Florida judge dismisses Lilly's tirzepatide suit against a compounding pharmacy

A federal judge in Florida has thrown out Eli Lilly's lawsuit against a compounding pharmacy that sells its own version of tirzepatide, the medicine Lilly markets for diabetes and weight loss ^[1]. The dismissal, issued Tuesday in the Southern District of Florida, is an early setback in the company's effort to shut down pharmacies making copycat versions of the drug ^[1].

U.S. District Judge Roy Altman concluded that Lilly was trying to enforce the federal Food, Drug, and Cosmetic Act through state law, authority he said rests with the FDA ^[1]. "We think Eli Lilly is using state law to enforce the terms of the FDCA," Altman wrote, describing that as a task generally "reserve[d] to the FDA" ^[1]. He added that the court would not let the company "use state law as a back door to private enforce the FDCA" ^[1].

The order also pointed to Supreme Court language stating that the statute and its regulations give the United States "nearly exclusive enforcement authority," and noted that courts around the country have generally declined to step into that role by deciding whether a party has or has not complied with the law ^[1].

The defendant is RXCompoundStore.com ^[1]. Lilly sued it and several other compounding pharmacies in September 2023, arguing they violated the FDCA by selling altered tirzepatide that the FDA has not approved ^[1]. At the time, Lilly said compounded forms could pose health risks, and described the lawsuits as an attempt to "protect patient safety and stop the unlawful marketing and sale of non-FDA approved compounded products" ^[1].

Compounded drugs are medicines that have been chemically altered or combined with other ingredients ^[1]. The FDA says altered versions of a drug can have "drastically different tolerability, safety and efficacy profiles," and the agency cannot guarantee the quality of compounded drugs ^[1]. Compounding is permitted in some narrow circumstances, such as when a patient is allergic to one component of an approved drug ^[1].

Lilly is not alone in court. Novo Nordisk, which sells Ozempic and Wegovy (both semaglutide), filed complaints over compounded semaglutide in June 2023 and again that July ^[1]. In February 2024, a Miami court in the Southern District of Florida issued a permanent injunction against Ekzotika Corporation, blocking it from suggesting that any of its compounded semaglutide products are authentic or approved by the FDA ^[1].

Why it matters for patients

The ruling does not change what compounded tirzepatide is. It has not been reviewed or approved by the FDA, and the agency does not vouch for its quality ^[1]. Mounjaro and Zepbound are the brand-name tirzepatide products that went through the approval process; compounded versions are made by different facilities and are not the same product ^[1].

What the decision does address is who gets to enforce the rules. Altman's reasoning suggests that courts may leave questions about compounded products to the FDA rather than settling them in lawsuits brought by drugmakers under state law ^[1]. The Ekzotika injunction went the other way in focus: it turned on how a seller described its product, specifically on claims that compounded semaglutide was authentic or FDA-approved ^[1]. Taken together, the two outcomes suggest that labeling and marketing language may carry as much weight in these disputes as the compounding itself.

For now, the practical situation is unchanged. Compounded tirzepatide remains available but unapproved, outside the FDA's quality guarantee ^[1]. How much of the drug is sold in compounded form, what it costs, and what is inside any particular vial have not been reported in connection with this ruling.

What happens next

The other lawsuits Lilly filed against compounding pharmacies in September 2023 are separate cases, and their status has not been reported ^[1]. It is not yet known whether Lilly will appeal or refile, whether the FDA will take its own action against RXCompoundStore.com, or what the next step in the dismissed case will be. No future court date has been disclosed ^[1].