Dr Reddy’s Laboratories has received tentative approval from the US Food and Drug Administration (USFDA) for its generic version of twice-yearly injectable lenacapavir, a long-acting medicine used as pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1. The approval was granted under the President’s Emergency Plan for AIDS Relief (PEPFAR) programme and covers adults and adolescents weighing at least 35 kg.

What the USFDA tentative approval covers

A tentative approval under PEPFAR confirms that a product meets the regulator’s standards for quality, safety and efficacy, allowing it to be supplied to programmes outside the United States. For Dr Reddy’s, it moves the injectable closer to use in the 120 low- and middle-income countries covered by Gilead Sciences’ voluntary licence.

• Product: generic lenacapavir injection, given twice a year for HIV PrEP.
• Pathway: USFDA tentative approval under PEPFAR.
• Reach: 120 countries under Gilead’s voluntary licence.
• Timeline: first supplies expected to reach countries before the end of 2026, with broader availability in eligible markets in 2027.

Licence, partners and a $40 price point

Gilead Sciences, the innovator, granted royalty-free voluntary licences to six generic manufacturers in 2024, including Dr Reddy’s, which received its licence in October 2024. In September 2025, the Hyderabad-based drugmaker signed an agreement with Unitaid, the Wits Reproductive Health and HIV Institute (Wits RHI) and the Clinton Health Access Initiative (CHAI) to support product development, speed up regulatory work and enable access at $40 per person per year.

Deepak Sapra, Chief Executive Officer for API and Services at Dr Reddy’s, said the approval validates the company’s work to develop and manufacture a complex long-acting injectable at an affordable price. CHAI Chief Executive Dr Neil Buddy Shah said getting a generic approved just 16 months after the originator, rather than a decade later, shows what is possible when access is prioritised from the start.

Why lenacapavir matters for HIV prevention

Lenacapavir is a first-in-class HIV-1 capsid inhibitor designed to act at multiple stages of the virus lifecycle. The World Health Organization recommends twice-yearly lenacapavir for HIV prevention, and the drug is also approved in several countries for treating adults with multi-drug-resistant HIV alongside other antiretrovirals. Two injections a year could remove the burden of a daily pill for people at risk.

Wider rollout still needs WHO prequalification and national regulatory approvals, and HIV-negative status must be confirmed before the first and each subsequent injection. India has made steady progress against the epidemic, as seen in Mizoram’s Saitual meeting all 95-95-95 HIV targets.

Status in India

In India, the Subject Expert Committee reviewing the drug recommended approval, according to ET Pharma. Final marketing approval from the Central Drugs Standard Control Organisation (CDSCO) is yet to be issued.

The nod adds to a busy regulatory season for Dr Reddy’s, which recently saw the USFDA close the inspection of its Srikakulam unit with a VAI status. It follows the company’s generic semaglutide launch plans and comes as Indian drugmakers push into complex generics such as Sun Pharma’s oral semaglutide.

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