A US federal judge denied a bid by compounding pharmacies to continue producing copies of Novo Nordisk’s diabetes and weight-loss drugs Ozempic and Wegovy, siding with regulators who argue shortages of the active ingredient semaglutide have eased, according to Reuters.
The ruling by Texas-based Judge Mark Pittman leaves intact a May deadline for large-scale compounders to halt production, dealing a blow to an industry that had capitalised on surging demand for cheaper alternatives.
The decision, filed under seal on Thursday, follows a February lawsuit by the Outsourcing Facilities Association (OFA) challenging the US Food and Drug Administration’s (FDA) determination that Novo’s semaglutide supply now meets projected demand.
Compounders – which mix or alter ingredients to replicate brand-name drugs during shortages – had been producing hundreds of thousands of doses, often sold via telehealth platforms like Hims & Hers.
Judge Pittman’s refusal to grant a preliminary injunction mirrors his earlier stance against similar efforts to copy Eli Lilly’s Zepbound and Mounjaro. The FDA has mandated that larger “outsourcing facilities” cease semaglutide production by 22 May, while smaller pharmacies must stop immediately.
However, OFA chairman Lee Rosebush criticised the ruling, claiming new evidence of ongoing shortages was ignored.
We are obviously disappointed with this initial decision and believe the data shows that there is still a shortage of these products.
Novo Nordisk and the FDA maintain that supply now outstrips demand, with the Danish pharma giant previously backing the regulator’s assessment in court filings. The FDA had paused enforcement pending the court’s decision but now faces pressure to clamp down on unauthorised versions.
