Innovative licensing agreements continue to provide access to dolutegravir for HIV in high-burden countries

This year marks the fifth anniversary of the signing of two licensing agreements between HIV specialist drugmaker ViiV Healthcare and the Medicines Patent Pool (MPP) that have allowed generic manufacturers to produce and sell single and combination versions of dolutegravir (DTG) for adults and children in countries with the highest burden of HIV.

Currently, 18 generic manufacturers (17 sub-licensees under the MPP and Aurobindo Pharma via a separate direct voluntary licence agreement with ViiV Healthcare, which is majority-owned by GlaxoSmithKline (LSE: GSK), are authorized to produce and sell low-cost single or fixed-dose combination versions of DTG in all least developed, low-income, lower-middle income, and sub-Saharan Africa countries as well as some other upper middle-income countries (pediatric licence only), totalling 94 and 121 countries for the adult and pediatric agreements respectively.

These licensing agreements have also allowed generic manufacturers to include dolutegravir in a newly-developed fixed-dose combination, tenofovir disoproxil fumarate/ lamivudine/dolutegravir (TLD), which combines the WHO-preferred treatment regimen into a single pill.