Dr. Reddy’s secures a regulatory milestone for the twice-yearly HIV prevention injection, with initial supplies expected by the end of 2026.
Generic lenacapavir has secured tentative approval from the United States Food and Drug Administration, advancing plans for wider HIV prevention access. Dr. Reddy’s Laboratories developed the first generic version of the twice-yearly injection.
The milestone could help expand access across 120 low- and middle-income countries. Initial supplies are expected to reach countries by the end of 2026, with national regulatory approvals among the remaining steps.
The decision comes just 16 months after approval of Gilead Sciences’ original product. Meanwhile, partners supporting the rollout say more than 125,000 people across 10 early-adopter African countries have started using Gilead’s lenacapavir.
Generic lenacapavir targets lower-cost prevention
The partners expect pricing in line with oral pre-exposure prophylaxis, commonly known as PrEP. CHAI chief executive Dr. Neil Buddy Shah put the projected price at $40 per year.
The injection could therefore offer another option for people who find daily preventive pills difficult to maintain. Shah said two injections annually could transform access to prevention, describing the product as almost 100% effective against HIV.
A September 2025 agreement between Unitaid, Wits RHI, the Clinton Health Access Initiative and Dr. Reddy’s underpins the development. It combined an early pricing commitment with financial, technical and regulatory support to speed market entry.
Unitaid executive director Dr. Philippe Duneton said early investment and partnerships had helped shorten the path from scientific advances to access. He also highlighted the potential benefits for young women in Africa, including faster access and fewer infections.
Countries must prepare for introduction
However, the partners warned that regulatory progress and lower prices would not alone ensure widespread access. Wits RHI’s implementation science director, Professor Saiqa Mullick, said countries need ready health systems, trained providers and community involvement.
Those delivery arrangements would help the injection reach underserved populations fairly, she said. The partners are also working with governments, communities and international organisations to support introduction, community engagement and evidence generation.
These organisations include the Global Fund, the Gates Foundation and the US Bureau of Global Health Security and Diplomacy. Meanwhile, Dr. Reddy’s said affordable production required substantial scientific and manufacturing expertise.
The development builds on voluntary licences Gilead granted to six generic manufacturers in late 2024, including Dr. Reddy’s. The company combined lenacapavir’s prevention and treatment indications in one application through the FDA’s 505(b)(2) pathway. That approach secured priority review and helped shorten the approval timeline.
