FDA Removes Ozempic from Shortage List, Reshaping Market and 503B Landscape

The U.S. Food and Drug Administration (FDA) has officially removed Ozempic (semaglutide) from its Drug Shortage Database as of February 21, 2025, marking the end of a nearly three-year shortage that disrupted diabetes care and fuelled a booming weight-loss market [1]. This decision, following a similar move for Wegovy, signals Novo Nordisk’s success in ramping up supply—bolstered by billions in investments—and has significant implications for the US healthcare market and 503B compounding pharmacies. BPO Health, a leader in biotechnology, pharma, and sourcing solutions, is poised to guide clients through this evolving landscape.

The shortage, which began in March 2022, saw demand for Ozempic soar, with US prescriptions hitting 2.2 million in 2022 alone—a 857% increase since 2019 [2]. By October 2024, all doses were listed as “available,” and the FDA’s latest ruling confirms supply now meets or exceeds demand, per Novo Nordisk’s claims [3]. “This resolution showcases the power of strategic sourcing and biotech innovation,” says John Lyder, Director at BPO Health. “Our expertise helped clients navigate the shortage; now, we’re ready to optimize their operations in this new reality.”

For the market, the impact is twofold. Patients regain reliable access to Ozempic, stabilizing diabetes management and reducing reliance on alternatives. However, the end of the shortage curtails a lucrative niche for 503B compounding pharmacies, larger outsourcing facilities that produced cheaper semaglutide copies under FDA allowances during the crisis. These facilities, which followed stricter manufacturing guidelines than 503A peers, filled over 200,000 monthly prescriptions at times [4]. The FDA has set a May 22, 2025, deadline for 503B compounders to cease production, sparking pushback. On February 24, 2025, the Outsourcing Facilities Association sued the FDA, arguing the agency’s decision was “arbitrary and capricious” and ignored patient access needs [5].

This shift disrupts telehealth players like Hims & Hers, whose shares dropped 22% after the announcement [6], and could raise costs for patients dependent on compounded versions. “The biotech and Medtech sectors must adapt quickly,” notes John Lyder. “BPO Health’s sourcing and support services can help clients transition seamlessly.” As litigation looms and market dynamics shift, BPO Health stands ready to assist healthcare organizations with tailored solutions. Visit www.bpohealth.com to discover how we can support your needs in this transformed market.

[References]

[1] FDA Drug Shortages Database, February 21, 2025 (fda.gov)

[2] TrackDrugs, “Ozempic Statistics and Trends in 2024” (trackdrugs.com)

[3] Reuters, “Novo’s Wegovy and Ozempic Removed from FDA Shortage List,” February 21, 2025 (reuters.com)

[4] WIRED, “The Ozempic Shortage Is Over,” February 21, 2025 (wired.com)

[5] Reuters, “Drug Compounders Sue FDA Over Removal of Wegovy, Ozempic,” February 24, 2025 (reuters.com)

[6] Reuters, “Novo’s Wegovy and Ozempic Removed from FDA Shortage List,” February 21, 2025 (reuters.com).