Merck licenses experimental HIV pill to generic makers in 129 countries

• The agreements cover 129 countries accounting for a substantial majority of new HIV diagnoses globally, with licensees including three sub-Saharan African manufacturers (Aspen Pharmacare, Quality Chemical Industries, UCL) and four Indian companies (Aurobindo, Cipla, Emcure, Viatris)
• Alimatravir is still in late-stage trials with results expected in the second half of 2025, designed to provide one month of HIV-1 protection starting within one hour after dosing
• This follows similar 2024 action by Gilead Sciences, which granted royalty-free licenses for its HIV prevention drug lenacapavir in 120 low-income countries, reflecting WHO calls for improved access to affordable HIV medicines

Summary: Merck Licenses Experimental HIV Pill to Generic Manufacturers

Merck announced Friday it has signed seven voluntary licensing agreements allowing generic drug manufacturers to produce and sell lower-cost versions of its experimental once-monthly oral HIV pill, alimatravir, across 129 low- and lower-middle-income countries.

Key Licensing Partners:

• Three sub-Saharan African manufacturers: Aspen Pharmacare Holdings, Quality Chemical Industries, and UCL
• Four Indian companies: Aurobindo, Cipla, Emcure, and Viatris

Significant Details:

• The royalty-free agreements cover both public and private sectors in countries accounting for the majority of new global HIV diagnoses
• This marks the first time sub-Saharan African manufacturers have been included in such licenses from the outset, according to Gregg Szabo, head of Merck's global vaccines and infectious diseases unit
• Alimatravir remains in late-stage development with patient enrollment ongoing; trial results are not expected until the second half of 2025
• The drug is designed to provide one month of HIV-1 protection within one hour of dosing
• Merck is investing early in manufacturing capacity while trials continue, giving generic licensees time to scale up production

Market Context:

This initiative follows a similar move by Gilead Sciences in 2024, which granted royalty-free licenses for lenacapavir, its HIV prevention medicine, in 120 low and lower-middle-income countries. The World Health Organization has actively encouraged such voluntary licensing arrangements and increased generic competition to improve global access to affordable HIV treatments.

The proactive licensing strategy demonstrates pharmaceutical industry response to public health advocacy for expanded HIV treatment access in resource-limited regions.