Eli Lilly Files Lawsuits Against Clinics Selling Fake Mounjaro Diabetes Drug

Eli Lilly has filed lawsuits against 10 medical spas, wellness clinics, and compounding pharmacies in the United States. It is alleged that these facilities have been selling unauthorized and cheaper versions of Eli Lilly’s diabetes drug, Mounjaro.

These legal actions have been taken by Eli Lilly in response to a shortage of Mounjaro in the US, attributed to its high demand. One of the reasons for the drug’s popularity is its ability to aid in weight loss, despite not being officially approved for this use.

The lawsuits have been filed in federal courts across multiple 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 is also seeking monetary damages.

The spas, clinics, and compounding pharmacies are accused 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 US Food and Drug Administration (FDA).

Eli Lilly holds the sole patent for tirzepatide and does not supply it to external entities. It remains unclear what these facilities are actually selling to consumers.

In one of the lawsuits against Rx Compound Store, a Florida-based compounding pharmacy, Eli Lilly stated, “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 has emphasized that selling counterfeit versions of Mounjaro exposes patients to drugs that have not been proven to be safe or effective.

Rx Compound Store has not yet responded to CNBC’s request for comment regarding the lawsuit.

These legal actions by Eli Lilly come after Novo Nordisk filed several lawsuits against spas and clinics for selling compounded versions of its weight-loss drugs Ozempic and Wegovy. The FDA issued a warning regarding the safety risks of unauthorized versions of these drugs after reports of adverse reactions emerged.

Although the FDA has not issued a specific warning regarding compounded versions of tirzepatide, there has been a shortage of Mounjaro, Ozempic, and Wegovy since last year, according to the FDA’s database. Experts in the industry predict that sales of these drugs and similar weight-loss treatments could reach $100 billion within the next decade.