Eli Lilly, the Indianapolis-based drugmaker, has filed lawsuits against 10 medical spas, wellness centers, and compounding pharmacies in the United States for selling products that claim to contain tirzepatide. Tirzepatide is an active ingredient in Eli Lilly’s diabetes drug, Mounjaro, which is expected to receive approval for weight loss later this year.
The drugmaker stated that these products, manufactured and distributed by compounding pharmacies or counterfeit sources, have not been reviewed for safety, quality, or efficacy by the US FDA or global regulatory agencies.
In the lawsuits filed in federal courts in Florida and Texas, Eli Lilly is seeking orders to prevent Better Life Pharmacy, ReviveRX, Rx Compound Store, and Wells Pharmacy Network from selling tirzepatide. The company is also seeking unspecified damages, accusing these compounding pharmacies of violating federal and state consumer protection and competition laws by selling unregulated versions of Mounjaro.
Eli Lilly is the only company with FDA approval to sell tirzepatide drugs. The company is also taking legal action against six medical spas and wellness centers in Arizona, Florida, Georgia, Minnesota, South Carolina, and Utah. These establishments are accused of infringing Eli Lilly’s trademark by advertising compounded tirzepatide as Mounjaro.
The lawsuits claim that the defendants are using Lilly’s trademark to attract customers and generate revenues by selling their own unapproved compounded drugs that supposedly contain tirzepatide for weight loss. Eli Lilly is seeking injunctive orders and damages in these cases as well.
These lawsuits follow a similar legal action taken by Novo Nordisk against medical spas and compounding pharmacies for selling products claiming to contain semaglutide, the main ingredient in their obesity treatment drug, Wegovy.
The FDA had previously issued warnings about the safety risks of using compounded or custom-made versions of weight-loss drugs like Wegovy and Ozempic. Adverse events have been reported after patients used compounded versions of semaglutide.
Industry experts predict that annual sales of weight-loss treatments like Wegovy and Mounjaro could reach $100 billion within a decade. Eli Lilly’s product could potentially account for more than half of those sales.