Novo Nordisk, the Danish pharmaceutical company renowned for its diabetes and weight-loss medications, Ozempic and Wegovy, has initiated legal proceedings against certain U.S. compounding pharmacies. The company alleges that these pharmacies are producing and distributing unauthorized and potentially impure versions of semaglutide, the active ingredient in its flagship drugs.​

Legal Actions Detailed

On November 30, 2023, Novo Nordisk filed lawsuits against two Florida-based pharmacies: Wells Pharmacy Network and Brooksville Pharmaceuticals. The company claims that tests revealed these pharmacies were selling products labeled as semaglutide that contained unknown impurities—up to 33% in some cases—posing potential safety risks to consumers, including serious and life-threatening reactions such as anaphylaxis. Additionally, Brooksville Pharmaceuticals allegedly sold products with semaglutide concentrations at least 19% lower than advertised, potentially compromising efficacy. Wells Pharmacy Network is also accused of incorporating BPC-157, a substance banned by the U.S. Food and Drug Administration (FDA) due to insufficient safety data, into its formulations. ​

These lawsuits are part of a broader strategy by Novo Nordisk to protect its intellectual property and ensure patient safety. To date, the company has filed 12 legal actions against medical spas, weight loss clinics, and pharmacies allegedly involved in the unlawful sale of unapproved semaglutide products, securing preliminary injunctions in six cases. ​

FDA's Stance and Actions

The FDA has expressed concerns regarding compounded versions of semaglutide. In May 2024, the agency issued warnings about the safety risks associated with unauthorized semaglutide products after receiving reports of adverse health reactions. The FDA emphasized that compounded drugs do not undergo the same rigorous safety, quality, and effectiveness evaluations as approved medications, potentially exposing patients to significant health risks. ​

Furthermore, the FDA has taken action against specific compounding pharmacies. For instance, in November 2024, the agency warned patients and healthcare professionals not to use drugs compounded and distributed by Fullerton Wellness LLC due to concerns about sterility and potential contamination. The FDA's inspection revealed that Fullerton Wellness used non-sterile ingredients to make injectable drugs, including semaglutide, without proper sterilization processes, thereby introducing health risks. ​

Market Dynamics and Novo Nordisk's Response

The popularity of GLP-1 receptor agonists like Ozempic and Wegovy has led to increased demand, resulting in shortages and the emergence of compounded alternatives. Compounding pharmacies have been producing versions of these drugs, sometimes using unauthorized or impure ingredients, to meet patient demand. However, the FDA has clarified that with the stabilization of the national GLP-1 supply, pharmacies must adhere strictly to regulatory standards, and unauthorized compounding should cease. ​‍

In response to market challenges and to provide patients with more affordable options, Novo Nordisk announced on March 24, 2025, that all eligible cash-paying customers in the United States could purchase Wegovy at a discounted price of $499 per month at local pharmacies. This move aims to make the medication more accessible and to counter the proliferation of compounded versions. Previously, Wegovy was available at a discounted rate only through Novo's NovoCare Pharmacy program. ​

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Novo Nordisk's legal actions underscore the company's commitment to safeguarding its intellectual property and ensuring patient safety. The proliferation of unauthorized and potentially unsafe compounded semaglutide products poses significant health risks. Patients are advised to verify the authenticity of their medications and consult healthcare professionals regarding any concerns.

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