Judge Restricts Copycats of Novo Nordisk’s Weight Loss Drug

A federal judge refused to allow drug compounders to keep making copycats of Novo Nordisk A/S’s weight loss drug while a lawsuit plays out over the FDA’s decision to determine that the drug is no longer in shortage.

Judge Mark T. Pittman of the US District Court for the Northern District of Texas denied Thursday a motion for preliminary injunction from the Outsourcing Facilities Association and FarmaKeio Custom Compounding that would have blocked the Food and Drug Administration from enforcement while a lawsuit unfolds.

The order is currently sealed, but the court will issue an opinion after parties submit an agreed upon version of the order containing redactions, according to a court docket.

“We are deeply disappointed that the U.S. District Court for the Northern District of Texas 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, 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,” Rosebush said. “We will not stop in our efforts to ensure that patients can get access to this vital medication.”

The FDA on Feb. 21 determined that Novo’s blockbuster diabetes and obesity drugs Ozempic and Wegovy were no longer in shortage. That meant drug compounders—pharmacists, facilities, and others who mix ingredients to create medications in shortages—must stop producing copies of semaglutide, the active ingredient in Novo’s drug.

Drug compounders in February sued the agency, alleging it improperly declared an end to the shortage.

Pittman denied the Outsourcing Facilities Association’s motion for preliminary injunction in a separate lawsuit challenging the FDA’s decision to declare an end to Eli Lilly & Co.’s tirzepatide shortage.

The case is Outsourcing Facilities Ass’n v. FDA, N.D. Tex., No. 4:25-cv-00174, order filed 4/24/25.