The United States has approved a low-cost generic version of a twice-yearly HIV prevention injection, potentially expanding access to the breakthrough treatment in low-income countries.

The approval by the US Food and Drug Administration (FDA) was announced on Monday by Indian pharmaceutical company Dr Reddy’s Laboratories and global health initiative Unitaid.

Generic HIV Prevention Shot to Cost $40 Annually

Under a pricing agreement announced in September 2025, the generic version of lenacapavir will cost $40 per person annually and be available in 120 countries.

The agreement involves Dr Reddy’s, Unitaid, South Africa’s Wits RHI and the Clinton Health Access Initiative (CHAI).

Dr Reddy’s executive Deepak Sapra described the approval as a moment of immense pride, highlighting the scientific and manufacturing expertise required to produce an affordable, long-acting injectable treatment.

Unitaid executive director Philippe Duneton said the organisation’s early investment was helping shorten the time between scientific breakthroughs and access in countries that need them.

Lenacapavir Offers Alternative to Daily HIV Prevention Pills

Lenacapavir was developed by US pharmaceutical company Gilead Sciences and approved in June 2025 after clinical trials demonstrated more than 99.9 per cent effectiveness, according to the report.

The twice-yearly injection offers an alternative to daily HIV pre-exposure prophylaxis (PrEP) pills, which require consistent use to provide protection.

Although lenacapavir has been described as vaccine-like because of its long-lasting preventive effect, it does not work by training the immune system.

The treatment’s high price has been a major barrier to wider access. Lenacapavir reportedly costs approximately $28,000 annually in the United States, although insurance can reduce the amount paid by patients.

In late 2024, Gilead granted voluntary licences to six generic manufacturers, including Dr Reddy’s, to produce more affordable versions of the drug.

African Countries Already Using Lenacapavir

Unitaid said more than 125,000 people in 10 early-adopter African countries had already started using Gilead’s lenacapavir before generic versions became available.

Dr Reddy’s said the FDA approval was granted under the agency’s President’s Emergency Plan for AIDS Relief (PEPFAR) programme.

The development could help expand access to HIV prevention in countries where the cost of treatment has remained a significant obstacle.