Containers of Ozempic and Wegovy seen at Children’s Hospital in Aurora, CO, Nov. 18, 2024.
Kevin Mohatt | The Washington Post | Getty Images
A federal judge in Texas has rejected a bid by compounding pharmacies to allow them to continue making copies of Novo Nordisk’s blockbuster drugs Ozempic and Wegovy, upholding the U.S. Food and Drug Administration’s decision to remove the drugs’ active ingredient from the shortage list.
In a decision made public late on Tuesday, U.S. District Judge Mark Pittman in Fort Worth, Texas said that the FDA had appropriately weighed information about the supply and demand for semaglutide and properly removed it from the shortage list.
A spokesperson for The Outsourcing Facilities Association, the lead plaintiff in the case, did not immediately respond to a request for comment. Neither did representatives for the FDA.
Pittman had denied the pharmacies’ bid for an injunction in April, blocking them from making copies of the drugs while the litigation was pending.
The ruling is a blow to compounding pharmacies that had been allowed to produce hundreds of thousands of doses of copies of obesity drugs while the FDA said there was a shortage of them and could dash patients’ hopes of regaining access to cheaper copies of the popular therapies.
Pittman rejected separate challenge in May
In its lawsuit, filed in February 2025, the association alleged that the FDA had acted recklessly in removing semaglutide from the shortage list while there was evidence that the drugs were still in short supply.
In part, it argued that the agency had failed to consider statements then Novo Nordisk CEO Lars Fruergaard Jorgensen made about limited access to the drugs in a November 2024 interview with Reuters. Fruergaard left the Danish company last month over concerns the company was losing its market advantage in the competitive weight-loss drug market.
Pittman said the record shows the FDA was aware of the statements and had confronted Novo with them when it made its decision.
Compounders copy brand-name medicines that are in short supply by combining, mixing or altering drug ingredients to meet demand.
The regulator gave larger so-called outsourcing facilities, which make compounded drugs in bulk and are regulated by the agency, until May 22 to stop making the drugs, according to its website. Smaller compounding pharmacies, which make drugs to fill prescriptions for individual patients and are primarily overseen by U.S. states, were required to stop making copies of semaglutide in April.
Pittman rejected a separate challenge in May brought by the same groups over the FDA’s removal of Eli Lilly’s weight loss and diabetes drugs Zepbound and Mounjaro from the shortage list. The Outsourcing Facilities Association has appealed that ruling.
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