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A federal judge in Texas handed Novo Nordisk (NVO+2.41%) a big win late Thursday in its battle against cheaper versions of its blockbuster drugs Ozempic and Wegovy, rejecting a bid by compounding pharmacies to keep making the drugs while a legal challenge moves forward.
In a sealed order U.S. Judge Mark Pittman denied a request for preliminary injunction a trade group representing compounding pharmacies that would have prevented the Food and Drug Administration from taking action against its members for making knock-off versions using semaglutide, the active ingredient in the weight loss drugs.
Small-scale compounders must now immediately stop making their versions of Ozempic and Wegovy. Larger, federally licensed compounders have until May 22 to keep producing the copycats.
The popular drugs had been in short supply for some two years, which led the FDA to declare a shortage, thus allowing pharmacists to legally make compounded versions of the patented medications. Many telehealth companies also jumped into the market with compounded drugs. However, in February the FDA determined that the semaglutide shortage was over, leading to the lawsuit by Outsourcing Facilities Association.
“We are pleased the court has rejected the compounders’ attempts to undermine FDA’s data-based decision that the shortage of Wegovy® and Ozempic® is resolved,” said Steve Benz, Corporate Vice President, Legal and U.S. General Counsel, Novo Nordisk in an statement. He said that the company will continue driving legal actions forward “and escalate our efforts as necessary, while closely engaging with regulators and law enforcement.”
Compounding pharmacies make drugs tailored to individual prescriptions for a specific patient and are largely regulated by states rather than the FDA.
Eli Lilly (LLY+3.00%) has also taken aggressive legal action against compounding pharmacies, and on Wednesday filed lawsuits against four telehealth companies that offer cheaper versions of its weight loss drugs Mounjaro and Zepbound.