Eli Lilly is filing a fresh round of lawsuits against medspas, wellness centers and other entities that it claims are selling compounded versions of its tirzepatide-based drugs Mounjaro and Zepbound.
The US drugmaker said it plans to take legal action against six alleged sellers — Capitol Contours, Houston Weight Loss Center, Cleveland Health, Lucy’s Laser & Medspa, Metabolic MD and Stuart Lerner MD.
In a Thursday press statement, Lilly said the defendants are selling “unapproved compounded products containing what they claim is tirzepatide.” In advertising materials, they refer to the products as Mounjaro or Zepbound, cite Lilly’s clinical trial data or reference Lilly’s FDA approvals, even though the compounded drugs were not studied or approved. These actions amount to “deceiving customers,” Lilly said.
Beyond the lawsuits, Lilly reiterated in an 11-page open letter that its GLP-1s are not meant for cosmetic weight loss or people under 18 years. It also called out social media posts, videos and ads that encourage people to use tirzepatide labeled for “research purposes only” and “not for human consumption.” The open letter included images of authentic Mounjaro and Zepbound injections to help consumers spot fake or counterfeit products.
Compounded drugs are legal in some circumstances but are not FDA-approved, and using them unnecessarily can be risky, according to Lilly.
“Passing defendant’s compounded drugs off as Lilly’s Mounjaro and Zepbound is not merely deceptive — it’s dangerous,” Lilly said in its legal documents, which have not yet been filed. The drugmaker added it does not supply tirzepatide to compounding pharmacies or other manufacturers, and “does not know where compounding pharmacies or other sellers are obtaining the tirzepatide active ingredient they are selling.”
Diabetes treatment Mounjaro made $1.81 billion in the first three months of the year, while weight loss therapy Zepbound brought in $517.4 million in the same period, according to a company release.
Nearly all doses of both products were in short supply through the second quarter as the Indianapolis pharma struggled to keep up with high demand. In April, all but one dose of each drug — 2.5 mg Mounjaro and 2.5 mg Zepbound — were listed as having “limited availability” by the FDA. But now, half of all Mounjaro and Zepbound doses — three out of six for each — are described as “available.”
Thursday’s announcement follows a similar string of lawsuits submitted last September and October. In one case against importer AustroPeptide, tests showed that the company was distributing nothing more than glucose alcohol, according to Lilly’s suit.
Lilly has since secured settlement deals with several defendants featuring undisclosed payments and obligatory corrective actions.
Elsewhere, Novo Nordisk is similarly taking legal action against entities hawking compounded versions of its GLP-1s. In February, a federal court stopped two Florida wellness centers from using Novo’s Ozempic, Wegovy and Rybelsus brand names to market compounded products containing the active ingredient semaglutide.