Novo Nordisk legal win bars many compounded Wegovy, Ozempic drugs

Novo Nordisk scored an enormous legal victory that largely restricts compounding pharmacies from marketing or selling cheaper, unapproved versions of the drugmaker’s blockbuster weight reduction drug Wegovy and diabetes treatment Ozempic. 

A federal judge in Texas late Thursday rejected a bid by compounding pharmacies to maintain making copies of Ozempic and Wegovy while a legal challenge over the shortage of those drugs unfolds. That got here in response to a February lawsuit from a compounding trade group against the Food and Drug Administration’s determination that the energetic ingredient in those drugs, semaglutide, isn’t any longer in shortage within the U.S.

Patients flocked to the cheaper copycats when Ozempic and Wegovy were briefly supply during the last two years because of skyrocketing demand, or in the event that they did not have insurance coverage for the costly treatments. 

During FDA-declared shortages, pharmacists can legally make compounded versions of brand-name medications. Many telehealth corporations, resembling Hims & Hers, also offered those copycats. But drugmakers and a few health experts have pushed back against the practice since the FDA doesn’t approve compounded drugs, that are essentially custom-made copies prescribed by a physician to fulfill a particular patient’s needs. 

“We’re pleased the court has rejected the compounders’ attempts to undermine FDA’s data-based decision that the shortage” of semaglutide is resolved, said Steve Benz, Novo Nordisk’s corporate vice chairman, legal and U.S. general counsel, in a press release. 

“Patient safety stays a top priority for Novo Nordisk and the extensive nationwide legal actions now we have taken to guard Americans from the health risks posed by illegitimate ‘semaglutide’ drugs are working,” he said, referring to the corporate’s greater than 100 lawsuits against compounding pharmacies and other entities across 32 states. 

On Thursday, U.S. District Judge Mark Pittman specifically denied the Outsourcing Facilities Association’s bid for a preliminary injunction that might have prevented the FDA from taking motion against its members for making copies of semaglutide. 

That call upholds the FDA’s previous determination that the semaglutide shortage within the U.S. is over and means the FDA can now immediately go after so-called 503A pharmacies which can be making compounded versions of semaglutide in accordance with individual prescriptions for a particular patient.

Those pharmacies are largely regulated by states moderately than the FDA.

The choice also means the FDA can start targeting federally regulated 503B pharmacies, which manufacture compounded drugs in bulk with or without prescriptions, after May 22. The agency’s actions can include product seizures and warning letters to pharmacies. 

The choice on Thursday follows one other win for Novo Nordisk. A special federal judge in Texas earlier this week ruled in favor of the drugmaker against a 503A pharmacy, MediOak Pharmacy, permanently prohibiting the business from marketing or selling compounded semaglutide.

Novo Nordisk and Eli Lilly have aggressively cracked down on compounding pharmacies during the last two years as they profit from the soaring popularity of their weight reduction and diabetes drugs.

Eli Lilly has undergone an analogous legal process with tirzepatide, the energetic ingredient in its weight reduction drug Zepbound and diabetes treatment Mounjaro. The FDA declared the U.S. shortage of tirzepatide over last 12 months, prompting the identical compounding trade group to sue the FDA over the drug. 

In March, a federal judge denied the compounding group’s request for a preliminary injunction on the FDA’s enforcement against its members for making copies of Mounjaro and Zepbound. The compounding group has appealed.