Eli Lilly reached a settlement with a South Carolina medical spa, marking a win in a broader legal campaign against how compounders have marketed versions of its diabetes and weight loss products.
Totality Medispa in Charleston has agreed not to use Eli Lilly’s trademarks, including in its marketing of compounded versions of tirzepatide. The drug is sold by Lilly under the brand names Mounjaro and Zepbound for diabetes and obesity, respectively. Totality will make an undisclosed payment and has committed to “conspicuously and prominently” disclosing in all of its advertisements that compounded tirzepatide is not FDA-approved, according to Lilly.
Totality owner Stanley Wilhelm said in a statement to Endpoints News that the company no longer markets compounded tirzepatide.
“Totality is a small business, and received minimal revenue from the products at issue. Totality no longer markets compounded tirzepatide, and chose to resolve the alleged dispute rather than spend time and money on protracted litigation,” Wilhelm said.
While compounded drugs are not FDA-approved, they are permitted in certain circumstances when a medicine needs to be altered in some way to meet the needs of a patient. In another instance, a drug on the FDA’s shortages list can be compounded with fewer restrictions to meet demand. But in a string of lawsuits, Lilly and GLP-1 rival Novo Nordisk have argued that compounded versions of tirzepatide and semaglutide are being marketed in misleading ways.
“Patient safety is Lilly’s highest priority. Lilly is deeply concerned that products fraudulently claimed by compounding pharmacies or counterfeiters to be FDA-approved tirzepatide, Mounjaro or Zepbound may expose patients to serious health risks,” the company said Tuesday in a news release.
The legal win comes on the heels of a pair of losses in similar cases in Florida, where separate judges tossed Lilly’s cases against two compounding pharmacies. In those cases, the drugmaker argued the defendants’ marketing of compounded tirzepatide violated Florida state law. But in the most recent decision, a federal judge said Lilly cannot “use state law as a back door to privately enforce” the Federal Food, Drug, and Cosmetic Act, which was enacted in 1938 and grants authority to the FDA to oversee and regulate new drugs.
“While this agreement is an important step forward, this is not a problem that Lilly can solve alone. We strongly support state and federal regulators taking action to deter and punish compounding pharmacies, counterfeiters, and others who put patients at risk by selling unsafe products claiming to be tirzepatide,” Lilly said.
A judge has not yet signed off on the settlement agreement.