Eli Lilly and Company announced a settlement with Totality Medispa, which sold unauthorized compounded products mimicking Lilly’s tirzepatide drugs, Mounjaro and Zepbound. The spa falsely claimed these products had undergone clinical testing and were proven safe and effective. The settlement includes a monetary compensation and a commitment from the spa to cease using Eli Lilly’s branding and to stop selling unapproved compounded versions of the drugs.
Mounjaro, launched in mid-2022, targets type II diabetes, while Zepbound, introduced in November 2023, is aimed at treating obesity with related comorbidities. These drugs, which both contain the active ingredient tirzepatide, a dual GIP and GLP-1 receptor agonist, have quickly become significant contributors to Lilly’s revenue. They work by mimicking the GLP-1 hormone, which helps reduce weight, lower hemoglobin A1c levels, and cut cardiovascular risks.
The agreement also mandates that Totality Medispa must disclose on its website that its compounded tirzepatide products are not FDA approved and must report any adverse effects experienced by customers to regulatory authorities.
The dispute resolution occurs against a backdrop of soaring demand for obesity drugs, sometimes used cosmetically, leading to shortages. Eli Lilly has repeatedly cautioned against the use of unapproved tirzepatide products from compounding pharmacies, which may be unsafe due to contamination and high levels of impurities. These unauthorized products often vary in chemical structure and appearance from the approved drugs Mounjaro and Zepbound.
The company has pursued legal action against various entities distributing these unregulated products and stressed that Mounjaro and Zepbound should only be used for their approved medical purposes, not for cosmetic weight loss.
This issue underscores the broader challenge in the pharmaceutical industry of managing supply and demand dynamics, particularly for popular medications like obesity treatments. It also highlights the competitive pressures in the sector, with major players like Novo Nordisk and Amgen also advancing significant entries into the market with their GLP-1 receptor agonists.