In a significant legal development, a federal court in Texas has ruled against compounding pharmacies seeking to continue producing versions of Novo Nordisk’s GLP-1 medications, Ozempic and Wegovy, using semaglutide. The ruling, issued on April 24, 2025, by U.S. District Judge Mark Pittman, denies a request for a preliminary injunction that would have allowed these pharmacies to keep manufacturing compounded semaglutide products while a lawsuit progresses. Reuters
Background: The Semaglutide Shortage and Compounding Permissions
In early 2022, the FDA declared a shortage of semaglutide, the active ingredient in Novo Nordisk’s diabetes and weight-loss drugs, Ozempic and Wegovy. This designation permitted compounding pharmacies to produce versions of these medications to meet patient demand. However, in February 2025, the FDA announced that the shortage had ended, removing semaglutide from its shortage list. Consequently, the FDA set deadlines for pharmacies to cease production: state-licensed pharmacies (503A) were required to stop by April 22, 2025, while outsourcing facilities (503B) had until May 22, 2025. Daily Medical News
Legal Challenge and Court Decision
The Outsourcing Facilities Association (OFA), representing compounding pharmacies, filed a lawsuit challenging the FDA’s decision to remove semaglutide from the shortage list. The OFA argued that the shortage persists and that compounded versions are essential for patient access, especially given the high cost of brand-name medications. Despite these claims, Judge Pittman denied the OFA’s request for a preliminary injunction, effectively upholding the FDA’s decision and enforcing the cessation deadlines. Reuters
Industry Reactions and Implications
Novo Nordisk, the manufacturer of Ozempic and Wegovy, expressed support for the court’s decision. Steve Benz, the company’s corporate vice president and general counsel, emphasized that the ruling protects patients from potentially unsafe and unregulated compounded drugs. Novo Nordisk has filed numerous lawsuits across the United States to halt the production and sale of unauthorized semaglutide products. Reuters
On the other hand, the OFA expressed disappointment, arguing that the court failed to consider evidence suggesting that a shortage still exists. The association plans to continue its legal efforts and engage with the FDA to address what it perceives as ongoing access issues. Reuters
Looking Ahead
As the May 22 deadline approaches for outsourcing facilities, the pharmaceutical industry and patients alike await further developments. The outcome of this legal battle may have lasting implications for the regulation of compounded medications and patient access to affordable treatments.
For more information on this ongoing issue, please refer to the following news articles:
Federal Court Denies Injunction in Semaglutide Compounding Case
Ozempic copies restricted after US judge denies injunction
3 days agoWIREDThe Ozempic Shortage Is Over66 days agoHealthFDA Says Ozempic Is No Longer in Shortage-Does That Mean the End of Cheaper Copycat Versions?31 days ago
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