A U.S. federal judge ruled on Thursday against compounding pharmacies seeking permission to continue producing copies of Novo Nordisk's widely popular diabetes and weight-loss drugs, Ozempic and Wegovy, while a legal battle over drug shortages continues.

Judge Mark Pittman of the U.S. District Court in Texas rejected a request from compounders for a preliminary injunction, effectively upholding a May 22 deadline set by the U.S. Food and Drug Administration (FDA). From this date forward, large-scale compounders must stop producing the drugs. Smaller pharmacies, regulated primarily by state authorities and producing tailored prescriptions for individual patients, must immediately cease production.

Compounding pharmacies, often simply called compounders, are facilities that create customized medications by mixing, altering, or combining pharmaceutical ingredients. Compounders typically step in to produce medications when commercial drugs face shortages or when specific formulations are required to meet individual patient needs, such as unique dosages, allergy accommodations, or different delivery methods. Their role has become particularly critical during supply shortages of popular medications, providing alternatives when brand-name drugs are unavailable or insufficiently stocked.

The lawsuit originated from a February challenge filed by the Outsourcing Facilities Association, representing compounding pharmacies. The group contested the FDA's determination that the active ingredient in both drugs, semaglutide, was no longer in shortage. During shortages, compounders typically have the legal flexibility to produce replicas of brand-name medications by mixing or altering ingredients.

Compounders had produced hundreds of thousands of doses of Ozempic and Wegovy equivalents during the previously declared shortage period. These compounded medications have been widely sold by telehealth platforms, notably including Hims & Hers.

While Judge Pittman's detailed reasoning remains under seal, the denial mirrors his earlier decision involving compounding pharmacies' attempts to continue making generic copies of Eli Lilly's weight-loss drugs, Zepbound and Mounjaro.

Lee Rosebush, chairman of the Outsourcing Facilities Association, expressed disappointment to Reuters in the ruling, emphasizing that recent evidence, not considered by the judge, showed ongoing shortages of semaglutide. "We believe the data shows that there is still a shortage of these products," Rosebush stated.

Conversely, Novo Nordisk applauded the decision. "We are pleased the court rejected compounders' attempts to undermine FDA’s data-based decision," said Steve Benz, general counsel at Novo Nordisk. The pharmaceutical giant has actively litigated against unauthorized sellers of compounded semaglutide, filing 111 lawsuits across 32 states to date.

Novo Nordisk continues to dominate the market with these medications. Analysts forecast that Ozempic and Wegovy will generate approximately $20.1 billion and $14.79 billion, respectively, in global revenue for the company this year.

The FDA previously indicated it would refrain from enforcement actions against compounders until the court issued its ruling.