The US Food and Drug Administration has granted tentative approval to the first generic version of injectable lenacapavir, a twice-yearly shot that prevents HIV. Made by Dr. Reddy’s Laboratories, the generic will cost US$40 per person per year and is intended for the 120 low- and middle-income countries covered by Gilead’s voluntary licence, Unitaid announced on 2 November 2026.
Key facts
- What it is: lenacapavir, a long-acting injectable for HIV pre-exposure prophylaxis (PrEP), given twice a year
- Approval type: FDA tentative approval, standard for generics while the original remains under patent
- Timeline: about 16 months after Gilead’s original product was approved for HIV prevention in June 2025
- Supply: first supplies expected by the end of 2026, with wider availability in 2027
- Partners: Unitaid, Wits RHI and the Clinton Health Access Initiative supported development; the Gates Foundation is working on access and introduction
- Demand: more than 125,000 people in 10 early-adopter African countries have already started Gilead’s lenacapavir
Why it matters
Daily PrEP pills work, but many people struggle to take them every day. Two injections a year remove that burden. A price of US$40 a year could make long-acting prevention affordable for national programmes. As Wits RHI’s Saiqa Mullick put it, an affordable drug alone is not enough: health systems, confident providers and engaged communities are also needed.
What it means for nurses
- Nurses will deliver most injections and counselling in PrEP programmes
- HIV testing must be negative before starting and repeated at follow-up
- Missed injection visits need follow-up to avoid gaps in protection
- Counselling should cover that PrEP does not prevent other STIs or pregnancy
Frequently asked questions
Is lenacapavir a vaccine?
No. It is an antiretroviral medicine given as prevention, not a vaccine.
Will it be available in high-income countries at $40?
The generic price applies to the 120 licensed low- and middle-income countries. Prices elsewhere differ.
Related reading: HIV PrEP and PEP guide · Early signs of HIV
Source: Unitaid.