Big compounders will have until May 22 to stop producing and dispensing compounded semaglutide, while smaller, state-run pharmacies must immediately stop making copies of the blockbuster drug.
A Texas judge ruled against compounding pharmacies Thursday, rejecting a request for an injunction and blocking their bid to continue producing their copycat versions of Novo Nordisk’s blockbuster GLP-1 therapy semaglutide, according to reporting from Reuters.
District Judge Mark Pittman took the side of the FDA, which in February announced that the shortage of semaglutide—marketed as Ozempic for type 2 diabetes and as Wegovy for chronic weight management—was officially over. Compounders sued the FDA a day later, asking the court for an injunction and a declaration that the agency’s move was unlawful.
The case was brought by the Outsourcing Facilities Association (OFA), a trade group that represents FDA-sanctioned compounding pharmacies, which said that ending the shortage was a “reckless and arbitrary decision.” The plaintiff also alleged that the FDA made its move to “benefit special interests, raise drug prices, and deprive much of the public access to a needed medicine.”
Pittman did not buy these arguments, but with his ruling filed under seal, his exact reasoning for denying the injunction is unknown.
With Pittman’s verdict, large compounders will still have only until May 22 to comply and stop producing their versions of semaglutide. Smaller, state-licensed pharmacies must immediately stop making copies.
Novo has long been strongly opposed to compounding. In June 2023, for instance, the pharma sued a handful of wellness clinics and medical spas selling unapproved versions of its drug, culminating in a legal victory in February 2024. In October that year, Novo also petitioned the FDA to add semaglutide to the regulator’s Demonstrable Difficulties for Compounding, which enumerates drugs that are too complex to be compounded and which could result in substantial safety risks if incorrectly manufactured.
The OFA’s case regarding semaglutide mirrors its lawsuit in October 2024 alsotargeting the FDA but this time over Eli Lilly’s tirzepatide. The FDA at the time had similarly declared the end of a tirzepatide’s shortage, a move that the OFA also slammed as being “without meaningful rationale.” The OFA’s complaint ended in failure, with the FDA last December affirming that the tirzepatide shortage was indeed over.
Lilly wasted no time in capitalizing on this victory. On Thursday, the pharma sued four telehealth providers which were allegedly selling compounded tirzepatide, engaging in deceptive marketing tactics to make it seem like their products were approved or backed by clinical studies.
