On Tuesday, Eli Lilly filed lawsuits against ten medical spas, wellness clinics, and compounding pharmacies across the U.S., accusing them of selling unauthorized, cheaper versions of the company’s diabetes drug, Mounjaro.
The lawsuits are a response to a Mounjaro shortage in the U.S., driven by surging demand. The drug’s popularity is partly due to its off-label use for weight loss.
Eli Lilly’s legal actions span federal courts in Florida, Texas, Arizona, Georgia, Minnesota, South Carolina, and Utah. The company seeks court orders to halt the sale of counterfeit Mounjaro and to obtain monetary damages.
The company alleges that these spas, clinics, and compounding pharmacies are marketing and selling “compounded” products claiming to contain tirzepatide, the active ingredient in Mounjaro.
Compounded drugs are custom-made treatments that are not approved by the U.S. Food and Drug Administration (FDA).
As the sole patent holder of tirzepatide, Eli Lilly does not sell this ingredient to external parties. It remains unclear what the spas and clinics are actually providing to consumers.
Eli Lilly’s complaint states, “Rather than invest the time and resources necessary to research, develop, and test their products to ensure they are safe and effective and to obtain regulatory approval to market them, the Defendant is simply creating, marketing, selling, and distributing unapproved new drugs for unapproved uses throughout Florida and fourteen other states.”
This statement is included in one lawsuit against Rx Compound Store, a Florida-based compounding pharmacy.
The suit further claims that selling counterfeit Mounjaro “puts patients at risk by exposing them to drugs that have not been shown to be safe or effective.”
These legal actions follow similar lawsuits filed by Novo Nordisk, which accused spas and medical clinics of selling compounded versions of its popular weight-loss drugs Ozempic and Wegovy.
In May, the FDA issued a warning about the safety risks associated with unauthorized versions of Ozempic and Wegovy after reports of adverse health reactions to these compounded drugs.
However, the FDA has not yet issued a warning about compounded versions of tirzepatide. Mounjaro, along with Ozempic and Wegovy, has experienced supply shortages in the U.S. since last year, according to the FDA’s database.
Analysts and industry executives predict that annual sales for these drugs and similar weight-loss treatments could reach $100 billion within a decade.
