Eli Lilly Sues Strive and Empower Over Unapproved Tirzepatide Products

The lawsuits claim false marketing of compounded drugs as safer and more effective alternatives to FDA-approved treatments, marking a key legal test post-shortage resolution.

• Eli Lilly has filed lawsuits against Strive Pharmacy LLC and Empower Clinic Services LLC for selling unapproved tirzepatide-based products.
• The lawsuits allege that the companies falsely marketed their compounded drugs as safer and more effective than Lilly's FDA-approved medications, Zepbound and Mounjaro.
• Empower is accused of citing Lilly's clinical studies to falsely suggest the efficacy of its compounded products, including oral and injectable versions with added vitamins.
• The legal actions, filed in Delaware and New Jersey, represent the first major test of Lilly's ability to enforce restrictions on compounding pharmacies following the FDA's resolution of the tirzepatide shortage.
• Lilly also plans to send cease-and-desist letters to approximately fifty other compounders and telehealth companies to ensure compliance with FDA regulations.

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