A generic version of the long-acting HIV prevention drug lenacapavir has received approval from the United States Food and Drug Administration (FDA), a development expected to improve access to the injection in low-income countries.
The approval was announced on Monday by Indian pharmaceutical company Dr. Reddy’s Laboratories, which developed the generic version, and Unitaid, a global health initiative.
Under a pricing agreement announced in September 2025, the generic injection is expected to be supplied at $40 per person annually across 120 countries.
The agreement involved Dr. Reddy’s, Unitaid, the South African health research institute Wits RHI and the Clinton Health Access Initiative (CHAI).
Reacting to the approval, Deepak Sapra, Chief Executive Officer of Pharmaceutical Services and Active Pharmaceutical Ingredients at Dr. Reddy’s, described the development as a major achievement for the company.
“This is a moment of immense pride for all of us at Dr. Reddy’s,” Sapra said.
“Developing and manufacturing a complex long-acting injectable like lenacapavir at an affordable price required strong scientific capabilities and manufacturing expertise to address an urgent access need.”
Unitaid Executive Director Philippe Duneton said the initiative’s early investment and willingness to take risks had helped accelerate access to medical breakthroughs.
“Unitaid’s early risk-taking is helping shorten the time between a scientific breakthrough and real access in countries,” Duneton said.
Lenacapavir was originally developed by US pharmaceutical company Gilead Sciences and received approval in June 2025 following clinical trials that demonstrated very high effectiveness in preventing HIV infection.
The drug is administered through an injection twice a year and is used as pre-exposure prophylaxis (PrEP), a preventive treatment for people who may be exposed to HIV.
Unlike daily oral PrEP tablets, which require consistent use, the long-acting injection offers an alternative that requires only two doses annually. However, lenacapavir does not work like a conventional vaccine because it does not train the body’s immune system to recognise and fight the virus.
Despite its effectiveness, the original drug’s high price has been a major obstacle to wider access. Its annual cost in the United States has been reported at about $28,000, although insurance coverage can reduce the amount paid by individual patients.
To expand availability, Gilead granted voluntary licences to six generic drug manufacturers, including Dr. Reddy’s, in late 2024.
Unitaid said more than 125,000 people in 10 African countries that adopted the treatment early had already started using Gilead’s version before generic supplies became available.
Dr. Reddy’s said the latest approval was granted under the US President’s Emergency Plan for AIDS Relief (PEPFAR), which supports efforts to prevent and respond to HIV/AIDS.
The development is expected to support efforts to make long-acting HIV prevention more affordable and accessible, particularly in countries where the cost of preventive medicines remains a major barrier.
