Monday’s lawsuits from Eli Lilly are the first to be filed by the pharma since the regulator officially removed tirzepatide from its drug shortage database earlier this month.
Eli Lilly on Monday sued three retailers for allegedly selling compounded or copycat versions of its blockbuster weight loss and diabetes therapy tirzepatide, according to Reuters.
The lawsuits target the online vendors Pivotal Peptide, which offers research-grade tirzepatide, and MangoRx, which markets a compounded version of the incretin therapy. Lilly is also suing the medical spa Genesis Lifestyle Medicine of Nevada, which sells and administers compounded tirzepatide. The pharma claims that the defendants are engaged in false advertising and promotion, which could pose safety risks for patients.
Pivotal Peptide allegedly dispenses tirzepatide to its customers even without a doctor’s prescription. Lilly issued a cease-and-desist letter to the company before filing its lawsuit, according to Reuters.
Monday’s lawsuits are the first to be filed since the FDA earlier this month officially took tirzepatide off its drug shortage database. At the time, the regulator said that all doses of Mounjaro and Zepbound—tirzepatide’s brand names for type 2 diabetes and weight loss, respectively—were available, though the agency warned that some patients may still encounter limitations at the pharmacy counter due to certain retailer constraints and logistical issues.
BMO Capital Markets analyst Evan Seigerman in a note to investors called the supply update a “positive indication” for Lilly and its incretin portfolio. “With Lilly able to adequately supply current and future demand for tirzepatide, we believe it could continue to grow market share in incretin products as manufacturing continues to expand,” Seigerman wrote.
However, just days later, the FDA announced that it would reevaluate its decision to take tirzepatide off the shortage list after a complaint from the Outsourcing Facilities Association (OFA), which claimed that the regulator’s decision was “without due process of proper federal notice,” the trade group said in a statement.
“The agency’s decision will have tremendous implications across the nation for patients and physicians, as well as the outsourcing facilities that made an enormous investment to meet patient demand in light of product shortages and delays,” OFA Chair Lee Rosebush said. The association’s lawsuit is seeking to have the FDA’s supply update vacated, and to enjoin the regulator from taking any action against any of its members for selling compounded versions of tirzepatide.
The lawsuit, however, does not apply to Lilly, which has already mounted an extended legal campaign against tirzepatide copycats. Lilly’s lawsuits started in September and October 2023, when the pharma sued several wellness clinics and medical spas, and continued into June 2024.
