Novo Nordisk Lawsuits Target Semaglutide Copies
Danish pharmaceutical giant Novo Nordisk has intensified its legal battle against the sale of unapproved versions of semaglutide, the key ingredient in its blockbuster weight-loss and diabetes drugs, Wegovy and Ozempic. On Tuesday, the company announced 14 new lawsuits in the United States targeting telehealth firms, compounding pharmacies, and medical spas, including Prism Aesthetics, Mochi Health, and Fella Health, for producing compounded versions of semaglutide under the pretense of personalized medicine.
Compounding pharmacies create alternative versions of drugs by combining or altering ingredients, often to address shortages. The U.S. Food and Drug Administration (FDA) temporarily permitted compounded semaglutide when Wegovy and Ozempic were in short supply. However, after the FDA banned these copies due to safety concerns, some companies, like Hims & Hers, pivoted to offering personalized doses not available from branded manufacturers. Novo Nordisk claims these compounded drugs are unapproved, often made with unregulated foreign active pharmaceutical ingredients (APIs), and lack proof of safety or efficacy.
The lawsuits also allege that certain telehealth providers violate state laws by improperly influencing doctors’ prescribing decisions and promoting these knockoff drugs as tailored solutions. This legal action follows similar lawsuits by Eli Lilly, which targeted companies selling unapproved versions of tirzepatide, the active ingredient in its weight-loss drug Zepbound. Notably, Hims & Hers, a major telehealth provider, was not named in Novo’s lawsuits but saw its shares drop 12.4% after reporting disappointing quarterly revenue.
Scott Brunner, CEO of the Alliance for Pharmacy Compounding, defended state-licensed compounding pharmacies, arguing that Novo Nordisk’s claims misrepresent their legitimate role in addressing patient needs during drug shortages. The FDA continues to monitor the safety of compounded drugs, emphasizing that only FDA-approved medications have undergone rigorous testing for safety and efficacy.
Novo Nordisk’s aggressive legal strategy underscores the growing tension between pharmaceutical giants and compounding pharmacies as demand for weight-loss drugs surges. The global market for GLP-1 receptor agonists like semaglutide is projected to reach $133.5 billion by 2030, driven by rising obesity rates and diabetes prevalence, according to industry reports. These lawsuits highlight the challenges of balancing innovation, patient access, and regulatory oversight in the rapidly expanding weight-loss drug market.
