A federal court in Texas has rejected a request by producers of compounded drugs to extend their ability to manufacture knockoff versions of Eli Lilly's tirzepatide while a lawsuit plays out.
With the decision, small-scale compounders licensed by individual states must stop producing the drugs immediately, Reuters reports. Larger-scale compounders who are federally licensed have until March 19 to continue manufacturing the copycats, according to the news service.
In Fort Worth, Texas, U.S. District Judge Mark Pittman filed the decision in a sealed order Wednesday evening.
"The court’s decision confirms that Mounjaro and Zepbound are not in shortage, and Lilly’s safe, rigorously tested, FDA-approved medicines are available to meet current and anticipated patient needs," a spokesperson for Eli Lilly said in a statement to Fierce Pharma.
The ruling does not affect the compounders’ ability to produce their versions of Novo Nordisk’s semaglutide products.
The fate of the Novo drugs is in the hands of the same court, which is presiding over a lawsuit brought by compounders against the FDA. Earlier this week, the court ruled that Novo could intervene in that complaint, in which the compounders are questioning Novo’s claim that it has the wherewithal to meet the booming nationwide demand for semaglutide.
The FDA is involved because when it declares a drug is in shortage, compounding pharmacies are allowed to manufacture their copycat versions. In 2022, when Lilly and Novo could no longer answer the skyrocketing demand for the treatments, the FDA determined the drugs were in shortage.
Since then, compounders have cranked into overdrive, manufacturing the drugs for sale in spas and telehealth providers.
In October of last year, when the FDA removed Lilly’s tirzepatide from the shortage list, the Outsourcing Facilities Association (OFA) and Texas-based FarmaKeio Superior Custom Compounding filed a lawsuit, claiming that the regulator’s decision was based solely on the company’s declaration that the shortage was over.
The OFA called the FDA’s choice “reckless and arbitrary” and “lacking any semblance of lawful process.” The lawsuit also claimed that Lilly “is self-interested in monopolizing the market.”
Last month, when the FDA removed Novo’s drugs from the shortage list and gave compounders a grace period of between 60 and 90 days to halt production of semaglutide, the OFA and FarmaKeio filed another lawsuit. That complaint alleged that the FDA is “dismissing evidence that the shortage persists.”
“OFA is considering all of its options regarding the judgment, including an appeal," OFA Chairman Lee Rosebush said in a statement on Thursday. "We will not be able to comment on any particular aspect of the decision until it is unsealed by the court.”
While facing competition from the compounders, Lilly and Novo have pointed to safety risks and other uncertainties associated with the knockoff treatments, which don't undergo the same regulatory scrutiny as the branded products. The companies also have said that the compounded drugs undermine the investments they have made to develop their groundbreaking drugs.
"This decision marks the end of the road for mass compounding of risky, unapproved knockoffs that threaten the health and safety of Americans. Anyone who continues mass compounding tirzepatide is breaking the law, and we will work with regulators and law enforcement to stop it," Lilly's spokesperson added.