Pharmaceutical giant Eli Lilly has launched legal action against MangoRx and two other medical vendors for allegedly selling unauthorized versions of tirzepatide, the active ingredient in its blockbuster weight-loss drugs Zepbound and Mounjaro.
The lawsuit highlights growing tensions between major pharmaceutical manufacturers and companies offering compounded versions of popular weight-loss medications. MangoRx, which sells a product called Trim containing compounded tirzepatide, has strongly rejected Eli Lilly's allegations of improper drug copying.
"Lilly filed three lawsuits yesterday against entities engaging in conduct that poses serious risks to patient safety," an Eli Lilly spokesperson told Pharmaceutical Technology. "No one should ever be allowed to sell these untested, non-human grade or manipulated drugs to American consumers."
Regulatory Context and Compounding Controversy
The legal dispute unfolds against a complex regulatory backdrop. While FDA-approved drugs can be compounded under specific conditions such as drug shortages, the FDA removed tirzepatide from its shortage list on October 2, 2023. However, in an unexpected move, the agency recently announced it would continue allowing pharmacists to compound tirzepatide versions while reconsidering this decision.
MangoRx markets Trim as using an "innovative formula, using the power of Tirzepatide" for weight loss. Eli Lilly contends there is no evidence supporting the safety and efficacy of this compounded product, particularly noting that the FDA has not approved any oral version of tirzepatide.
Legal Implications and Company Responses
MangoRx has announced its intention to "vigorously defend itself in this matter," stating it remains committed to offering innovative patient care while maintaining compliance with regulatory guidelines. The company joins a growing list of over 20 medical spas, wellness centers, and compounding pharmacies that Eli Lilly has sued in the past year.
The lawsuit also names Pivotal Peptides and Genesis Lifestyle Medicine as defendants for allegedly selling tirzepatide-containing products. For Eli Lilly, these legal actions represent efforts to protect a valuable asset – global sales of Mounjaro/Zepbound are projected to exceed $32 billion by 2030.
Patient Safety and Industry Oversight
Eli Lilly's spokesperson emphasized the company's commitment to addressing patient safety risks from mass-produced, untested drugs, calling for stronger regulatory action: "We once again call upon state and federal regulators and law enforcement to take decisive action against those that threaten the health and wellbeing of Americans."
The situation highlights the broader challenges facing the weight-loss drug market, where high demand has led to shortages of FDA-approved products like Zepbound and Novo Nordisk's Wegovy, creating opportunities for compounding pharmacies to fill the gap – sometimes raising significant safety and regulatory concerns.
