Search for a command to run...
Abstract Objectives To estimate potential launch prices of generic semaglutide following patent expiry from 2026 and to quantify the global obesity and type 2 diabetes (T2DM) burden in countries where generic access may become possible. Methods We used World Bank population data and World Obesity and Diabetes Atlas prevalence estimates to calculate obesity and T2DM burden in countries where semaglutide patents expire in 2026 or were not filed. Patent status was identified using MedsPaL and cross-checked with regional databases. We updated established cost-plus pricing methodologies using 2024-2025 Indian API shipment data to estimate production costs for oral and injectable semaglutide, incorporating formulation, packaging, taxation, and profit assumptions. Results Ten countries with 2026 patent expiry represent 44% of the global population and 48% of the global obesity burden. No patent filings were identified in 150 additional countries. By the end of 2026, generic injectable semaglutide could be distributed in 160 countries where 69% of global T2DM and 84% of clinical obesity occurs. Estimated generic injectable costs ranged from $28–140 per person-year, while oral formulations ranged from $186–380 per person-year. Injection devices contributed disproportionately to total cost. Conclusion Patent expiry could substantially expand access to semaglutide at dramatically lower prices, particularly in high-burden settings. However, device costs, secondary patents, and health system constraints may limit equitable uptake without coordinated policy action. Study Importance What is already known about this subject? Semaglutide is highly effective for obesity and cardiometabolic disease but remains unaffordable in many low- and middle-income countries due to high branded prices and patent protections. Previous cost-plus analyses show that generic competition can substantially reduce prices of essential medicines after patent expiry. What are the new findings in your manuscript? Using 2024–2025 API shipment data, we estimate generic injectable semaglutide could be produced for $28–140 per person-year following 2026 patent expiry. By 2026, generic semaglutide could be available in 160 countries comprising 69% of global T2DM and 84% of clinical obesity burden. How might your results change the direction of research or the focus of clinical practice? Provides an evidence base for procurement planning and price negotiations ahead of patent expiry. Highlights the importance of addressing device costs and secondary patents to ensure equitable global access.