February 28, 2025 - The US Food and Drug Administration (FDA) has delivered a significant update, officially declaring the end of the Ozempic and Wegovy shortage. This development, while welcomed by many, raises crucial questions about the future of these medications and their impact on patient access, compounding pharmacies, and the pharmaceutical industry as a whole.

The End of the Shortage: A Closer Look

The shortage, which began in 2022, was primarily driven by an unprecedented surge in demand for GLP-1 receptor agonists, the class of drugs to which Ozempic and Wegovy belong. Novo Nordisk, the manufacturer, has responded to this demand by significantly increasing production capacity. The FDA's announcement signifies that the company is now effectively meeting or exceeding the current and projected national demand for these medications.

Impact on Compounding Pharmacies: A Transition Period

During the shortage, compounding pharmacies played a vital role in providing access to semaglutide, the active ingredient in Ozempic and Wegovy. However, with the shortage now resolved, the FDA is signaling a shift away from compounded versions. To facilitate a smooth transition for patients, the agency is granting a 60 to 90-day grace period, allowing compounding pharmacies to continue dispensing these medications during this time.

Safety Concerns and Legal Battles: Protecting Patient Health

The FDA has consistently expressed concerns regarding the safety of compounded semaglutide, citing reports of adverse events. Novo Nordisk has taken legal action against sellers of "copycat" products, filing over 100 lawsuits alleging false advertising and unfair trade practices. Similarly, Eli Lilly has pursued legal avenues against sellers of compounded Zepbound and Mounjaro. These actions underscore the pharmaceutical industry's commitment to ensuring patient safety and maintaining the integrity of FDA-approved medications.

Patient and Prescriber Guidance: Navigating the New Landscape

While the national shortage has ended, patients and prescribers should be aware that localized supply disruptions may still occur as the supply chain adjusts. The FDA strongly advises against using compounded versions of semaglutide when FDA-approved medications are available. Patients should consult with their healthcare providers to discuss their treatment options and ensure a safe and effective transition.

Remaining Shortages and the Broader GLP-1 Market

It's important to note that while the semaglutide shortage is resolved, other GLP-1 medications, such as dulaglutide (Trulicity) and some liraglutide injections, continue to experience supply constraints. This highlights the ongoing challenges in meeting the surging demand for these medications. The evolving landscape of the GLP-1 market requires careful monitoring and strategic planning to ensure patient access and safety.

Key Takeaways: A Summary of the Implications

• The Ozempic and Wegovy shortage is officially over, signaling improved access for patients.
• A 60-90 day grace period is in place for compounding pharmacies to transition.
• Safety concerns surrounding compounded semaglutide remain a priority.
• Legal battles are ongoing to protect the integrity of FDA-approved medications.
• Patients should prioritize FDA-approved medications and consult with their doctors.
• Shortages of other GLP-1 medications persist.