Eli Lilly opens legal push against sellers of compounded tirzepatide

Eli Lilly sued 10 medical spas, wellness clinics and compounding pharmacies on Sept. 19, 2023, alleging they sold unauthorized copies of its diabetes medicine Mounjaro ^[2]. The company filed in federal courts in Florida, Texas, Arizona, Georgia, Minnesota, South Carolina and Utah, seeking orders to stop the sales and an unspecified amount of money damages ^[2].

The cases arrived while Mounjaro was scarce in the U.S., a shortage CNBC attributed to surging demand, much of it from patients taking the drug off-label to lose weight ^[2]. Tirzepatide is Mounjaro's active ingredient. Lilly owns the patent and, according to CNBC, does not sell the ingredient to other firms, so what customers actually received is unclear ^[2].

STAT's account split the complaints by legal theory: four compounding pharmacies were accused of violating state law by selling versions that lacked FDA approval, and a set of spas and wellness centers faced claims of trademark infringement, false advertising and unfair competition for advertising products under the Mounjaro name ^[3].

In one complaint, aimed at Florida compounder Rx Compound Store, Lilly argued the defendant skipped the work of researching, developing, testing and obtaining clearance for a product and instead was "simply creating, marketing, selling, and distributing unapproved new drugs for unapproved uses throughout Florida and fourteen other states" ^[2]. Counterfeit Mounjaro, the company wrote, "puts patients at risk by exposing them to drugs that have not been shown to be safe or effective" ^[2]. Rx Compound Store did not immediately answer CNBC's request for comment ^[2].

The filings followed earlier suits by Novo Nordisk over compounded copies of Ozempic and Wegovy ^[2]. Those drugs, along with Rybelsus, are semaglutide — a different molecule from tirzepatide, made by a different manufacturer. In May 2023 the FDA warned about safety risks from unauthorized versions of Ozempic and Wegovy after reports of adverse reactions, while no comparable warning had been issued for compounded tirzepatide ^[2]. Mounjaro, Ozempic and Wegovy had all appeared on the FDA's shortage list since the prior year ^[2].

Lilly escalated on June 20, 2024, publishing an open letter and announcing additional legal action against sellers of unapproved compounded products marketed as tirzepatide ^[1]. The company said it had found products advertised under that name containing bacteria, elevated impurity levels, a pink color where its own medicine is colorless, and in some cases an entirely different chemical structure; at least one sample turned out to be only sugar alcohol ^[1]. Lilly also flagged online sellers offering pill or oral forms of "tirzepatide," noting that the FDA has approved the drug only as an injection under the skin and that no regulator has assessed oral versions ^[1].

Why it matters for patients

Compounded drugs are not FDA-approved and do not carry the same safety, quality and effectiveness assurances as approved medicines; the FDA has said they pose a higher risk to patients and that unnecessary use exposes patients to potentially serious health risks ^[1]. Counterfeit items made to resemble Mounjaro or Zepbound may hold nothing active, a different drug, an incorrect dose, or several medicines combined ^[1]. The National Association of Boards of Pharmacy has said illegal sellers are exploiting high demand and thin supply of incretin medicines to move substandard and falsified products ^[1].

Because Lilly states that it does not sell tirzepatide to outside companies, a buyer cannot confirm with the ingredient's maker what is inside a vial labeled compounded tirzepatide ^[2]. Lilly adds that Mounjaro and Zepbound are cleared only for adults with serious diseases, not for cosmetic weight loss and not for anyone under 18 ^[1].

What happens next

The amounts Lilly is seeking have not been disclosed, and no rulings in the 2023 cases have been reported ^[2]. Lilly said it settled in May 2024 with Totality Medispa, which agreed to a monetary payment and to stop conduct Lilly called misleading, and that it reached similar agreements with other med spas and wellness centers ^[1].