ABSTRACT
Objective
This study aimed to estimate potential launch prices of generic semaglutide following patent expiry in 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. Patent status was identified using MedsPaL and cross‐checked with regional databases. We applied updated cost‐plus pricing methods using 2024–2025 Indian active pharmaceutical ingredient shipment data to estimate production costs for oral and injectable semaglutide, incorporating formulation, packaging, taxation, and profit assumptions.
Results
Twelve countries with 2026 patent expiry account for 47% of obesity and 49% of T2DM globally. No patent filings were identified in 150 additional countries. By the end of 2026, generic injectable semaglutide could be available in 162 countries representing 69% of global T2DM and 84% of clinical obesity. Estimated generic injectable costs ranged from $28 to $140 per person‐year; oral formulations ranged from $186 to $380 per person‐year. Injection devices contributed disproportionately to total cost.
Conclusions
Patent expiry may substantially expand access at lower prices, but device costs, secondary patents, and health system constraints could limit equitable uptake without coordinated policy action.
Keywords: cost, generic, semaglutide, weight loss
Study Importance
- What is already known?
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○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.
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○Previous cost‐plus analyses show that generic competition can substantially reduce prices of essential medicines after patent expiry.
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- What does this study add?
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○Using 2024–2025 active pharmaceutical ingredient shipment data, we estimate generic injectable semaglutide could be produced for $28–$140 per person‐year following 2026 patent expiry.
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○By 2026, generic semaglutide could be available in 162 countries making up 69% of global type 2 diabetes and 84% of clinical obesity burden.
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- How might these results change the direction of research or the focus of clinical practice?
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○This study provides an evidence base for procurement planning and price negotiations ahead of patent expiry.
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○It also highlights the importance of addressing device costs and secondary patents to ensure equitable global access.
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1. Introduction
Overweight and obesity are a growing global public health challenge, with 1 in 8 people (2.5 billion adults) affected worldwide [1]. In 2022, WHO estimated that above‐optimal BMI contributed to 3.7 million deaths from noncommunicable diseases (NCDs), including cardiovascular disease, type 2 diabetes (T2DM), cancers, and chronic respiratory disease [1]. Seventy percent of this burden now falls on low‐ and middle‐income countries (LMICs) where NCDs now account for 82% of deaths before age 70, compounding their ongoing infectious disease burden [2]—effects influenced by the globalization of neoliberal market frameworks which entrench health disparities through their influence on trade, policy, and the social and commercial determinants of health [3]. Expanding access to GLP‐1 receptor agonists therefore has important clinical and public health implications then, for people in low‐ and high‐income countries alike.
Semaglutide, initially developed for glycemic control in T2DM, has demonstrated substantial metabolic, cardiovascular, and renal benefits in people both with and without diabetes [4, 5]. Now recognized as an effective obesity therapy and included in the WHO Essential Medicines List, it lowers HbA1c and improves glycemic control for people with T2DM [6], while also reducing weight, waist circumference, blood pressure, lipids, and inflammatory markers [7, 8]. In obesity without diabetes, weekly semaglutide 2.4 mg produces sustained mean weight loss of approximately 15% over 104 weeks versus 2.6% with placebo [7]. Trials show significant reductions in nephropathy progression and major kidney disease events, alongside reductions in major adverse cardiovascular events, improved heart failure outcomes, and lower all‐cause mortality in high‐risk populations [6, 9].
However, it is important to highlight that GLP‐1 agonists are not a panacea for obesity. A recent meta‐analysis found that although weight loss of up to 20% can be achieved during treatment, weight regain after discontinuation (averaging 0.8 kg per month) may be faster than with lifestyle‐based interventions or some oral therapies, with patients in some cases returning to pretreatment weight within 18 months, exacerbating the chronic and relapsing nature of obesity [10]. These findings raise important questions about long‐term treatment duration, adherence, affordability, and expectation management. Further research is needed to evaluate the recurrence of cardiometabolic risk following weight regain. Semaglutide and other obesity medications should therefore be considered components of a sustained, comprehensive weight management strategy rather than short‐term or standalone solutions.
Semaglutide was granted FDA approval for treatment of T2DM in 2017 (as Ozempic) and obesity in 2021 (as Wegovy) in the United States. Costs for oral semaglutide are $6936–$7716 per person‐year (ppy) and $4248–$9648 ppy for injectable formulations in the United States [11]. However, despite its clinical promise, the high price of branded semaglutide has significantly limited its access in LMICs [12], and uptake in high‐income countries has been slow due to reimbursement restrictions and out‐of‐pocket costs to users [13]. In 2024, Novo Nordisk made over $26 billion in revenue from Wegovy and Ozempic, while Eli Lilly's tirzepatide (brand names Mounjaro and Zepbound) had combined sales of nearly $16 billion. Ozempic and Wegovy ranked as the 3rd and 16th highest‐grossing pharmaceuticals worldwide in 2024 respectively, as measured by total sales revenue [14].
Patents for semaglutide are due to expire in several countries from April 2026—including India, China, Canada, Brazil, and Turkey—enabling the development and distribution of generic formulations. This shift in intellectual property rights could significantly reduce semaglutide prices and expand access globally through generic production and pooled procurement, mirroring earlier successes with generic antivirals [15] and other essential medicines [16]. Such changes are particularly important if LMICs are to benefit from the clinical benefits semaglutide confers.
2. Methods
We used World Bank population estimates and morbidity data from World Obesity and Diabetes Atlas (available in Table S1) to estimate the number of people with obesity and T2DM in countries where generic semaglutide may become available. We used the Medicines Patent Pool database (MedsPaL, https://www.medspal.org/) to determine where semaglutide patents are held and when they are due to expire and cross‐checked with regional databases where necessary.
We updated previously established and published cost‐plus pricing methodologies [16] to estimate the cost of production for semaglutide. We reviewed The Trade Vision LLC database (https://app.thetradevision.com/auth/login), examining records from November 2024 to November 2025 of semaglutide active pharmaceutical ingredient (API) imports and exports to and from India, providing shipment‐level data on quantity, price, and origin. Thirty‐three shipments of API were extracted, and a weighted mean cost/kg was calculated. Production costs were estimated using established cost‐plus methodologies, incorporating API costs and estimates for formulation, packaging, labor costs, transportation, taxation on profit (of 27%), and profit margins (of 30%), assuming efficient large‐scale generic manufacture. A full list of cost assumptions with references can be found in Table S2. The weighted mean cost/kg of API was multiplied by different approved dosing regimens for oral and injectable semaglutide.
3. Results
Figure 1 shows the countries where semaglutide will become generically available in 2026. These 12 countries, shown in orange, carry 47% of the obesity burden worldwide and 49% of T2DM. No patent filings were identified in 150 other countries. By the end of 2026, injectable generic semaglutide could be distributed in 162 countries (orange and green countries), where 69% of T2DM and 84% of clinical obesity occur.
FIGURE 1.

Choropleth map to show countries in which semaglutide patents expire in 2026.
Using cost‐plus methodologies, generic semaglutide could become available for just $28–$134 ppy for the establishment of a treatment naive patient on 1.7 mg once per week treatment or $29–$138 ppy for the establishment of a treatment naive patient on the higher dose of 2.4 mg once per week (Figure 2a). Once patients are fully established on treatment, injectable treatment is nearly identical, ranging from $28 to $135 ppy for low dose treatment (1.7 mg per week) and $30–$140 ppy for higher dose injectable treatment (2.4 mg once per week).
FIGURE 2.

(a) Cost‐plus analysis for injectable semaglutide treatment courses. (b) Cost‐plus for oral semaglutide treatment courses. (c) Cost per injectable semaglutide pen. [Color figure can be viewed at wileyonlinelibrary.com]
Oral treatment courses are more expensive, as much higher doses of the API are needed per week (Figure 2b). For treatment naive patients, generic oral semaglutide could become available for around $186 ppy for those taking 7 mg once per day and $344 ppy for those taking 14 mg once per day. For patients who are already established on treatment, each subsequent year of oral therapy would cost $193 ppy for 7 mg once per day tablets and $380 ppy for high dose treatment of 14 mg once per day.
Production cost analysis indicates that API costs are low—around $0.01 (0.25 mg) to $0.12 (2.4 mg) per dose. In contrast, disposable injection pens cost $0.30–$2.50 per device (Figure 2c; Table S2), meaning the device alone can cost 8–68 times more than the API plus all other production costs combined.
4. Discussion
Several limitations should be acknowledged. Firstly, although we used established cost‐plus price assumptions, actual production costs will vary by manufacturer, scale, and procurement conditions. Secondly, shipment prices from India capture current market transactions, not necessarily the lowest achievable cost under high‐volume global generic production—API prices usually fall over time with introduction of generic competition resulting in lower production costs [17]. Lastly, injection pens represent a major share of total cost, yet pricing data are less transparent than API data. Since 52 pens are needed per year, the affordability of generic semaglutide will depend largely on low‐cost device mass production.
Although core semaglutide patents begin expiring in 2026, Novo Nordisk has constructed an extensive “patent thicket” of more than 20 patent families comprising 220 patents across 28 countries with protections extending to 2033. Recent analysis suggests many GLP‐1 patents focus on devices rather than the drug itself, raising concerns that patents may function primarily to extend market exclusivity [18]. Intellectual property challenges from companies including Viatris and Huadong Medicine, which argued that semaglutide is too structurally similar to liraglutide to justify extended protection, have so far been unsuccessful [19]. Meanwhile, generic momentum is building: Indian and Chinese manufacturers are advancing late‐stage development, including oral formulations, and competition is expected to intensify after patent expiry [20].
Importantly, the absence or expiry of patent protection does not in itself ensure rapid generic entry, as regulatory approval requirements, data exclusivity provisions, and limitations in manufacturing, procurement, and distribution infrastructure may continue to pose significant challenges independent of patent status. Furthermore, long‐term safety, durability of weight loss and associated cardiometabolic benefits, and real‐world effectiveness in LMIC populations require continued evaluation and surveillance. In addition, current geopolitical instability is likely to increase production and distribution costs in the near term, potentially slowing the translation of lower manufacturing costs into affordable end‐user prices, irrespective of patent status.
Limited access to semaglutide risks widening global health inequalities. Without affordable pricing models or generic competition, these therapies will remain concentrated in high‐income settings despite disproportionate need elsewhere. This cost‐of‐production analysis suggests that these compounds could be manufactured for a fraction of their current price in various settings (Figure 3; Table S3), even when incorporating profit margins and distribution costs. Lower prices through generic access could enable earlier intervention for obesity, integration into primary care, and a shift from treating advanced metabolic complications toward preventing long‐term morbidity.
FIGURE 3.

Bar graph showing typical cost of branded semaglutide (Wegovy) per patient per month across various countries compared to estimated cost of production. [Color figure can be viewed at wileyonlinelibrary.com]
Crucially, pharmacotherapy cannot address the structural determinants driving obesity, including food insecurity, poverty, urbanization, and commercial food environments. Sustainable impact will require coordinated policy approaches that combine equitable medicine pricing, strengthened primary care systems, lifestyle support, and broader public health interventions. Without deliberate action on affordability and implementation, the benefits of novel obesity therapies are unlikely to reach the populations bearing the greatest burden.
5. Conclusion
Using updated API shipment data and cost‐plus pricing methods, we estimate that generic semaglutide could launch from 2026 at a fraction of current branded prices—with injectable formulations particularly affordable—in 162 countries making up 69% of T2DM and 84% of clinical obesity globally. These projections are likely conservative as API costs typically fall further with scale and competition. However, device costs, secondary patents, financing constraints, and health system barriers may limit equitable access without coordinated policy and procurement action.
Funding
This work was funded by the International Treatment Preparedness Coalition (ITPC).
Conflicts of Interest
F.V. reports receiving lecture fees and travel support from Roche, grant support, advisory board fees, and provision of drugs from Gilead Sciences, advisory board fees from ViiV Healthcare, lecture fees from Merck and Adcock Ingram, and lecture fees and advisory board fees from Johnson & Johnson. The other authors declare no conflicts of interest.
Supporting information
Table S1: References for epidemiological estimates.
Table S2: References for fixed cost assumptions used in cost+ modeling.
Table S3: References for cost estimates for 1 month supply of branded semaglutide (Wegovy) per patient.
Data Availability Statement
The data that support the findings of this study are available from the corresponding author upon reasonable request.
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Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
Supplementary Materials
Table S1: References for epidemiological estimates.
Table S2: References for fixed cost assumptions used in cost+ modeling.
Table S3: References for cost estimates for 1 month supply of branded semaglutide (Wegovy) per patient.
Data Availability Statement
The data that support the findings of this study are available from the corresponding author upon reasonable request.
