A generic version of the twice-yearly HIV prevention medicine lenacapavir has received tentative approval from the US Food and Drug Administration. Its manufacturer, India’s Dr. Reddy’s Laboratories, announced the decision on 2 November.

The planned price is US$40 per person for a year’s supply under an agreement with global health partners. It covers 120 countries included in Gilead’s voluntary licence. Initial supplies are expected before the end of 2026; the company and its partners expect wider availability in 2027.

National regulatory approvals still have to be worked through. The announcement gives no date for a local clinic launch and no price for an individual patient.

WHO backed lenacapavir as an additional form of PrEP, short for pre-exposure prophylaxis, in July 2025. People can struggle to keep up with daily pills because of stigma or difficulty getting supplies. A medicine given at six-month intervals adds a different way to prevent HIV.

In that announcement, WHO included men who have sex with men and transgender people among the populations disproportionately affected by HIV. Access to testing goes with access to the medicine: Dr. Reddy’s says people must have their HIV-negative status confirmed before starting it and before each later injection.

The FDA’s “tentative” designation concerns patents and exclusivity. A product may meet the agency’s approval standards and still be barred from sale in the US for those reasons. Eligible medicines can, however, be purchased for use abroad through its HIV programme.