The FDA has officially approved the marketing of a generic version of lenacapavir, an injectable drug that offers six months of protection against HIV infection. Indian manufacturer Dr. Reddy's Laboratories has committed to a price of just $40 per person per year. The original lenacapavir was developed by Gilead and approved for pre-exposure prophylaxis in June 2025, with the branded version costing approximately $28,000 per year. Gilead previously agreed to supply the drug to the Global Fund at a non-profit price of $120 per person per year and licensed six generic manufacturers to produce it for 120 low- and middle-income countries. Dr. Reddy's is the first generic manufacturer to receive FDA approval. Through negotiations facilitated by the Clinton Health Access Initiative, Dr. Reddy's plans to deliver the product to relevant countries by the end of the year. The generic price is comparable to the current annual per-capita cost of oral pre-exposure prophylaxis in South Africa and will benefit young women in South Africa and neighboring regions, where new infection rates are the highest in the world. Lenacapavir has previously seen slow rollout, with only a small number of people accessing it through the Global Fund; the generic version is expected to resolve supply challenges. Combined with the fact that FDA approval typically accelerates national regulatory review processes, this highly effective prevention drug is expected to reach low-income countries with high infection rates more quickly. CHAI has set a goal of 20 million people globally using lenacapavir by 2030, including 9 million in Africa, and the per-capita annual price is expected to fall further below $40 as other generic manufacturers enter the market.