Novo Nordisk has filed a federal lawsuit against telehealth provider Hims & Hers Health Inc., accusing the company of selling copycat versions of its blockbuster weight-loss drug semaglutide and infringing on its patents. The lawsuit was submitted by Novo Nordisk to the U.S. District Court in Delaware on February 9.

The legal action comes less than a week after Hims & Hers announced plans to sell a compounded generic version of semaglutide at an introductory price of $49 per month. The U.S. Food and Drug Administration had previously issued a warning to the company, which led Hims & Hers to announce on February 7 that it would halt sales of the compounded semaglutide product.

Semaglutide, marketed by Novo Nordisk under brand names for weight loss and diabetes treatment, is currently the only oral glucagon-like peptide-1 (GLP-1) therapy approved for weight management. It is also prescribed for patients with type 2 diabetes.

John Cookman, Senior Vice President and Group General Counsel of Novo Nordisk, described the lawsuit as a comprehensive effort to hold Hims & Hers accountable. He alleged that the telehealth provider engaged in "large-scale marketing of unapproved semaglutide copycat products, bypassing the FDA’s gold-standard review process." Cookman emphasized that such actions endanger patients, are deceptive, and undermine the scientific innovation and regulatory framework designed to ensure the safety and efficacy of these treatments.

Novo Nordisk further stated that Hims & Hers continues to "illegally compound large quantities of copycat versions of Novo Nordisk’s FDA-approved injectable drugs," posing risks to patient health and well-being.

A representative for Hims & Hers did not immediately respond to requests for comment regarding the lawsuit.

Under FDA regulations, compounding pharmacies are permitted to sell generic versions of drugs during supply shortages. In February 2025, the agency declared that the semaglutide shortage had been resolved and set a deadline for enforcement actions against compounding pharmacies and entities producing copycat versions of Novo Nordisk’s drug.

On February 6, the FDA announced plans to restrict the use of GLP-1-based ingredients in compounded drugs sold by companies like Hims & Hers and online pharmacies, citing concerns over quality, safety, and effectiveness.