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By Patrick Wingrove
(Reuters) - Eli Lilly said on Monday it sued three medical spas and online vendors for selling products claiming to contain tirzepatide, the main ingredient in its popular weight-loss medicine Zepbound, including in the form of dissolvable tablets.
The new lawsuits, which name Pivotal Peptides, MangoRx and Genesis Lifestyle Medicine of Nevada, are the first related to copycat tirzepatide filed since the U.S. Food and Drug Administration took the drug off its list of medicines in short supply earlier this month.
Lilly said these lawsuits were not in any way contingent on tirzepatide coming off of that list and could have been filed regardless of whether supply issues had been resolved.
Pivotal Peptides says it offers research grade tirzepatide, while MangoRx sells a compounded version, both online. Medical spa Genesis sells and administers compounded versions of the drug, according to the lawsuits.
Lilly has accused Pivotal Peptides of selling products claiming to contain tirzepatide directly to patients without any prescription from a medical professional, despite advertising the drugs for research purposes.
The lawsuits were filed in federal and state courts in Indiana, Texas and Washington, accusing each defendant of false advertising and promotion. Lilly said it sent a cease and desist letter to Pivotal Peptides before filing the lawsuit.
"Lilly is bringing these actions to protect American consumers from direct patient safety risks," said a spokesperson for the drugmaker, adding that the defendants were making false claims about efficacy or safety, and misleading consumers about the clinical data used to back them.
The Indianapolis-based drugmaker has already sued more than two dozen medical spas, wellness centers and compounding pharmacies for selling products claiming to contain tirzepatide, which is also approved to treat type 2 diabetes under the brand name Mounjaro.
In its most recent filings, Lilly said MangoRx was selling an oral version of tirzepatide branded as Trim, despite the lack of any study showing that formulation to be safe and effective. The FDA to date has only approved tirzepatide as an injectable drug.
After Lilly sent Pivotal Peptides a cease and desist letter, the vendor changed its website to say it was under maintenance and altered its operations to sell via email, social media, and word of mouth, according to the drugmaker's lawsuit.
Lilly said Genesis was claiming to sell compounded tirzepatide with vitamin B12, and that such combinations are "untested, unproven, and expose consumers to an unjustifiable risk of harm."
Eli Lilly is seeking court orders barring the vendors from selling their drugs claiming to contain tirzepatide and unspecified monetary damages.
(Reporting by Patrick Wingrove; Editing by Bill Berkrot)
