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Flags displaying the logos of Danish pharmaceutical company Novo Nordisk, known for its popular treatments Ozempic and Wegovy, were seen during the company’s annual report presentation in Bagsvaerd, Denmark, on February 5, 2025.
A recent legal ruling has provided Novo Nordisk with a significant victory, which restricts compounding pharmacies from marketing or selling unauthorized and cheaper alternatives to its weight loss drug Wegovy and diabetes medication Ozempic.
On Thursday, a Texas federal judge dismissed a request from compounding pharmacies to continue producing copies of Ozempic and Wegovy as ongoing legal disputes concerning the drug shortages remain unresolved. This ruling follows a February lawsuit filed by a compounding trade association challenging the Food and Drug Administration’s (FDA) assessment that the active ingredient semaglutide was no longer in shortage within the U.S.
Patients turned to more affordable alternatives when the availability of Ozempic and Wegovy dwindled over the past two years, driven by surging demand and insufficient insurance coverage for the high-cost treatments.
During periods of FDA-declared drug shortages, pharmacists are permitted to create compounded versions of brand-name medications. Many telehealth services, like Hims & Hers, capitalized on this by offering these alternatives. However, pharmaceutical companies and healthcare experts have raised concerns over this practice because compounded drugs, which are tailored to meet individual patient needs as prescribed by doctors, lack FDA approval.
Novo Nordisk’s corporate vice president and general counsel for the U.S., Steve Benz, expressed satisfaction with the court’s ruling, stating, “We are pleased the court has rejected the compounders’ attempts to undermine the FDA’s data-based decision that the shortage of semaglutide is resolved.” He emphasized that patient safety is a paramount concern for the company, referencing the numerous legal measures Novo Nordisk has initiated to protect Americans from the potential dangers of counterfeit semaglutide products.
U.S. District Judge Mark Pittman’s decision specifically turned down the Outsourcing Facilities Association’s request for a preliminary injunction that would have barred the FDA from taking action against its members involved in producing compounded semaglutide. This ruling reinforces the FDA’s previous conclusion that the shortage of semaglutide has ended, allowing the agency to pursue enforcement actions against 503A pharmacies creating compounded versions of the drug for specific patients, which are primarily regulated at the state level.
Moreover, the ruling enables the FDA to initiate actions against federally regulated 503B pharmacies, which manufacture compounded drugs in bulk, starting May 22. Potential FDA actions might include product confiscations and issuance of warning letters to pharmacies.
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This recent ruling follows another success for Novo Nordisk, as a different Texas federal judge earlier this week issued a permanent injunction against MediOak Pharmacy, a 503A pharmacy, prohibiting the sale or marketing of compounded semaglutide.
Both Novo Nordisk and Eli Lilly have actively pursued legal actions against compounding pharmacies as their weight loss and diabetes medications gain remarkable traction. Eli Lilly has been involved in similar proceedings concerning tirzepatide, an ingredient in its drugs Zepbound and Mounjaro. Following the FDA’s declaration that the shortage of tirzepatide was resolved last year, the compounding trade group subsequently filed a lawsuit against the FDA. In March, a federal judge denied their request for a preliminary injunction to block the FDA’s enforcement actions regarding Mounjaro and Zepbound, and the compounding group is appealing this decision.
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