Novo Nordisk has secured a significant legal victory that effectively limits the ability of compounding pharmacies to market or sell less expensive, unapproved versions of its blockbuster weight loss drug Wegovy and diabetes medication Ozempic. A federal judge in Texas dismissed a request by a compounding pharmacy trade group to continue producing semaglutide copies, the active ingredient in both medications, while their legal battle with the U.S. Food and Drug Administration continues. This decision stems from a February lawsuit challenging the FDA’s stance that semaglutide is no longer considered in shortage in the United States.
During the past two years, as demand for Ozempic and Wegovy surged and access dwindled, many patients turned to compounded alternatives, especially those lacking insurance coverage. The FDA permits compounding during official drug shortages, allowing pharmacies to prepare customized versions of medications. However, these compounded drugs are not FDA-approved, raising safety concerns. Companies such as Hims & Hers began offering semaglutide copycats during the shortage, but the FDA and drug manufacturers have remained wary due to the risks associated with unregulated products.
Novo Nordisk praised the ruling, emphasizing that patient safety remains its top concern. The company has pursued over 100 lawsuits across 32 states to combat what it calls illegitimate semaglutide products. U.S. District Judge Mark Pittman’s latest ruling denies the compounding trade group’s request for a preliminary injunction, allowing the FDA to take immediate enforcement action against 503A pharmacies. These are state-regulated pharmacies that compound drugs based on individual prescriptions.
After May 22, the FDA can also begin enforcing regulations against 503B outsourcing facilities, which produce compounded drugs in bulk. These facilities fall under federal oversight and may face product seizures or warning letters. The court’s decision reinforces the FDA’s authority to regulate the use of semaglutide now that the shortage has officially ended.
This marks the second legal win for Novo Nordisk within a single week. Another federal court permanently barred a 503A pharmacy, MediOak Pharmacy, from marketing or distributing compounded semaglutide. Novo Nordisk and Eli Lilly have taken a firm stance against compounding pharmacies as they defend the commercial integrity of their high-demand diabetes and weight loss medications. Eli Lilly has followed a similar legal path involving tirzepatide, the active ingredient in Mounjaro and Zepbound, with the FDA similarly declaring that shortage resolved. The compounding trade group’s challenge to the FDA’s tirzepatide ruling is now under appeal, following a separate loss in court earlier this year.
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