NEW DELHI: HL November 03, 2026
In a significant development in the global fight against HIV, the US Food and Drug Administration (FDA) has approved an Indian-developed generic version of lenacapavir, an injectable medicine designed to prevent HIV infection. The development is expected to improve access to long-acting HIV prevention in 120 low- and middle-income countries through more affordable pricing.
Developed by India’s Dr. Reddy’s Laboratories, the generic formulation offers an alternative to conventional daily HIV prevention pills. One of its major advantages is its long-acting nature, as it requires administration only twice a year, potentially making HIV prevention more convenient for people at risk of infection.
According to the reported pricing arrangement, the medicine is expected to be available at approximately $40 (around ₹3,790) per person annually. This could make long-acting HIV prevention more accessible in countries where the cost and availability of preventive healthcare remain significant challenges.
The development was supported by collaborations involving the United, the Clinton Health Access Initiative (CHAI) and the Wits Reproductive Health and HIV Institute (Wits RHI) in South Africa. These partnerships played an important role in accelerating the development and potential availability of affordable generic versions.
The original drug manufacturer, Gilead Sciences, has also entered into royalty-free licensing agreements with multiple generic manufacturers to facilitate production and expand access across eligible countries.
Why Is Lenacapavir Important for HIV Prevention?
Unlike conventional pre-exposure prophylaxis (PrEP), which generally requires daily medication, lenacapavir offers a long-acting preventive option administered twice yearly. This less frequent dosing schedule may improve convenience and help address challenges associated with daily pill adherence.
Clinical studies involving people at substantial risk of HIV infection have demonstrated highly encouraging results, with the injectable medicine showing near-complete protection against new infections in the studied populations.
Experts believe that expanding access to affordable long-acting preventive medicines could strengthen global HIV prevention programmes and contribute to reducing new infections.
Global HIV Burden Highlights Need for Affordable Prevention
According to the World Health Organization (WHO), approximately 41 million people were living with HIV worldwide in 2025. The continued global burden highlights the importance of expanding access to effective prevention, early diagnosis and treatment services.
The availability of affordable generic lenacapavir could represent an important step towards making advanced HIV prevention technologies more accessible, particularly in resource-limited countries.
However, its public health impact will depend on regulatory access, supply, affordability and integration into national HIV prevention programmes.
