcement action. The FDA didn’t immediately respond to a request for comment on whether it would take enforcement action. “With the end of the shortage of Wegovy and Ozempic, no patient should have to be exposed to unsafe, inauthentic ‘semaglutide’ drugs,” Steve Benz, Novo Nordisk’s corporate vice president, legal and US general counsel, said in a statement on Friday. “Patient safety remains a top priority for Novo Nordisk and the extensive nationwide legal actions we have taken to protect Americans from the health risks posed by illegitimate ‘semaglutide’ drugs are working.” Novo Nordisk said it’s filed 111 lawsuits to date in federal courts across 32 states against entities marketing compounded semaglutide. Med spas and telehealth companies such as Hims and Ro have jumped on the opportunity to market alternate versions of the popular GLP-1 drugs, but the FDA and drugmakers have warned that the compounded products are not tested or approved for safety and efficacy. The Outsourcing Facilities Association sued the FDA in February after the agency announced that the shortage of semaglutide was over. The trade group alleged that the FDA provided no opportunity for public comment and that it “arbitrarily disregarded the weighty evidence that pharmacies and patients across the nation lack access to semaglutide products.” The trade group is “deeply disappointed” that the court “misapprehended or failed to take into consideration the clear and convincing evidence that demonstrates that the manufactured supply of semaglutide is not able to meet the enormous demand in the U.S.,” OFA chairman Lee Rosebush said in a statement. Rosebush said the group is in discussions with the FDA.