The United States Food and Drug Administration (FDA) has granted tentative approval to a cheaper generic version of a twice-yearly HIV prevention injection, paving the way for wider access to the drug in 120 low- and middle-income countries.
The generic version of lenacapavir, developed by Indian pharmaceutical company Dr. Reddy’s Laboratories, is expected to cost $40 per person annually under a pricing agreement involving global health organisations.
The announcement was made on Monday, November 2, 2026, by Dr. Reddy’s and Unitaid, a global health initiative.
The development could significantly improve access to HIV prevention, particularly in countries where the high cost of existing treatments has limited availability.
Under the agreement announced in September 2025, the generic injection will be supplied at $40 per person per year across 120 eligible countries.
The partnership involves Dr. Reddy’s Laboratories, Unitaid, the Wits Reproductive Health and HIV Institute (Wits RHI) and the Clinton Health Access Initiative (CHAI).
Lenacapavir was originally developed by US pharmaceutical company Gilead Sciences and received FDA approval for HIV prevention in June 2025 after demonstrating more than 99.9 per cent effectiveness in large clinical trials.
Unlike traditional pre-exposure prophylaxis (PrEP) pills, which must be taken daily, lenacapavir is administered through an injection twice a year.
The long-acting treatment offers an alternative for people who may find it difficult to maintain a daily medication routine.
However, the high price of the original drug has remained a major obstacle to widespread access. Its annual list price in the United States is approximately $28,000.
In late 2024, Gilead granted voluntary licences to six generic manufacturers, including Dr. Reddy’s, to produce more affordable versions for eligible countries.
Dr. Reddy’s Chief Executive Officer of Pharmaceutical Services and API, Deepak Sapra, described the latest development as a significant achievement.
“This is a moment of immense pride for all of us at Dr. Reddy’s,” Sapra said.
He explained that developing and manufacturing an affordable, long-acting injectable required significant scientific capabilities and manufacturing expertise.
Unitaid Executive Director Philippe Duneton also said the partnership was helping shorten the time between scientific breakthroughs and access to essential medicines.
According to Unitaid, more than 125,000 people across 10 early-adopter African countries had already started using Gilead’s lenacapavir before the generic version became available.
The FDA’s tentative approval is expected to accelerate access to the generic drug in eligible countries, although national regulatory processes and funding will remain important for its rollout.
The approval does not mean the generic version can be sold in the United States, where Gilead’s branded product remains protected by patent restrictions.
The development marks an important step towards making long-acting HIV prevention more affordable, particularly for populations in low- and middle-income countries.
