The basics:

• U.S. judge denies injunction request from Outsourcing Facilities Association
• Pharmacies must immediately stop making compounded semaglutide products
• FDA ruled Wegovy and Ozempic shortages resolved, ending special compounding permissions

A federal court in Texas reportedly dismissed a bid by drug compounders to continue producing off-brand versions of Novo Nordisk‘s weight-loss drug Wegovy and diabetes treatment Ozempic while a lawsuit plays out.

In an April 24 sealed order, U.S. Judge Mark Pittman in Fort Worth denied a request for a preliminary injunction that would have prevented the U.S. Food and Drug Administration from taking action against companies for making copies using semaglutide, the active ingredient in Novo Nordisk’s blockbuster GLP-1 medications, Reuters reported.

The ruling stemmed from a lawsuit filed in February by the Outsourcing Facilities Association over the health regulator’s decision to remove semaglutide from its shortage list. An industry group, OFA represents compounding pharmacies.

With the injunction request denied, state-licensed pharmacies and physicians known as 503A compounders must stop making and distributing semaglutide products immediately. Outsourcing facilities, designated as 503B’s, have until May 22 to do the same.

How we got here

Under U.S. regulations, compounding pharmacies can make and sell large quantities of brand-name medicines only if they are in short supply.

After the FDA declared a semaglutide shortage in 2022, pharmacies, telehealth companies and other health care providers have been able to manufacture copycat versions of Novo Nordisk‘s GLP-1 therapies. Since then, interest in compounded treatments has skyrocketed. Consumers consider them a cheaper, and easier to access, alternative to the branded drugs.

When the FDA announced its decision in February to remove semaglutide from its shortage list, the OFA filed a lawsuit. The complaint claims that the federal agency is “dismissing evidence that the shortage persists” and acted in a way that was arbitrary, capricious and contrary to law.

It also asked the court to vacate the FDA’s action. Additionally, it sought to prevent regulators from taking action against drug compounders who lawfully produce semaglutide under circumstances when the drug has limited availability.

This marks the second time OFA has pursued legal action against the FDA over compounded drugs. In October 2024, the group sued the agency over the removal of tirzepatide from the shortage list. Tirzepatide is the active ingredient in Eli Lilly’s weight loss drug Zepbound and diabetes medication Mounjaro.

Two months ago, Pittman rejected an injunction by OFA that would have allowed compounding pharmacies to keep making their versions of tirzepatide.

A ‘data-based decision’

Commenting on Pittman’s latest decision, Steve Benz, corporate vice president, general counsel at Novo Nordisk, said, “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.”

“FDA’s determination was based on a thorough review of Novo Nordisk’s stable and growing supply of these important FDA-approved medicines. With the end of the shortage of Wegovy and Ozempic, no patient should have to be exposed to unsafe, inauthentic ‘semaglutide’ drugs.

“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. We will continue driving these actions forward and escalate our efforts as necessary, while closely engaging with regulators and law enforcement,” he said.

With the end of the shortage of Wegovy and Ozempic, no patient should have to be exposed to unsafe, inauthentic ‘semaglutide’ drugs.
– Steve Benz, corporate vice president, general counsel, Novo Nordisk

The Swiss drugmaker has its U.S. headquarters in Plainsboro. The company also said it has filed 111 lawsuits in federal courts across 32 states to stop the marketing and sale of what it describes as knockoff or misbranded compounded versions.

Novo Nordisk has said it has invested $6.5 billion over the past year domestically to increase manufacturing capacity of Wegovy and Ozempic. It has also introduced lower-cost options to better compete with compounders.

In a statement to Fierce Pharma, Lee Rosebush, chairman of the OFA, said, “We are 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. We look forward to the opportunity to introduce this evidence again through the legal process and in discussions with the FDA.”