Merck lines up generic makers for a monthly HIV prevention pill before it's approved

Merck signed licensing deals with seven generic manufacturers to supply its investigational monthly PrEP pill in 129 countries — before phase 3 data exists.

On July 24, 2026, Merck announced nonexclusive voluntary licensing agreements with seven generic manufacturers to enable access to alimatravir, an investigational monthly oral HIV prevention pill also known as MK-8527. The deals cover Aspen Pharmacare, Quality Chemical Industries and UCL Kenya in sub-Saharan Africa, plus Aurobindo, Cipla, Emcure and Viatris in India, and are intended to supply 129 low- and middle-income countries. Merck says it is the first time sub-Saharan African producers were included in an initial voluntary license for HIV.

Alimatravir is a nucleoside reverse transcriptase translocation inhibitor. A monthly pill would sit between daily oral PrEP and Gilead's twice-yearly lenacapavir injection, offering a different option for people who prefer pills. The unusual part is timing: Merck set up the generic supply chain before its phase 3 prevention trial finished enrolling or produced any data. The company timed the announcement to the 26th International AIDS Conference in Rio de Janeiro.

If the drug works, pre-arranged generic licensing means it could reach poorer countries far faster and cheaper than the usual wait after approval — the friction that historically delayed HIV medicines by years. Getting African manufacturers into the initial license also builds regional supply capacity.

The large caveat: alimatravir is still investigational, and everything depends on successful trials and regulatory approval. Merck previously abandoned a related compound, islatravir, for PrEP after a safety signal involving drops in lymphocyte and CD4+ T-cell counts. Access programs also draw scrutiny over whether supply is adequate; MSF called Gilead's lenacapavir supply 'not nearly enough.'

Source: Fierce Biotech