Unitaid (Dr. Reddy’s lenacapavir packs; crop).
Dr. Reddy’s Laboratories has secured tentative U.S. Food and Drug Administration approval for a generic injectable version of the HIV-prevention drug lenacapavir, Unitaid announced Monday, November 2. The partnership behind the product expects initial supplies to reach eligible countries before the end of 2026.
Under an existing agreement, the twice-yearly injection is to be available at $40 per person per year in the 120 low- and middle-income countries covered by Gilead’s voluntary license, according to Unitaid’s announcement. That is a price commitment for the licensed access markets, not an announced U.S. retail price.
The tentative approval came 16 months after approval of Gilead’s originator product for HIV prevention, Unitaid said. It brings a lower-cost version closer to use in countries where the cost of new medicines can delay access, but does not mean broad distribution has already begun.
Unitaid said broader availability is expected in 2027. It described the regulatory decision as a foundation for the remaining steps, including national approvals and the preparation of health systems to deliver the injection.
The product was developed by Dr. Reddy’s with financial, technical and regulatory support from Unitaid, the Wits Reproductive Health and HIV Institute and the Clinton Health Access Initiative. The partners agreed to the early pricing commitment in September 2025.
Approval moves access closer, but distribution comes next
Unitaid said the development program combined lenacapavir’s prevention and treatment indications in one application, allowing Dr. Reddy’s to seek priority FDA review. Gilead’s earlier voluntary licensing and the partners’ support also helped accelerate the process, the organization said.
Tentative approval is distinct from an unrestricted U.S. market launch. Unitaid described it as the FDA’s designation for generic products while the originator remains under patent and said it enables procurement by the U.S. government.
The access effort is aimed at an HIV-prevention option that does not require a daily pill. Unitaid said more than 125,000 people in 10 early-adopter African countries had already started Gilead’s lenacapavir before the generic becomes available. That figure concerns the originator medicine, not shipments of Dr. Reddy’s product.
Wits RHI’s implementation-science director, Professor Saiqa Mullick, cautioned in the announcement that an affordable drug alone is not enough. Countries also need prepared health systems, trained providers and community involvement to introduce it effectively.
For the partnership, the next test is converting a regulatory milestone into supplies and routine access. The stated end-2026 first-supply target and wider 2027 availability remain expectations, rather than confirmation that the medicine is already stocked across all 120 licensed countries.
JBizNews Desk | New York
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