Eli Lilly has filed lawsuits against 10 medical spas, wellness clinics, and compounding pharmacies across the United States, accusing them of selling unauthorized versions of the diabetes drug Mounjaro. The legal actions come amid a shortage of Mounjaro in the U.S., driven by surging demand, much of it for the drug’s off-label use in aiding weight loss.
The lawsuits have been initiated in federal courts in several states, including Florida, Texas, Arizona, Georgia, Minnesota, South Carolina, and Utah. Eli Lilly is seeking court orders to block the sale of counterfeit Mounjaro and monetary damages.
The accused spas, clinics, and compounding pharmacies are alleged to have marketed and sold “compounded” drug products claiming to contain tirzepatide, Mounjaro’s active ingredient. Compounded drugs are custom-made versions of treatments not approved by the U.S. Food and Drug Administration (FDA).
Eli Lilly holds the sole patent for tirzepatide and does not supply this ingredient to external entities. It remains unclear what the accused entities are actually providing to consumers.
The lawsuits argue that these businesses are “simply creating, marketing, selling, and distributing unapproved new drugs for unapproved uses,” which poses risks to patient safety by exposing them to drugs not proven to be safe or effective.
This legal action follows similar lawsuits by Novo Nordisk, which accused spas and medical clinics of selling compounded versions of their weight-loss drugs Ozempic and Wegovy. In May, the FDA warned about the safety risks of unauthorized Ozempic and Wegovy versions, although it has not issued such a warning for compounded tirzepatide. Nevertheless, all three drugs have faced shortages in the U.S. since last year, with analysts and industry experts predicting that annual sales for weight-loss drugs like these could reach $100 billion within a decade.