A US federal judge has refused to allow small compounding pharmacies to continue selling copies of Eli Lilly’s weight-loss and diabetes drugs Zepbound and Mounjaro. The decision was made in response to a lawsuit from a compounding industry group against the FDA over its decision last year that there was no longer a shortage of the medicines’ active ingredient, tirzepatide.
The FDA had previously allowed small compounding pharmacies to produce hundreds of thousands of doses of copies of the obesity drugs while it said there was a shortage. However, with the shortage lifted, the FDA guidance states that these facilities may not produce commercially available drugs regularly or in large amounts.
In the lawsuit, the Outsourcing Facility Association argued that the FDA relied solely on statements from Lilly to determine the lack of shortage and that patients were still unable to access the drugs. The association had requested a preliminary order barring enforcement action against them while their case went forward.
However, US District Judge Mark Pittman denied this request, stating that the decision was sealed and not available for review. Lilly has stated that the decision marks the end of mass compounding of its drugs, and it plans to work with regulators and law enforcement to stop the sale of these copies.
Separately, a lawsuit by compounders over Novo Nordisk’s Ozempic and Wegovy remains pending. Insurers generally cover Lilly’s and Novo’s diabetes medications, but many do not cover weight-loss medications, leading some patients to pay out-of-pocket for compounded versions, which are typically cheaper.
Source: https://www.reuters.com/business/healthcare-pharmaceuticals/us-judge-denies-injunction-stop-bar-copies-lilly-weight-loss-drug-2025-03-06