Eli Lilly Suffers Legal Loss For Its Popular Weight Loss/Diabetes Drug In Lawsuit Against Florida Compounding Pharmacy

U.S. District Judge Roy Altman ruled that the drugmaker Eli Lilly And Co LLY cannot rely on state law to stop a compounding pharmacy, RXCompoundStore.com, from marketing its version of the drug tirzepatide. 

Eli Lilly markets tirzepatide as Mounjaro for diabetes and Zepbound for weightloss.

According to Judge Altman, Lilly’s attempt to prevent this through the courts was seen as an effort to circumvent federal law.

“We think Eli Lilly is using state law to enforce the terms of the FDCA [Federal Food, Drug, and Cosmetic Act], which … is a task generally ‘reserve[d] to the FDA,'” Altman wrote, adding that the court will not allow Lilly “to use state law as a back door to private enforce the FDCA.”

“As the Supreme Court has made clear, ‘the FDCA and its regulations provide the United States with nearly exclusive enforcement authority,'” the judge’s ruling states. “Given the federal government’s ‘nearly exclusive’ authority to enforce the FDCA, courts around the country have generally refused to encroach on that authority by adjudicating claims that a party has (or has not) complied with the FDCA.”

In September 2023, Eli Lilly announced legal action against ten entities in the U.S., including medical spas, wellness centers, and compounding pharmacies, alleging that they have been selling unauthorized, less expensive versions of Mounjaro.

In March, the U.S. pharma giant revealed that it has identified bacteria and elevated impurity levels in products falsely claiming to be compounded versions of tirzepatide, the active ingredient in its widely-used diabetes medication Mounjaro and the weight loss treatment Zepbound. 

Lilly competitor Novo Nordisk A/S NVO, which markets Ozempic and Wegovy, has also been going after compounding pharmacies and wellness clinics for selling altered versions of semaglutide. 

In November 2023, Novo Nordisk announced a legal action against Florida compounding pharmacies, suing one and refiling a lawsuit against another, as it discovered impurities in their products claiming to contain the active ingredient, semaglutide, for its popular weight-loss drug Wegovy. 

The Danish drugmaker found these impurities to be as high as 33% in some instances, raising concerns about the safety and efficacy of the compounded drugs.

Price Action: LLY shares are up 0.15% at $760.76 on the last check Friday.

Wegovy. Image Via Shutterstock