Published: June 27, 2026
Introduction
There is a revolution happening in HIV prevention. A new injectable drug called lenacapavir (branded as Sunlenca by Gilead Sciences) can prevent HIV infection with just two injections per year. Clinical trials have shown it to be over 96% effective, with some studies reporting zero infections among participants.
This is a game-changer, especially for a country like South Africa, which has the highest number of new HIV infections in the world. But there is a problem: the drug is expensive, and South Africa cannot manufacture it locally—yet.
This blog post unpacks everything you need to know: what lenacapavir is, how much it costs, who is manufacturing generics, why Gilead has not granted licenses to South African companies, and what the future holds.
What is Lenacapavir?
Lenacapavir is a long-acting antiretroviral drug developed by the American pharmaceutical giant Gilead Sciences. It is used as Pre-Exposure Prophylaxis (PrEP) , meaning it prevents HIV-negative people from contracting the virus.
Key facts:
- Dosage: Two subcutaneous injections per year (every 6 months).
- Effectiveness: Reduces HIV risk by 96% to over 99.9%.
- Target population: Adults and adolescents weighing at least 35 kg who are HIV-negative and at risk of infection.
- Status: Approved for use in South Africa and recommended by the World Health Organization (WHO).
Unlike daily oral PrEP pills, which require strict adherence, lenacapavir offers a “set it and forget it” approach that is far more convenient and discreet. This makes it ideal for young women, sex workers, and other high-risk populations who may struggle with daily pill-taking.
The Price Problem: From $28,000 to $40
Lenacapavir was developed in the United States, and the branded version comes with a staggering price tag: approximately $28,000 per year in the US market.
However, in October 2024, Gilead signed voluntary licensing agreements with six generic manufacturers in India, Pakistan, and Egypt to produce a cheaper version for 120 low- and middle-income countries. The target price for these generics is $40 (about R692) per person per year.
That breaks down to:
- $20 (R346) per injection
- $40 (R692) for both injections in a year
- An extra one-off “loading dose” of about $17 (R270) to kickstart the protection
This is a monumental price reduction—from $28,000 to $40—making the drug potentially accessible to millions who need it most.
The South African Situation: A Country Excluded
South Africa is classified as an upper-middle-income country. Because of this classification, Gilead’s licensing deal initially excluded South Africa from accessing the $40 generic price. This is despite South Africa having the highest burden of HIV in the world, with over 7.7 million people living with the virus.
This sparked significant anger and backlash from civil society groups like Médecins Sans Frontières (MSF) , who accused Gilead of “pharmaceutical exploitation” and of using African populations for clinical trials while denying them the right to manufacture the resulting medicines.
The Push for Local Manufacturing
The South African government, through the South African National AIDS Council (SANAC) , has been actively pushing for a license to produce generic lenacapavir locally.
- March 2026: SANAC published an open call for local pharmaceutical companies to apply for the chance to manufacture generic lenacapavir.
- April 7, 2026: The application deadline closed.
- By July 2026: SANAC will submit a shortlist of capable South African manufacturers to Gilead for final approval.
Who Has Applied?
The official list of applicants has not been made public, but the following companies have publicly expressed interest or are known to be involved:
| Company | Type |
|---|---|
| Aspen Pharmacare | South Africa’s largest pharmaceutical company |
| Pharmacare | South African manufacturer |
| Cipla Medpro | South African arm of Indian generic giant Cipla |
| Kiara Health | South African pharmaceutical company |
| Adcock Ingram | Major South African drug manufacturer |
| Pharma Q | South African manufacturer |
None of these companies currently hold a license from Gilead to produce lenacapavir. The decision ultimately rests with Gilead.
Why Won’t Gilead Grant Licenses to South African Companies?
This is the million-dollar question. On the surface, it seems counterintuitive for a company to refuse to license a life-saving drug that could help millions. But the reality is more complex.
Reason 1: Technical Specifications (The Official Reason)
Gilead’s stated reason is that the South African companies evaluated in 2024 did not meet the technical specifications for the production of sterile injectables. Lenacapavir is a sterile, preservative-free injectable that is also sensitive to light. Producing it requires:
- End-to-end manufacturing capability: Synthesizing the Active Pharmaceutical Ingredient (API) in-house.
- Aseptic processing: Sterile filling and packaging under rigorous conditions.
- Vertically integrated facilities: A single company that can handle all steps from API synthesis to final packaging.
Gilead claims that the South African companies could not demonstrate this level of capability at the time.
Reason 2: Strategic Control (The Real Reason?)
Many critics argue that the “technical” excuse is a smokescreen. The real reason is corporate control and profit.
- Market Protection: By carefully choosing who gets a license and where they can sell, Gilead protects its profitable markets in the US and Europe, where the drug sells for $28,000 per year.
- Preventing “Leakage”: Gilead wants to prevent generic versions manufactured in countries like South Africa from being exported back into wealthy markets.
- Managing the Timeline: By controlling the entry of generics, Gilead ensures its branded version dominates the market until at least 2027.
Reason 3: Excluding Middle-Income Countries
Gilead’s licensing strategy excludes 26 middle-income countries from accessing affordable generics. South Africa, classified as an upper-middle-income country, falls into this excluded category—even though it has the highest number of new HIV infections globally.
The Official Response from South Africa
South African officials have pushed back forcefully.
- Health Minister Dr. Aaron Motsoaledi: Has personally communicated with Gilead, stating that South Africa “deserves a licence.” He has announced that Gilead has indicated a willingness to grant a license to a capable South African company.
- Deputy President Paul Mashatile: As Chairperson of SANAC, he has publicly committed to securing local production.
The government is not backing down. There is even talk of issuing a compulsory license—a legal mechanism that allows a government to produce a patented drug without the patent holder’s consent in a public health emergency.
Who Is Driving the Negotiations?
The negotiations are a multi-layered effort involving several key players:
| Organization / Person | Role |
|---|---|
| SANAC | Leading the effort; chaired by Deputy President Paul Mashatile |
| Thembisile Xulu | CEO of SANAC; responsible for the shortlist process |
| Dr. Aaron Motsoaledi | Health Minister; the public face of the negotiations |
| Department of Health | Provides regulatory and policy support |
| Department of Trade, Industry and Competition | Supports local industrial development |
| Unitaid & MedSuRe Africa | Provide technical and advisory support |
| Gilead Sciences | The patent holder; holds the final decision-making power |
| Wendy Cupido | Country Manager for Gilead in South Africa |
The process is coordinated, but the ultimate decision rests with Gilead.
What About Buying Generics from India?
Yes, South Africa can buy generic lenacapavir from India—but not yet.
- Licensed Indian manufacturers: Hetero Labs, Dr. Reddy’s, and others.
- Availability: Expected in 2027.
- Price: $40 per year.
- Supply: May not meet full domestic demand, especially for a country the size of South Africa.
Indian generics are a near-term solution, but long-term security requires local manufacturing.
What Is the Timeline?
| Event | Date / Status |
|---|---|
| Gilead grants licenses to Indian generic manufacturers | October 2024 |
| SANAC issues Expression of Interest for local manufacturers | March 2026 |
| Application deadline for South African companies | April 7, 2026 |
| SANAC shortlist submitted to Gilead | Expected by July 2026 |
| Gilead decision on South African license | Unknown / No public deadline |
| Indian generics available in South Africa | Expected 2027 |
| Local South African production (if licensed) | Target 2027 |
Conclusion: Hope, Frustration, and the Battle for Access
Lenacapavir is a scientific breakthrough that has the potential to change the course of the HIV epidemic in South Africa. But access is not guaranteed.
The price drop from $28,000 to $40 shows that affordability is possible. However, the exclusion of South Africa from the initial licensing deal, and the resistance to granting local manufacturing licenses, highlights the ongoing tension between public health and corporate profit.
South Africa is fighting back—through SANAC, through the Health Minister, and through negotiations with Gilead. Whether those negotiations succeed, or whether the government will resort to a compulsory license, remains to be seen.
One thing is clear: the fight for access to this life-saving drug is far from over. For millions of South Africans at risk of HIV, the stakes could not be higher.
Disclaimer: This blog post is for informational purposes only and does not constitute medical advice. Please consult a healthcare professional for personal health decisions.