The surging demand for GLP-1 diabetes and weight loss medications has led to an inevitable influx of knockoff versions. Earlier this summer, Novo Nordisk took legal action against several companies for manufacturing and selling compounded variants of Ozempic and Wegovy. Now, Eli Lilly has followed suit, initiating legal proceedings against firms accused of marketing unauthorised replicas of its blockbuster drug, Mounjaro.
Eli Lilly filed eight complaints across five states against companies involved in producing or selling compounded versions of Mounjaro, also known as tirzepatide, with two additional lawsuits in the pipeline. The legal action targets both compounding pharmacies and companies retailing these compounded versions.
The compounding pharmacies under scrutiny include Revive Rx of Texas, as well as Florida-based entities Better Life Pharmacy, Rxcompoundstore.com, and Wells Pharmacy Network. Lawsuits have also been filed against companies selling compounded iterations of Mounjaro, such as Renew Medspa of Minnesota, Revival Aesthetics and Wellness of Utah, Graze Anatomy & Associates of Texas, and Georgia Weight Loss & Aesthetics.
Eli Lilly emphasized that it cannot vouch for the safety or efficacy of products purporting to contain tirzepatide if they are not the company’s branded product. Consequently, the lawsuits aim to safeguard patient safety and halt the unlawful promotion and sale of non-FDA approved compounded products falsely claiming to be Mounjaro. For instance, one complaint against Renew Medspa highlighted the open advertisement of Mounjaro on its website, despite Lilly not supplying the drug to the defendant for resale or distribution.
The complaints seek unspecified damages, underlining the importance of ensuring regulatory compliance and safety in the pharmaceutical market. In May, the FDA issued warnings regarding adverse events associated with compounded versions of similar drugs like Ozempic and Wegovy, underscoring potential health risks linked to unauthorized compounded products.
Eli Lilly’s legal actions are driven by the need to prevent defendants from delivering drug products that violate consumer protection laws, especially when they falsely assure patients of similar safety profiles and clinical benefits as Mounjaro, as stated by a Lilly spokesperson via email.