Eli Lilly is stepping up its effort to combat the improper sale of compounded versions of its popular diabetes and weight loss drugs.
The Indianapolis-based drugmaker is filing lawsuits against six wellness centers, medical spas and other sellers in the United States that Lilly claims are using false advertising to “deceive patients into thinking” that they are providing “Lilly clinically studied medicines,” the complaints say.
In an updated open letter, Lilly spelled out the appropriate use of its GLP-1/GIP medicines and warned of the “potentially serious risks posed by the proliferation of counterfeit, fake, compounded and other untested versions” of its tirzepatide products Mounjaro and Zepbound.
“Compounded products may be legal in limited circumstances to address specific patient needs, but they are not FDA-approved and lack the same safety, quality, and efficacy protections as FDA-approved medicines” Lilly stressed in the letter.
Last year Lilly and Novo Nordisk each filed lawsuits against outlets that were allegedly selling off-brand versions of their weight loss products. In September, Lilly filed complaints against eight companies—including four compounding pharmacies and four medical spas—which Lilly alleged were making false claims about the Mounjaro knockoffs they were selling.
In May of 2023, the FDA warned of reports of adverse events from users of compounded versions of Novo and Lilly’s GLP-1 drugs. The agency said some of the copycats have been found to contain salt versions of the drugs' active ingredients and that those haven't been fully evaluated by the agency.
Compounding pharmacies are allowed to produce drugs that are in short supply such as Mounjaro, but they must use approved ingredients. Lilly's lawsuits, however, focus more on the sellers' advertising of these compounded drugs.
Lilly’s new complaints are against Capitol Contours of Alexandria, Virginia; Houston Weight Loss Centers of Texas; and two Ohio companies—the Cleveland Health Group and Lucy’s Laser & Mepspa.
Also facing lawsuits are Metabolic MD, which offers online telemedicine services in Ohio, Florida, Indiana and Arizona, and Honolulu doctor Stuart Lerner.
On their websites and social media posts, several of the sellers refer to tirzepatide as “FDA-approved.” Other references to their products include “generic tirzepatide” and “generic Mounjaro,” neither of which exist. None of the sellers advertise their products as compounded versions of Lilly’s drugs.
In its complaint against Metabolic MD, Lilly showed the company advertising its compounded product using a picture of Mounjaro autoinjector pens.
Last month Lilly came to an agreement with South Carolina-based Totality MediSpa, forcing the company to stop “misleading consumers into believing” that it’s selling FDA-approved Mounjaro and Zepbound.
Last year, Lilly reported combined sales of Mounjaro and Zepbound at $5.4 billion. Since 2020, the company has earmarked more than $16 billion to beef up its manufacture of the drugs. Analysts from GlobalData project sales of the tirzepatide products to hit a combined $34 billion by 2029.
With the success of the treatments, Lilly has become the most highly valued company in biopharma with its market cap skyrocketing from $115 billion to $891 billion over the last five years.