Dolutegravir was approved by the United States Food and Drug Administration in 2013. Dolutegravir is also known as DTG.
Following the license between the Medicines Patent Pool and ViiV Healthcare, market competition for dolutegravir is likely to take place in countries covered by the license, as well as in those countries in which dolutegravir is not patented.
The compound patent for dolutegravir is expected to expire in 2026. The patent has been granted in Algeria, China, Colombia, EAPO member countries, Indonesia, Mexico, Morocco, Philippines, South Africa, Turkey and Ukraine, and is pending in Brazil, Egypt, India, Malaysia, Nigeria and Viet Nam.
In April 2014, dolutegravir was licensed to the Medicines Patent Pool (through separate licenses for adult and pediatric formulations). The pediatric license includes 121 countries. The adult license includes all countries in sub-Saharan Africa, least-developed countries, low-income countries, Egypt, India, Indonesia, Philippines, Turkmenistan and Viet Nam. In addition, the licenses allow for the sale of generic versions of dolutegravir outside the licensed countries where there are no patents in force. The license granted to Medicines Patent Pool has been sub-licensed to nine companies.
A combination containing dolutegravir (DTG) plus ABC/3TC (abacavir/lamivudine), has received regulatory approval. In addition to the patents on DTG and ABC, patents on the combinations ABC/3TC and ABC/3TC/DTG may have an impact on the use of a regimen consisting of ABC/3TC and DTG.
The combination patent on ABC/3TC/DTG, which is expected to expire in 2031, has been granted in Colombia, Mexico, Mongolia and South Africa, and is pending in Albania, Algeria, ARIPO member countries, EAPO member countries, China, Costa Rica, Dominican Republic, Ecuador, Egypt, India, Indonesia, Malaysia, Morocco, Nigeria, Peru, Philippines, Thailand, Tunisia, Ukraine and Viet Nam.
The Medicines Patent Pool license on dolutegravir also covers combinations containing abacavir and dolutegravir with the same geographical scope.