Dollars and dilemmas: lenacapavir’s pricing, patents, and the path to affordability

Abstract

Lenacapavir (Yeztugo), the world’s first twice-yearly human immunodeficiency virus (HIV) prevention injection, offers transformative potential but faces a critical challenge: affordability. While its production cost is estimated at just $25 per person annually, projections place its market price at over $25,000 in high-income settings, a 1000-fold markup that could restrict access in low- and middle-income countries (LMICs). Gilead’s licensing agreements with six generic manufacturers, covering 120 low-income countries, mark a step forward. However, upper middle-income countries with significant HIV burdens remain excluded. Four of these excluded countries namely Argentina, Brazil, Mexico, and Peru that hosted the pivotal PURPOSE-2 trial, due to ongoing high HIV transmission among sexual and gender minorities (SGM) and their historical underrepresentation in HIV clinical trials. This raises serious concerns about post-trial access. Moreover, the licensing terms limit flexibility, restrict generic sales outside designated territories, and omit price caps. Without broader coverage or concrete affordability commitments, millions may be left behind. Patent filings and the absence of a Medicines Patent Pool (MPP) partnership also amplify structural barriers. To meet global HIV targets, lenacapavir’s rollout must be guided by equity, not monopoly. The coming year will be decisive and will determine whether this breakthrough becomes a global game-changer or another symbol of structural health inequity.

Introduction

Human immunodeficiency virus (HIV) remains a significant public health threat, affecting millions and causing hundreds of deaths annually [1]. As lenacapavir, branded as Yeztugo for pre-exposure prophylaxis (PrEP), gains approval as the world’s first twice-yearly HIV prevention shot, an equally critical issue is unfolding outside the clinic, the battle over pricing and intellectual property. Will this groundbreaking medicine be accessible to the millions who need it, or will it be priced out of reach, repeating past inequities in HIV care? Early estimates suggest the manufacturer might set Yeztugo’s price at around $25,000 per person per year in wealthy markets, despite reports that mass production could cost as little as $25 annually [2]. This thousand-fold markup reveals the dilemmas of profit versus public health. The article explores the pricing mechanisms, patent landscape, and licensing arrangements shaping lenacapavir’s global rollout and what they mean for equitable access.

Sticker shock vs. production cost: the pricing puzzle

The therapeutic value of lenacapavir is undeniable, a shot every 6 months that virtually eliminates HIV acquisition risk is a potential “pandemic-ending” innovation [3]. However, life-saving HIV drugs often launch at exorbitant prices. The manufacturer has not yet publicly announced the US price for Yeztugo as of mid-2025, but reports have shown it is likely to be on par with current preventive medications at about $25,000 a year [2]. For context, ViiV’s long-acting cabotegravir PrEP shot costs over $22,000 per year in the U.S. Moreover, lenacapavir is already approved as an HIV treatment (Sunlenca) with a hefty price tag of $39,000 annually in the U.S [2]. These figures have set off alarms in the global health community. In contrast, reports have demonstrated that lenacapavir could be produced and sold at ultra-low cost if generic manufacturing were scaled up. Some reports estimated a generic price of about $40 per person-year, and updated analysis now shows $25 per year is achievable given economies of scale (5–10 million doses/year) [2]. This calculation even includes a modest profit margin. The chasm between a potential $25,000 list price and a $25 production cost is staggering, a 1000-fold difference. Also, charging an astronomical markup “would be abhorrent” and makes it difficult to end acquired immunodeficiency syndrome (AIDS) with medicines that are so costly. Nonetheless, high-income countries would also struggle to fund broad PrEP coverage at over $20,000 annual cost per person, let alone in low-resource settings. The clear message is that the price of lenacapavir must be driven down dramatically to fulfill its public health promise, and making lenacapavir unaffordable in epidemic countries will only perpetuate HIV transmission.

Manufacturer licensing gambit: 120 countries, generics, and gaps

Faced with mounting pressure, the manufacturer has taken a page from the HIV playbook by pursuing voluntary licensing to enable generic access in poorer countries. In October 2024, the manufacturer announced royalty-free licensing agreements with six generic companies: Dr. Reddy’s Laboratories Limited (India), Emcure Pharmaceuticals (India), Eva Pharma (Egypt), Ferozsons Laboratories Limited (Pakistan), Hetero Labs (India), and Mylan (United Kingdom), to supply 120 countries, primarily low- and lower-middle-income nations. Gilead’s pivotal PURPOSE-2 efficacy trial was deliberately located in four Middle-Income Countries (MICs) namely Argentina, Brazil, Mexico and Peru, because of sustained HIV transmission trends identified among sexual and gender minorities (SGM) with annualised incidence of 2.62% in Brazil and 6.69% in Peru and a history of underrepresentation in HIV research [3, 4]. Yet the company’s voluntary-licence package contains an anti-diversion clause that expressly forbids its 120 sublicensees from selling lenacapavir to those very same countries. This creates what ethicists describe as “post-trial access failure” where a sponsor leverages high-incidence MICs to generate efficacy data, then withholds affordable supply once regulatory filings are imminent, effectively externalising research benefits to high-income markets while shifting epidemic risk back onto SGM communities in the trial countries [5]. Facing such an “extractive” posture, civil-society groups in Latin America have already signalled their intent to pursue compulsory-licence pathways unless the manufacturer extends coverage or removes the anti-diversion language. Under this arrangement, these partners can produce generic lenacapavir for PrEP once they receive regulatory approval [6]. Also, the manufacturer pledged to provide its branded lenacapavir at no profit to these countries until the generics become available [6].

This two-pronged strategy, that is, immediate cost-limited supply by the manufacturer, followed by cheaper generics, is intended to facilitate broad, sustainable access in resource-limited settings [6]. This is a significant step. The licensing deal was reached “in advance of any global regulatory submissions” to avoid delay [6], indicating the manufacturer’s recognition of global expectations. Also, the country list (120 nations) mirrors those covered in prior HIV licenses (e.g., for antiretrovirals), which are the highest-burden, lowest-income regions in Sub-Saharan Africa (SSA) and parts of Asia. If executed properly, the deal could help achieve the goal set by the U.S. President's Emergency Plan for AIDS Relief (PEPFAR) and the Global Fund to put 2 million people on lenacapavir PrEP in the coming years [7]. However, the devil is in the details, and there are several drawbacks in the current licensing framework. First, the country coverage, while large, excludes many upper middle-income countries that also have substantial HIV epidemics [8]. For example, Brazil, Mexico, Russia, China, Thailand, and several Latin American nations are left out of the manufacturer’s 120-country list. These exclusions collectively account for a significant share of global HIV infections (e.g., 12 excluded Latin American countries represent 7% of people living with HIV worldwide). These countries may be expected to pay full price for Yeztugo or negotiate separately, a prospect that could delay or limit access. Most of the excluded countries are those where patent challenges or compulsory license threats exist (e.g., Brazil, Thailand, India). By including some countries with pending patent oppositions (like Vietnam, South Africa) and excluding others like Peru or Brazil, the manufacturer may be leveraging licenses to dissuade patent challenges [8]. Similarly, no pharmaceutical company from SSA was included in the royalty-free licensing agreements, despite the region having the highest prevalence of HIV/AIDS and PURPOSE-1 being conducted in South Africa and Uganda [9, 10]. These countries will still need to import the drug, missing a crucial opportunity to strengthen Africa’s growing pharmaceutical industry, including modular manufacturing initiatives and the Partnership for African Vaccine Manufacturing.

Second, the licenses impose strict controls. The agreement gives the manufacturer significant oversight over the supply of the active ingredient and requires licensees to source materials through manufacturer-approved channels. It also restricts the sale of generics outside the licensed territories, even in the event a country issues a compulsory license, generics still cannot easily supply them due to contractual terms. These clauses could constitute a “step backward” from earlier licenses and an affront to the rights that countries have under Trade-Related Aspects of Intellectual Property Rights (TRIPS) to procure affordable medicines when needed. By comparison, Medicines Patent Pool (MPP) licenses usually allow more flexibility and autonomy for generic producers. And what about pricing under the license? Conspicuously, nowhere in the public licensing terms are concrete price ceilings or affordability requirements set [8]. The company has only mentioned it would ensure prices that allow broad availability, but as of mid-2025, no actual price per dose has been revealed for low-income countries [8]. During the interim period, while only Gilead’s product is available, this is especially concerning – it leaves uncertainty whether lenacapavir will be provided at a truly affordable price or just a modest discount. Without an upfront “price-volume commitment” by the manufacturer and donors, there is a risk of insufficient volume or high cost undermining early rollout. Many stakeholders are coalescing around a target price of roughly $100 per person-year or less as a benchmark for long-acting PrEP to be cost-effective and scalable in low- and middle-income countries (LMICs) [8]. Reaching such a price will likely require high-volume orders (hence donor guarantees) and efficient generic competition as soon as possible.

Patent landscape and the role of the MPP

Lenacapavir’s patent estate will also influence access. The manufacturer has filed multiple patents on lenacapavir and related compounds, which could extend its market exclusivity. According to the Medicines Patent Pool’s tracker, international patent applications on lenacapavir prodrugs were filed in late 2022 [11]. If granted, these could pose barriers to generic entry in countries not covered by the voluntary license or after the license period. So far, lenacapavir is not included in any MPP-brokered license, given the direct negotiation with manufacturers. Partnership with MPP for a comprehensive license that extends to additional countries and with better terms would be game-changing [6, 11]. The MPP has a transparent model that emphasizes affordability. For instance, a recent MPP agreement for an HIV drug with Spain’s CSIC included a clause mandating sublicensees use “commercially reasonable efforts” to make the product available in LMICs at affordable pricing [8]. No such language appears in lenacapavir licenses. Without MPP involvement, it falls on advocacy and goodwill to ensure prices are drastically reduced.

MICs left out may resort to compulsory licensing or local production to get lenacapavir at cheap prices. For instance, in 2023, Colombia issued a compulsory license for dolutegravir when facing a $1,200 per patient yearly price, since it was excluded from a voluntary license [8]. Lenacapavir could trigger similar actions if the manufacturer does not extend access. Some countries, like Thailand, India, South Africa, and Vietnam, have already lodged patent oppositions seeking to prevent overly broad patents [4]. Interestingly, all those countries were included in the manufacturer’s license, although this has been criticised as a tactic to temper those legal challenges [8].

It’s worth noting that the manufacturer’s past track record on HIV medicine access is mixed. On one hand, the company’s partnerships with generics in the past have enabled over 30 million patient courses of HIV and hepatitis treatments in developing countries [6]. On the other hand, it has faced criticism for high prices on drugs like tenofovir alafenamide (TAF) and not immediately licensing newer products to MPP (e.g., bictegravir). With lenacapavir, the manufacturer’s initial moves demonstrate awareness of access concerns, but whether it does the right thing remains under scrutiny. As lenacapavir enters the market, several developments in the coming year will determine its affordability for countries most in need, and these have been highlighted in Fig. 1 below.

Fig. 1.

Toward equitable access: The next 12 months – key determinants of lenacapavir affordability and rollout

Conclusion

The promise of lenacapavir will only be realized if the monopoly of the drug is managed in the public interest. The next phases of licensing and pricing negotiations will determine whether this prevention tool is confined to the rich and a handful of donor-funded programs or whether it can reach the millions at risk in SSA, Asia, and the Americas. The stakes are extremely high. Modelling study suggests that making lenacapavir widely available at low cost could “turn off the tap” of new infections in many settings [12]. Conversely, if it remains a $20,000 per-year luxury, it will scarcely dent the HIV epidemic. As we strive for the 2030 goal to end AIDS, the world has learned that scientific breakthroughs must be matched by breakthroughs in access. The case of lenacapavir is a defining test of that principle. The global health community, from UN leaders to generic drugmakers to activists, is uniting to ensure this “100% effective” injection does not become 100% inaccessible. The manufacturer, for its part, has an opportunity to set a new gold standard for equitable licensing and pricing. The coming year will reveal whether profit or public good wins out in this balance. If global pressure succeeds, lenacapavir could herald both a medical and access revolution, proving that we can indeed deliver “medicines for all who need them” in the fight to end HIV.

Abbreviations

HIV

Human Immunodeficiency Virus

PrEP

Pre–Exposure Prophylaxis

US

United States

PEPFAR

President’s Emergency Plan for AIDS Relief

TRIPS

Trade–Related Aspects of Intellectual Property Rights

MPP

Medicines Patent Pool

LMICs

Low–and Middle–Income Countries

MICs

Middle–Income Countries

CSIC

Consejo Superior de Investigaciones Científicas (Spanish National Research Council)

TAF

Tenofovir Alafenamide

SSA

Sub–Saharan Africa

SGM

Sexual and Gender Minorities

Authors’ contributions

Conceptualization: VAA; Writing-original draft: VAA and AA; Writing-review and editing: VAA and AA.

Funding

None.

Data availability

No datasets were generated or analysed during the current study.

Declarations

Ethics approval and consent to participate

Not applicable.

Competing interests

The authors declare no competing interests.