A generic version of lenacapavir, a long-acting HIV prevention injection, has received tentative approval from the United States Food and Drug Administration (FDA). The development could make generic lenacapavir available at about $40 per person annually in 120 low- and middle-income countries.
The medication is administered twice a year and offers an alternative to daily oral pre-exposure prophylaxis (PrEP), which helps people at risk of HIV infection prevent the virus before exposure.
The announcement came on Monday, November 2, from Indian pharmaceutical company Dr. Reddy’s Laboratories and organisations supporting the generic drug’s development.
Under an existing pricing agreement, the injection will cost approximately $40 per person per year in the eligible countries. This puts its expected annual price on par with existing daily HIV prevention pills.
How the Generic HIV Prevention Injection Works
Lenacapavir is a long-acting medicine that provides HIV prevention through injections given every six months.
Unlike daily PrEP tablets, users do not need to remember to take a pill every day. Health advocates say this could help people who struggle with consistent medication use maintain protection against HIV.
Carmen Pérez Casas, HIV lead at global health agency Unitaid, said daily prevention medication only works when people take it consistently.
She explained that missed doses can leave people without the protection they need. The longer interval between lenacapavir injections could therefore help address one of the challenges facing existing prevention options.
The drug has also shown very high effectiveness in two major clinical studies involving people at increased risk of HIV infection. The trials found that lenacapavir nearly eliminated new infections among participants.
Generic Lenacapavir Could Reach 120 Countries
The generic formulation was developed by Dr. Reddy’s Laboratories with financial, technical and regulatory support from Unitaid, the Clinton Health Access Initiative (CHAI) and Wits RHI.
Carolyn Amole, who leads the HIV programme at CHAI, said the affordable version could help expand access to PrEP among millions of people worldwide.
She said an affordable, high-quality generic could support efforts to reach approximately 20 million people who need HIV prevention medication.
Amole expressed hope that wider access would help reduce new infections and strengthen global efforts to end the HIV epidemic.
The FDA’s decision is a tentative approval. It helps move the generic product closer to supply in the 120 eligible countries, but it does not mean the medicine is immediately available everywhere.
According to the organisations involved, initial supplies are expected to reach some countries before the end of 2026, while broader availability is planned for 2027.
Global HIV Figures Highlight Need for Prevention
The development comes as HIV remains a major public health challenge.
The World Health Organisation estimates that 41 million people were living with HIV worldwide in 2025. About 570,000 people died from HIV-related illnesses during the same period.
Affordable and accessible prevention options remain important in efforts to reduce new infections and HIV-related deaths.
By combining a lower expected price with injections administered twice a year, generic lenacapavir could give more people access to a convenient HIV prevention option.
However, wider access will depend on country-level regulatory processes, procurement and the availability of supplies.