Makers of knockoff in-demand weight loss drugs are fast running out of options to manufacture them legitimately as a federal court this week dismissed an attempt by compounding pharmacies to continue to produce copycats of Novo Nordisk’s semaglutide while a lawsuit plays out.

In Texas, U.S. Judge Mark Pittman has rejected a preliminary injunction, filing his decision Thursday in a sealed order, according to Reuters.

The ruling means that small-scale compounders must immediately stop making their versions of Novo’s Ozempic and Wegovy, while larger, federally licensed compounders have until May 22 to keep producing the copycats, as specified by the FDA two months ago.

Thursday’s decision was a replay of Pittman’s ruling seven weeks ago, when he rejected an injunction by compounders that would have allowed them to continue to manufacture their versions of Eli Lilly’s tirzepatide, the ingredient used to make branded blockbusters Mounjaro and Zepbound, as another lawsuit plods on.

The Texas court is presiding over lawsuits brought by compounders against the FDA. The compounders are questioning claims by Novo and Lilly that their drugs are no longer in shortage, a status change that means compounding pharmacies are no longer allowed under FDA rules to manufacture their copycats. 

"We are deeply disappointed that the (court) misapprehended or failed to take into consideration the clear and convincing evidence that demonstrates that the manufactured supply of semaglutide is not able to meet the enormous demand in the U.S.," Lee Rosebush, chairman of the Outsourcing Facilities Association (OFA), said in a statement. "We look forward to the opportunity to introduce this evidence again through the legal process and in discussions with the FDA.”

In 2022, when Lilly and Novo could no longer answer the skyrocketing demand for the treatments, the FDA determined the drugs were in shortage. Compounders quickly cranked into overdrive, manufacturing the drugs for sale by entities like medical spas and telehealth providers.

In October of last year, when the FDA removed Lilly’s tirzepatide from the shortage list, the 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 and calling the FDA’s choice “reckless and arbitrary."

Two months ago, 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.”

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 their branded counterparts. The companies also have said that the compounded drugs undermine the investments they have made to develop their groundbreaking drugs.

"We are pleased the court has rejected the compounders' attempts to undermine FDA's data-based decision that the shortage of Wegovy and Ozempic is resolved," Steve Benz, Novo's legal chief, said in a release. "FDA's determination was based on a thorough review of Novo Nordisk's stable and growing supply of these important FDA-approved medicines. With the end of the shortage of Wegovy and Ozempic, no patient should have to be exposed to unsafe, inauthentic semaglutide drugs."

Two weeks ago, Lilly sued an Indianapolis spa, Premier Weight Loss, claiming that it buys autoinjector pens filled with tirzepatide, cracks them open, breaking a sterile seal, and repackages them into lower, unsterile doses.