INDIANAPOLIS (dpa-AFX) - Eli Lilly And Co. (LLY) filed lawsuits Tuesday against Strive Pharmacy and Empower Pharmacy, accusing them of unlawfully compounding and selling tirzepatide, the active ingredient in its weight-loss drug Zepbound and diabetes treatment Mounjaro.
The company claims these pharmacies are circumventing FDA regulations and misleading consumers by implying their compounded versions are as safe and effective as Lilly's FDA-approved medications.
The lawsuits, filed in federal courts in Delaware and New Jersey, escalate Lilly's efforts to curb unauthorized compounding of its drugs. While the FDA previously allowed pharmacies to produce tirzepatide-based medications due to supply shortages, it has since removed Zepbound and Mounjaro from its shortage list, prohibiting mass compounding.
However, some pharmacies continue to modify dosages or add vitamins, a practice Lilly argues is a deliberate attempt to bypass regulatory restrictions.
Empower defended its operations, stating that restricting access to compounded alternatives is not in patients' best interests.
Lilly has already taken legal action against more than two dozen medical spas and wellness centers for selling unapproved tirzepatide products. The company also plans to issue cease-and-desist letters to approximately 50 additional compounders and telehealth providers.
The outcome of these lawsuits could set a precedent for other pharmaceutical companies, including Novo Nordisk, whose obesity drug Wegovy and diabetes treatment Ozempic face similar compounding concerns after May.
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