First generic HIV prevention injection clears FDA hurdle

The FDA has granted tentative approval to Dr. Reddy’s Laboratories for the first generic version of injectable lenacapavir for HIV prevention, marking a significant milestone in expanding access to long-acting pre-exposure prophylaxis (PrEP).

The generic formulation is expected to cost approximately $40 per person annually across 120 designated low- and middle-income countries (LMICs), offering a more affordable alternative to the originator product.

How lenacapavir works

Administered twice yearly, lenacapavir offers an alternative to daily oral PrEP, potentially addressing adherence challenges and improving prevention coverage among populations at increased risk of HIV.

Clinical trials have demonstrated near-complete protection against HIV acquisition, highlighting the potential of long-acting prevention strategies to strengthen global HIV prevention programmes.

The generic product was developed by Dr. Reddy’s with support from Unitaid, the Clinton Health Access Initiative (CHAI) and Wits RHI, through a collaborative initiative designed to accelerate development and affordable access.

Dr Neil Buddy Shah, CEO, CHAI, highlighted the significance of the development timeline, saying: “Getting a generic approved just 16 months after the originator, rather than a decade later, shows what’s possible when we prioritize access from the start. This should be the new standard for global health.”

Patent and licensing

The approval is particularly significant because lenacapavir remains under patent protection.

Gilead Sciences, which markets the originator product under the brand name Yeztugo, retains key intellectual property rights, with relevant patent protection extending into the 2030s.

Generic market entry has been made possible through voluntary licensing agreements established by Gilead in 2024 with six generic manufacturers, including Dr. Reddy’s.

These royalty-free agreements permit generic production and supply across the 120 designated LMICs, enabling earlier market entry while maintaining Gilead’s patent protection in markets outside the licensing arrangements.

Dr Philippe Duneton, Executive Director, Unitaid, highlighted the importance of early investment in accelerating access, saying: “Unitaid’s early risk-taking is helping shorten the time between a scientific breakthrough and real access in countries.”

Market rollout

The FDA’s tentative approval confirms that the generic formulation has met relevant regulatory requirements. However, commercial marketing remains subject to applicable patent, licensing and national regulatory restrictions.

Nevertheless, initial supplies are expected to reach selected countries before the end of 2026, with broader availability anticipated in 2027.