MangoRx said it “strongly refutes” claims made by Eli Lilly that it improperly copied blockbuster weight-loss medicines for sale on its telemedicine platform.
MangoRx was responding to Eli Lily after the drugmaker sued it and two other medical spas and online vendors earlier this week for selling products claiming to contain tirzepatide, the active ingredient in Lilly’s popular GLP-1 agonist drugs Zepbound and Mounjaro.
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“Lilly filed three lawsuits yesterday against entities engaging in conduct that poses serious risks to patient safety,” an Eli Lilly spokesperson told Pharmaceutical Technology.
“No one should ever be allowed to sell these untested, non-human grade or manipulated drugs to American consumers,” they added.
MangoRx is one of those implicated in the lawsuits as first reported by Reuters, as it sells a compounded version of tirzepatide in a weight loss product called Trim. FDA-approved drugs can be compounded under certain conditions such as if the original approved drug is in shortage and unavailable. Many patients seeking GLP-1 agonists turned to compound pharmacies as demand for Zepbound and Novo Nordisk’s Wegovy (semaglutide) far-outpaced supply, leading to shortages of the FDA-approved products. The FDA removed Lilly’s tirzepatide from its drug shortage list on 2 October, removing the previous qualification granted to compounding pharmacies to manufacture copycats of the drugs.
However, last week the FDA surprisingly said it would allow pharmacists to continue making compounded versions of tirzepatide while it reconsiders its decision to remove the drug from its nationwide shortage list. Compounders are still allowed to manufacture copycat versions of Wegovy, which is still on the shortage list.
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By GlobalDataEli Lilly, which has sued more than 20 medical spas, wellness centres, and compounding pharmacies over the past year, alleges MangoRx has improperly copied tirzepatide.
The Eli Lilly spokesperson confirmed that MangoRx unlawfully touts the efficacy of its manipulated tirzepatide knockoff, adding that is not “been clinically tested, let alone reviewed by FDA for safety or efficacy.”
According to MangoRx’s website, Trim uses an “innovative formula, using the power of Tirzepatide” and “offers an effective and safe method for shedding excess weight.” Eli Lilly claims there is no evidence that this compounded drug is safe and effective; the FDA has not approved an oral version of tirzepatide.
MangoRx said it “has strong arguments against Eli Lilly’s claims and intends to vigorously defend itself in this matter.” The company added it remains committed to offering patients innovative care “while striving to comply with federal, state and local regulatory guidelines”.
Also involved in Eli Lilly’s most recent filing, were Pivotal Peptides and Genesis Lifestyle Medicine, with both companies allegedly selling tirzepatide-containing products to patients. Eli Lilly is looking to protect one of its most prized assets, with global sales of Mounjaro/Zepbound forecast to reach more than $32bn by 2030, as per analysis by GlobalData’s Pharma Intelligence Center.
GlobalData is the parent company of Pharmaceutical Technology.
“These lawsuits reflect Lilly’s continued commitment to address the patient safety risks of mass-produced, untested, and manipulated drugs. We once again call upon state and federal regulators and law enforcement to take decisive action against those that threaten the health and wellbeing of Americans,” said Eli Lilly’s spokesperson.
Note: This article was updated on 23 October to include comment from an Eli Lilly spokesperson.
