Novo Nordisk Secures Court Ruling Against Compounded Drug Versions
Bagsvaerd, Friday, 25 April 2025.
A federal court has favored Novo Nordisk, allowing the FDA to enforce against pharmacies making compounded versions of Wegovy and Ozempic, ensuring legal protection and supply security for these drugs.
Court Ruling Overview
On April 20, 2025, a federal judge in Texas decided in favor of Novo Nordisk (OMXCOP:NOVO_B), rejecting attempts by compounding pharmacies to continue producing versions of the company’s popular drugs, Wegovy and Ozempic. The court’s decision came after Novo Nordisk’s response to a February lawsuit from a compounding trade group that challenged the FDA’s declaration resolving the shortage of semaglutide, the active ingredient in both drugs [1][5].
Impact on Compounding Pharmacies
The ruling empowers the FDA to take enforcement actions against pharmacies that produce compounded versions of these drugs, in line with the FDA’s assertion that semaglutide’s shortage is over in the U.S [2][3]. The FDA has set a deadline of May 22, 2025, to begin targeting larger compounding facilities producing bulk amounts of semaglutide [3][4]. Smaller pharmacies, which produce compounded drugs per individual prescriptions, must cease immediately [4].
Novo Nordisk’s Legal Strategy
Novo Nordisk’s legal action is extensive, with the company having filed more than 111 lawsuits across 32 states to curb the illegal marketing and distribution of compounded versions of their proprietary drugs [5][7]. This aggressive legal stance not only protects its intellectual property rights but also aims to ensure patient safety by eliminating potentially unsafe versions of semaglutide from the market [5].
Implications for Patients and Market
With the shortage of Wegovy and Ozempic officially resolved, patients should theoretically have no need to seek compounded alternatives, which often lack FDA approval and pose health risks [1][5]. Novo Nordisk has worked to stabilize supply, and the court ruling is likely to bolster its position in the diabetes and weight-loss market, potentially impacting its stock performance favorably as it solidifies market exclusivity [2][6].