India’s Dr Reddy’s gets US nod for $40 generic HIV prevention shot for 120 poorer countries

An Indian pharmaceutical company’s low-cost version of a breakthrough HIV prevention drug has received tentative approval from the US Food and Drug Administration (FDA), bringing affordable protection against the virus closer to millions of people in developing countries.

Dr. Reddy’s Laboratories announced on Monday that its generic version of lenacapavir, an injectable drug administered twice a year, had received the US regulator’s approval.

The development is expected to make the drug available at $40 per person annually across 120 countries, under a pricing agreement aimed at expanding access in low- and middle-income nations.

According to an AFP report, the original drug was developed by US pharmaceutical company Gilead Sciences and received approval in June 2025 after clinical trials showed that it was more than 99.9 per cent effective in preventing HIV infection.

The approval marks an important step towards making one of the most promising HIV prevention treatments accessible beyond wealthy countries, where its high price has so far limited its reach.

India-made generic to cost $40 per person annually

The $40 annual price was agreed upon in September 2025 through an arrangement involving Unitaid, South Africa’s Wits RHI, the Clinton Health Access Initiative (CHAI) and Dr. Reddy’s Laboratories.

The Indian company’s generic version has received tentative approval through an accelerated FDA pathway that allows manufacturers to rely on existing clinical data.

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The original lenacapavir treatment costs around $28,000 annually in the United States, although insurance coverage can reduce the amount paid by patients.

Gilead granted voluntary licences to six generic drug manufacturers, including Dr. Reddy’s, in late 2024 to help expand access to the treatment in developing countries.

Unitaid said more than 125,000 people across 10 early-adopter African countries had already started using Gilead’s version of the drug, even before generic alternatives became available.

Twice-yearly injection offers alternative to daily pills

Lenacapavir is a long-acting injectable drug used as pre-exposure prophylaxis (PrEP), a preventive treatment for people at risk of contracting HIV.

Unlike conventional prevention pills, which need to be taken daily, lenacapavir requires just two injections a year.

Although it works differently from a vaccine and does not train the immune system, its long-lasting protection could make HIV prevention easier for people who struggle to take daily medication consistently.

The drug was named ‘Breakthrough of the Year’ in 2024 by the scientific journal Science for its research into the HIV capsid protein, the protective shell surrounding the virus’s genetic material. Lenacapavir targets this protein.

Earlier prevention options included daily oral PrEP pills, approved in 2012, and cabotegravir injections, which require administration every two months.

Global rollout remains the next challenge

Unitaid said the FDA decision was a major step towards reducing the gap between the availability of breakthrough medicines in wealthy countries and their access in poorer regions.

However, making the drug available at an affordable price is only the beginning. Governments, healthcare systems and local organisations will now need to work together to ensure that the injections reach communities that need them.

Around 1.2 million people acquired HIV last year, highlighting the continuing need for effective prevention measures.

The HIV epidemic has claimed more than 40 million lives over the past four decades. Although advances in antiretroviral treatment have made it possible for people living with HIV to manage the infection and lead longer lives, preventing new infections remains a major public health priority.