On September 28, 2026, Kenyan officials announced that Nairobi-area manufacturer Universal Corporation Limited (UCL) is one of seven generic drugmakers to receive royalty-free voluntary licences from Merck. The licences cover generic versions of alimatravir (MK-8527), Merck's investigational once-monthly oral PrEP pill, and take effect if the drug is proven safe and effective and is approved. Capital FM reports that the other two African licensees are Aspen Pharmacare of South Africa and Quality Chemical Industries of Uganda. The remaining four are based in India. The Citizen (via Nation Africa) reports that the licences cover supply to 129 low- and middle-income countries.

Why It Matters

The PrEP market is splitting into several dosing formats: daily oral pills, Gilead's twice-yearly lenacapavir injection, and now a possible monthly pill. Lenacapavir launched first in rich markets and then reached low-income markets through licensing and regional deals, including the PAHO arrangement we covered in September. If alimatravir works, Merck's approach would let low- and middle-income markets get generic supply almost as soon as the drug is approved. Combined with a no-profit bridge supply, that would be a meaningful change in how HIV-prevention products are launched. For the telehealth and sexual-health platforms we cover, including Grindr's new PrEP business, MISTR and Freddie, a monthly pill would be a major retention tool. Adherence is the biggest weakness of daily PrEP, and a once-a-month regimen also suits subscription-style care. The caveat is that this is still a Phase 3 compound. None of this applies until the efficacy readouts arrive next year.

Normally, generic licensing comes after approval. Here it is happening while alimatravir is still in Phase 3. Capital FM quotes Merck as saying this is the first time sub-Saharan African generic manufacturers have been included from the start of a voluntary licensing arrangement for an investigational HIV-prevention medicine. Two Phase 3 trials are under way. EXPrESSIVE-10 is enrolling adolescent girls and young women in Kenya, Uganda and South Africa. EXPrESSIVE-11 is testing the drug in populations at higher likelihood of HIV acquisition across 16 countries. Merck has said Phase 3 results are expected next year. According to The Citizen, Merck has also committed to an at-no-profit "bridge" supply for low- and middle-income countries to cover the gap between any approval and the arrival of generics. Unitaid is providing technical and financial support to UCL, QCIL and Aspen, and the Gates Foundation is supporting late-stage development.

Kenya's Medical Services Principal Secretary Dr Ouma Oluga said he had "brought this achievement home from the just concluded UNGA 81." Foreign Affairs PS Korir Sing'oei said the licence makes Kenya one of three African countries set to produce the drug for African markets. In February, Kenya became the first East African country to launch lenacapavir, Gilead's twice-yearly injectable PrEP.

Sources

Update — 2026-10-02

Initial entry — story first created.