The Food and Drug Administration recently announced that the popular diabetes and obesity drugs Mounjaro and Zepbound are no longer in shortage. This decision will prevent compounding pharmacies from creating off-brand versions of the drugs, closing a market niche that had emerged due to the high demand for these medications.
Tirzepatide, the key ingredient in both Mounjaro and Zepbound, has been in short supply since late 2022. This shortage occurred around the time Mounjaro was approved for Type 2 diabetes and its significant weight loss benefits became evident. Tirzepatide is a GLP-1 agonist, the same class of drugs that includes semaglutide, the active ingredient in Novo Nordisk’s Ozempic and Wegovy.
Both Eli Lilly and Novo Nordisk have invested heavily in expanding their production capacity for these drugs. However, until recently, they struggled to keep up with the demand. Compounding pharmacies took advantage of the shortage by producing their own versions of tirzepatide and semaglutide, selling them at lower prices than the branded medications.
Lilly and Novo have taken legal action against these compounding pharmacies, citing concerns about the quality and safety of these unapproved versions of their drugs. The FDA has also issued warnings about the risks associated with compounded GLP-1 drugs.
In early October, the FDA confirmed that Lilly had resolved the shortage of tirzepatide, making all dose forms of the drug available. Despite this, a group representing compounding pharmacies sued the FDA, claiming that the agency had not followed proper procedures in its determination. The FDA agreed to reevaluate its decision and provide an update by December 19.
The FDA’s latest decision allows a grace period before enforcement action is taken against compounding pharmacies. This period will end in February and March for different types of pharmacies. While other GLP-1 drugs like semaglutide are still in shortage, Novo recently reported that all dose strengths of semaglutide are now available.
The news of the FDA’s decision caused shares in companies like Hims and Hers Health to drop by approximately 10% in Thursday trading. Despite these fluctuations, the FDA’s efforts aim to ensure that patients have access to safe and effective medications for diabetes and obesity.
