A pharmacist displays boxes of Ozempic, a semaglutide injection drug used for treating type 2 diabetes made by Novo Nordisk, at Rock Canyon Pharmacy in Provo, Utah, March 29, 2023.
George Frey | Reuters
The actions come as Eli Lilly grapples with a shortage of Mounjaro in the U.S. due to skyrocketing demand. Much of the drug's popularity comes from its off-label ability to help patients lose unwanted pounds.
Eli Lilly initiated several lawsuits in federal courts in Florida, Texas, Arizona, Georgia, Minnesota, South Carolina and Utah. The litigation asked the courts for orders blocking the sales of counterfeit versions of Mounjaro and an unspecified amount of monetary damages.
Eli Lilly specifically accuses the spas, clinics and compounding pharmacies of marketing and selling "compounded" drug products that claim to contain tirzepatide, the active ingredient in Mounjaro. Compounded drugs are custom-made versions of a treatment that are not approved by the Food and Drug Administration.
Eli Lilly is the sole patent holder of tirzepatide and does not sell that ingredient to outside entities. It's unclear what the spas and clinics are actually selling to consumers.
"Rather than invest the time and resources necessary to research, develop, and test their products in order to ensure that they are safe and effective and to obtain regulatory approval to market them, Defendant is simply creating, marketing, selling, and distributing unapproved new drugs for unapproved uses throughout Florida and fourteen other states," Eli Lilly wrote in one suit against Rx Compound Store, a compound pharmacy based in Florida.
Eli Lilly, in the suit, added that selling counterfeit versions of Mounjaro "puts patients at risk by exposing them to drugs that have not been shown to be safe or effective."
Rx Compound Store did not immediately respond to a request for comment on the suit.
The moves come months after Novo Nordisk filed several lawsuits accusing spas and medical clinics of selling compounded versions of its highly popular weight loss drugs Ozempic and Wegovy.
The FDA in May warned about the safety risks of unauthorized versions of Ozempic and Wegovy after reports emerged of adverse health reactions to compounded versions of the drugs.
The FDA has not issued a warning about compounded versions of tirzepatide. However, Mounjaro, Ozempic and Wegovy have all been in short supply in the U.S. since last year, according to the FDA's database.
Analysts and industry executives have said annual sales of those drugs and similar treatments for weight loss could hit $100 billion within a decade.