Lilly launches US legal offensive as tirzepatide copies proliferate
20 Jun 2024
Patent InfringementBiosimilar
Eli Lilly is ramping up efforts to combat the rising tide of unauthorised tirzepatide products, filing "several" legal actions in the US against med-spas, wellness centres and other entities allegedly selling unapproved compounded versions of its blockbuster GLP-1/GIP receptor agonistGLP-1/GIP receptor agonist. The drug is marketed as Mounjaro for diabetes and as Zepbound for weight-loss management.
The company disclosed the lawsuits in an open letter released Thursday, warning patients and healthcare providers about the "potentially serious risks posed by the proliferation of counterfeit, fake, compounded, and other unsafe or untested versions" of its FDA-approved tirzepatide medications.
Shortages persist
Lilly launched a series of lawsuits toward the end of last year aimed at preventing several US businesses, including compounding pharmacies, from cashing in on the drug. Increased demand for Mounjaro and Zepbound has triggered shortages for both products for months. While the situation appears to have eased somewhat since April, as of Thursday, half the dosage strengths of each drug are expected to continue experiencing limited availability through the end of June, according to the FDA's drug shortages database.
In its open letter, Lilly said it has "discovered compounded drugs advertised as tirzepatide with safety, sterility, and efficacy problems. Some have contained bacteria, high impurity levels… or a completely different chemical structure than [our] FDA-approved medicines. In at least one instance, the product was nothing more than sugar alcohol."
The company's legal actions allege the defendants are engaging in deceptive practices, including misleadingly referring to their products as Mounjaro/Zepbound or claiming they are equivalent. Lilly also accuses them of deceiving consumers into believing the compounded drugs were part of its clinical trials and that the FDA approvals of Mounjaro/Zepbound extend to their compounded products.
Further, the drugmaker noted that some online pharmacies are now advertising compounded pill or other oral versions of tirzepatide, whereas the FDA has so far only approved the drug for subcutaneous injection.
String of lawsuits
The latest legal offensive comes on the heels of Lilly's settlement last month with Totality Medispa, a South Carolina-based medical spa accused of misleading consumers into believing it was selling genuine tirzepatide-based medicines. The agreement required Totality to make a monetary payment to Lilly and prohibited it from making any claims suggesting it sells products from the company.
The company's crackdown follows similar efforts by rival Novo Nordisk to combat the sale of copycat versions of its blockbuster semaglutide drugs Ozempic and Wegovy, indicated for diabetes and obesity, respectively. In February, Novo Nordisk settled two lawsuits against Florida businesses selling purported compounded semaglutide products.
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