Dr. Reddy’s secures US FDA tentative approval for generic lenacapavir for HIV prevention

KENYA—Dr. Reddy’s Laboratories has secured tentative approval from the US Food and Drug Administration (FDA) for the first generic version of lenacapavir, advancing efforts to expand access to twice-yearly HIV prevention injections in 120 low- and middle-income countries.

The regulatory milestone comes 16 months after Gilead Sciences received approval for the original product.

Initial supplies of the generic injection are expected to reach eligible countries by the end of 2026, potentially offering a more affordable alternative for people who struggle to take daily oral pre-exposure prophylaxis (PrEP).

The generic is expected to cost approximately US$40 per person annually, placing it within the price range of oral PrEP.

This could widen access to long-acting HIV prevention, particularly among populations that struggle with daily medication adherence.

Partnerships accelerate generic development

The approval follows a pricing agreement announced in September 2025 involving Unitaid, Wits RHI, the Clinton Health Access Initiative (CHAI) and Dr. Reddy’s.

The partnership combined an early commitment to affordable pricing with financial, technical and regulatory support to accelerate product development and market entry.

Demand for lenacapavir is already emerging across Africa.

More than 125,000 people in 10 early-adopter African countries have started using Gilead’s original injection, according to the partners.

Unitaid Executive Director Dr. Philippe Duneton said early investment and collaboration had helped shorten the time between scientific breakthroughs and access in lower-income countries.

He noted that faster availability of lenacapavir could expand HIV prevention choices for young women in Africa and support efforts to reduce new infections.

CHAI Chief Executive Officer Dr. Neil Buddy Shah said the twice-yearly injection could address adherence challenges associated with daily HIV prevention pills.

 He added that the generic approval brings the partners closer to making the treatment available to millions more people at the projected annual price of US$40.

Manufacturing and delivery remain key priorities

However, affordable pricing and regulatory clearance will not automatically guarantee widespread access.

Countries will need appropriate healthcare infrastructure, trained providers and community engagement to introduce the injection effectively.

Wits RHI Director of Implementation Science Professor Saiqa Mullick said health systems must prepare to deliver the new prevention option, particularly to underserved populations.

She emphasised that affordability alone would not ensure equitable access without effective delivery systems.

Dr. Reddy’s said developing and manufacturing an affordable long-acting injectable required substantial scientific and production capabilities.

The FDA’s tentative approval provides a regulatory basis for further market preparation, although national regulatory approvals and country-level introduction processes remain necessary.

The partners are working with governments, communities, the Global Fund, the US Bureau of Global Health Security and Diplomacy, the Gates Foundation and other organisations to support product introduction, community engagement and evidence generation.

Voluntary licensing supports generic competition

The development builds on voluntary licences Gilead granted to six generic manufacturers, including Dr. Reddy’s, in late 2024.

These agreements are intended to support the supply of lower-cost versions of lenacapavir to eligible low- and middle-income countries.

Dr. Reddy’s combined the drug’s HIV prevention and treatment indications in a single application under the FDA’s 505(b)(2) regulatory pathway.

The application received priority review, helping accelerate the regulatory assessment.

The entry of generic manufacturers could reshape the supply landscape for long-acting HIV prevention by introducing additional production capacity and supporting price competition.

However, manufacturing scale, regulatory clearances, procurement arrangements, and distribution networks will influence the pace of access across eligible markets.

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