Dr Reddy’s Laboratories said on 2 November 2026 that the United States Food and Drug Administration has tentatively approved its lenacapavir generic, a twice-yearly injection to prevent HIV infection. The Hyderabad company is the first of six manufacturers licensed by Gilead Sciences to clear that review, according to Reuters. The decision does not allow sale in the United States yet, but it clears a path to supply in 120 low and middle income countries covered by the licensing agreements.
The medicine is a long-acting injectable form of pre-exposure prophylaxis, known as PrEP. A person at risk would receive it twice a year, rather than taking a daily tablet. Gilead developed the original medicine, approved in the United States earlier in 2026 under the brand name Yeztugo. Reuters reported that the original was nearly 100 percent effective in large trials.
For health programmes in poorer countries, the price gap is the central point. The lenacapavir generic is expected to cost about 40 dollars per person per year, according to global health agencies cited by Reuters. The branded medicine carries a list price of about 28,000 dollars per year in the United States. That gap explains why the lenacapavir generic matters for access.
Dr Reddy’s said initial supplies are expected to reach a few low-income countries before the end of 2026, with a broader rollout in 2027. The company worked with Unitaid, the Clinton Health Access Initiative and the Wits Reproductive Health and HIV Institute on the project. Unitaid is a global health agency hosted by the World Health Organization.
Lenacapavir generic approval and what tentative means
Tentative approval is a specific FDA category. It means the application met the agency’s standards for safety, efficacy and quality, but the product cannot yet be sold in the United States because of patent or exclusivity issues. That distinction matters because the lenacapavir generic can still move toward supply in the licensed countries while the United States market remains closed.
Gilead granted voluntary licences to six generic manufacturers, and the agreements are nonexclusive and royalty free for the 120 countries named in them. Dr Reddy’s is the first of the six to receive tentative FDA approval. The other five had not received that approval at the time of the announcement, according to reporting on 2 November.
Lenacapavir generic price and supply plan
The supply plan runs in two phases. The first phase, before the end of 2026, covers a limited number of countries. The second phase, through 2027, covers a wider rollout across sub-Saharan Africa, Asia and Latin America, the regions named in the licensing agreements. Dr Reddy’s did not publish a country by country schedule for the lenacapavir generic in the announcement.
Cost was set through an agreement with Unitaid, the Clinton Health Access Initiative and Wits Reproductive Health and HIV Institute, which provided technical and financial support. Their involvement explains the structure of the deal, in which the lenacapavir generic is priced for public programmes in low and middle income countries rather than priced by reference to the United States market.
Indian drugmaker Hetero is working separately with the Gates Foundation on lenacapavir, according to Reuters. That work is separate from the Dr Reddy’s approval, although only Dr Reddy’s had received tentative FDA approval at that point.
How the injection works in prevention programmes
Lenacapavir works by blocking the HIV capsid, the shell that protects the virus’s genetic material. That mechanism differs from daily oral PrEP, which uses antiretroviral tablets taken each day. A twice-yearly injection removes the need for daily adherence, which has been a practical barrier for many people at risk who do not take a daily tablet consistently.
The World Health Organization updated its guidance on 14 July 2025 to recommend twice-yearly injectable lenacapavir as an added prevention choice within comprehensive HIV programmes. That guidance predates the generic approval, and it applies to the medicine in general rather than to one manufacturer’s version. Programmes that adopt the lenacapavir generic will still need to fit it into existing testing, counselling and follow-up services.
What happens next in India and elsewhere
For India, the approval does not by itself make the medicine available in clinics. Domestic marketing would still need clearance from the Central Drugs Standard Control Organisation, patent clearance and inclusion in National AIDS Control Organisation programme guidance, according to reporting on the announcement. India has the world’s third largest population of people living with HIV, which makes domestic access separate from export supply.
For the licensed countries, the next steps are procurement and delivery. Agencies must place orders and train staff to give an injection that lasts for months. Those steps take time, which is why first supplies of the lenacapavir generic are described as reaching only a few countries in 2026, with wider supply following in 2027.