Eli Lilly, the pharmaceutical company, announced on Thursday that it has initiated legal action against six additional entities, including medical spas and wellness centers, for selling products falsely claiming to contain tirzepatide, the active ingredient in its popular diabetes medication, Mounjaro.

Tirzepatide, marketed as Zepbound for weight loss, received FDA approval late last year, granting Eli Lilly exclusive rights to distribute this drug in the United States. The company is the sole entity authorized by the FDA to sell tirzepatide, emphasizing its strong stance against unauthorized sales and distribution.

In six separate lawsuits filed in the courts of Ohio, Texas, Hawaii, and the District of Columbia, Eli Lilly alleges that these entities have misled consumers by falsely asserting that their compounded versions of tirzepatide are FDA-approved. The pharmaceutical company has raised concerns about the safety and efficacy of these unverified products, warning that untested and potentially unsafe compounded tirzepatide poses significant risks to patients.

Eli Lilly has also expressed alarm over the growing number of online sales and social media posts promoting counterfeit versions of its medication. The demand for GLP-1 drugs, including Novo Nordisk’s Wegovy and Eli Lilly’s Zepbound and Mounjaro, has been outstripping supply. According to the FDA, some doses of Mounjaro and Zepbound are expected to be available only in limited quantities through the second quarter of the year.

This legal action is part of a broader effort by Eli Lilly and its Danish competitor Novo Nordisk to combat the unauthorized sale of products containing tirzepatide and semaglutide, the active ingredients in their respective weight-loss drugs. Both companies have previously taken legal action against several entities to halt the distribution of counterfeit medications.

In May, Eli Lilly reached a settlement with Totality Medispa, which involved a monetary payment to the drugmaker and the implementation of corrective measures. Lilly has reported entering similar settlements with other medical spas and wellness centers that have falsely advertised their products in the past.

The FDA has issued warnings about the dangers associated with the use of compounded or custom-made versions of popular weight-loss drugs. Although the FDA's guidelines permit the manufacturing and distribution of compounded drugs under specific circumstances, such as when the original drug appears on its drug-shortage list, these versions are subject to fewer restrictions, raising concerns about their safety.

Eli Lilly's proactive legal actions underscore its commitment to safeguarding patient safety and maintaining the integrity of its FDA-approved medications. The company continues to monitor the market for unauthorized products and take necessary steps to protect consumers from potentially harmful counterfeit drugs. This vigilance is essential in ensuring that patients receive only safe and effective treatments as approved by regulatory authorities.