Lilly begins US legal action over tirzepatide copies

Eli Lilly is intensifying its efforts to address the surge in unauthorized tirzepatide products by filing multiple legal actions across the United States. These actions target med-spas, wellness centers, and other entities allegedly distributing unapproved compounded versions of its popular GLP-1/GIP receptor agonist, marketed under the names Mounjaro for diabetes treatment and Zepbound for weight-loss management.

In an open letter released on Thursday, Eli Lilly disclosed the lawsuits and issued a stern warning to both patients and healthcare providers about the "potentially serious risks" associated with the spread of counterfeit, fake, compounded, and other unsafe or untested versions of its FDA-approved tirzepatide medications. The company cited ongoing shortages of Mounjaro and Zepbound, which have persisted for months due to heightened demand.

The legal actions, initiated toward the end of last year, aim to prevent various U.S. businesses, including compounding pharmacies, from capitalizing on the drug's popularity. Although the situation has improved somewhat since April, the FDA's drug shortages database indicates that half of the dosage strengths for both medications are expected to remain in limited supply until the end of June.

Eli Lilly's open letter revealed that some compounded drugs marketed as tirzepatide have been found to have issues with safety, sterility, and efficacy. Specific concerns include the presence of bacteria, high levels of impurities, and in some cases, a completely different chemical structure than the FDA-approved medications. In one alarming instance, the product was merely sugar alcohol.

The company's lawsuits accuse the defendants of engaging in deceptive practices, such as falsely labeling their products as Mounjaro or Zepbound and misleading consumers into believing that these compounded drugs were part of Eli Lilly's clinical trials. Additionally, the lawsuits claim that these entities have falsely suggested that the FDA's approvals of Mounjaro and Zepbound extend to their compounded versions. Eli Lilly further noted that some online pharmacies are now advertising oral versions of tirzepatide, despite the FDA only approving it for subcutaneous injection.

This latest legal push follows a recent settlement with Totality Medispa, a South Carolina-based medical spa accused of misleading consumers into thinking it was selling genuine tirzepatide medications. As part of the settlement, Totality agreed to make a monetary payment to Eli Lilly and cease making any claims that its products were associated with the company.

Earlier this year, a federal judge in Florida dismissed a lawsuit by Eli Lilly against RXCompound Store, which was accused of selling unauthorized compounded tirzepatide. The court ruled that Eli Lilly had incorrectly tried to enforce federal law using state statutes.

These actions by Eli Lilly mirror similar efforts by its competitor Novo Nordisk, which has also been combating the spread of copycat versions of its blockbuster semaglutide drugs, Ozempic and Wegovy, used for diabetes and obesity respectively. In February, Novo Nordisk settled two lawsuits against Florida entities selling purported compounded semaglutide products.

Eli Lilly's intensified legal efforts underline the company's commitment to safeguarding the integrity and safety of its medications amidst proliferating unauthorized and potentially dangerous alternatives.