Eli Lilly and Company (LLY) has taken a decisive stance against the unauthorized sale of tirzepatide, the active ingredient in its popular weight-loss drug, Zepbound. The pharmaceutical giant has filed lawsuits against several medical spas and online vendors for allegedly selling counterfeit versions of the drug, despite the recent resolution of a tirzepatide injection shortage declared by the FDA earlier this month.
Eli Lilly has issued numerous cease-and-desist letters to telehealth companies, compounding pharmacies, and medical spas, demanding an immediate halt to the production, sale, and promotion of products mimicking its weight-loss medications, Mounjaro and Zepbound. The company asserts that the resolution of supply issues does not impact its legal action against companies like Pivotal Peptides, MangoRx, and Genesis Lifestyle Medicine of Nevada. Eli Lilly insists that these vendors are offering counterfeit versions of tirzepatide without proper FDA approval.
Reuters, citing lawsuits filed in federal and state courts across Indiana, Texas, and Washington, reports that the medical spas and online vendors are accused of engaging in misleading advertising practices and promoting products with false claims of containing tirzepatide. The company seeks court orders to cease the sales of these unauthorized products and is also pursuing unspecified monetary damages.
In a recent development, the National Community Pharmacists Association and Alliance for Pharmacy Compounding highlighted the FDA’s statement regarding the tirzepatide shortage. The FDA clarified that while the shortage has been resolved, they do not intend to take action against the plaintiffs in the case for violations of the Federal Food, Drug, and Cosmetic Act for a period of two weeks following their decision. This period allows the FDA to re-evaluate the situation.
Eli Lilly’s legal action against these vendors underscores the company’s commitment to protecting its intellectual property and ensuring the safety and integrity of its products. It also reinforces the importance of consumers being vigilant about sourcing medications from reputable and authorized sources. As the demand for weight-loss medications continues to rise, the fight against counterfeit drugs remains a crucial battleground for pharmaceutical companies and regulatory agencies.