FDA Approves Generic Lenacapavir Injection for HIV Prevention at $40 a Year

The US Food and Drug Administration has granted tentative approval to Indian drugmaker Dr Reddy's Laboratories for a generic version of lenacapavir, the twice-yearly injectable used to prevent HIV. The approval opens a path for the medicine to be supplied at about $40 per person per year in 120 low- and middle-income countries covered by licensing agreements.

Lenacapavir, sold by Gilead Sciences under the brand Yeztugo in the United States, provides nearly complete protection against HIV acquisition with one injection every six months. The originator product was approved by the FDA in June 2025. The generic approval arrived roughly 16 months later, faster than typical timelines for complex long-acting injectables.

Dr Reddy's is the first of six companies licensed by Gilead to receive this tentative approval. The licensing agreements, signed in October 2024, are royalty-free and non-exclusive for the 120 eligible countries. The generic cannot be sold in the United States while the originator's patents remain in force. In the US the list price for Yeztugo is about $28,000 per year before insurance adjustments.

Global health groups including Unitaid, the Clinton Health Access Initiative and Wits Reproductive Health and HIV Institute supported the development and regulatory process. Initial supplies are expected to reach some low-income countries by the end of 2026, with broader availability in 2027. Zambia is among the countries likely to receive early shipments. More than 125,000 people in ten early-adopter African countries have already started the branded version.

Deepak Sapra of Dr Reddy's described the approval as a moment of pride for the company, noting that manufacturing a complex long-acting injectable at an affordable price required substantial scientific and production capacity. The $40 annual price matches the current cost of daily oral PrEP tablets in many settings.

The FDA used a pathway that allows review of HIV medicines intended for use outside the United States. Tentative approval is the standard classification when the originator patent is still active. National regulatory authorities in many countries often accept or expedite review after FDA tentative approval.

Access advocates have long argued that long-acting injectables can overcome adherence challenges associated with daily pills, particularly in high-incidence regions. The price reduction is expected to allow programmes to scale prevention more rapidly than was possible with the branded product alone.

Gilead has said the US list price is comparable to other forms of pre-exposure prophylaxis. The company granted the voluntary licences specifically to expand access in high-burden, resource-limited settings. Production scale-up and national regulatory approvals will determine the precise timeline for widespread availability.

The approval does not change the status of the branded product in high-income markets. It does, however, create a concrete supply channel for the 120 licensed countries at a price point that existing prevention budgets can absorb. Implementation will depend on procurement arrangements, cold-chain capacity for the injectable, and local training for health workers.