With the surge in demand for GLP-1 diabetes and weight loss drugs—and companies struggling to supply them—it was only a matter of time before knockoffs reached the market.
Early this summer, Novo Nordisk filed lawsuits accusing several companies of producing and selling compounded versions of Ozempic and Wegovy. Now, Eli Lilly has done the same, taking action against companies that the Indianapolis drug giant claims are marketing unauthorized copycats of its blockbuster Mounjaro.
Tuesday, Lilly filed eight complaints in five states against companies that it claims are making or selling compounded forms of Mounjaro, which is also known as tirzepatide. The Indianapolis-based company said two more lawsuits are in the works.
Lilly is pursuing four compounding pharmacies—Revive Rx of Texas plus Florida companies Better Life Pharmacy, Rxcompoundstore.com and Wells Pharmacy Network—for producing knockoffs of Mounjaro.
Lilly also has filed lawsuits against four companies selling compounded versions of the drug—Renew Medspa of Minnesota, Revival Aesthetics and Wellness of Utah, Graze Anatomy & Associates of Texas and Georgia Weight Loss & Aesthetics.
“Lilly cannot validate the safety or effectiveness of products claiming to contain tirzepatide that are not our own branded product,” the company said in a statement posted on its website. “Because of this, Lilly filed lawsuits to protect patient safety and stop the unlawful marketing and sale of non-FDA approved compounded products fraudulently claiming to be Mounjaro.”
In its complaint against Renew Medspa, for example, Lilly says that the company openly advertises Mounjaro on its website, even though Lilly does not provide the drug to the “defendant for resale or distribution.”
In the complaints, Lilly is seeking unspecified damages.
In May, the FDA warned of reports of adverse events from users of compounded versions of Ozempic and Wegovy. The agency said some compounded versions have been found to contain salt versions of the drugs' active ingredient and that those versions haven't been fully evaluated by the agency.
For its part, Lilly points out that the compounded versions of Mounjaro have not been reviewed by the FDA and could expose patients to health risks.
“We are asking that defendants should be stopped from providing drug products in violation of consumer protection laws, particularly where they promise their patients that their drugs offer the same safety profile and clinical benefits as Mounjaro,” a Lilly spokesperson said in an email.