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DOLUTEGRAVIR – ADULT (DTG)

In April 2014, the MPP and ViiV Healthcare announced two licensing agreements to accelerate access to dolutegravir (DTG), a promising new antiretroviral, for both adult and paediatric care. The agreements allow generic manufacturers to produce low-cost versions of DTG for at least 92 countries for the adult agreement and 121 countries for the paediatric agreement.

The two parties extended the adult licence to cover all remaining lower middle-income countries in April 2016. The amendment specifically benefits four countries with patents – Armenia, Moldova, Morocco and Ukraine – that were not included in the initial 2014 agreement. As a result, countries that together are home to 94%[1] of adults and 99% of children living with HIV in low- and middle-income countries, are covered by the licence.

[1]Coverage rates at time of announcement. Current coverage rates based on World Bank reclassification of countries is 90%.

Key Features
Eligibility for sublicences Sublicences can be issued to qualified entities worldwide.
Manufacturing Allows manufacturing of active pharmaceutical ingredient and finished formulations anywhere in the world.
Geographical scope for sale The paediatric licence allows for sale in 121 countries where 99.3% of children living with HIV in the developing world reside. The adult licence territory covers at least 92 countries with 90% of people living with HIV (see “Sales outside the licensed territory”).
Sales outside the licensed territory Sales outside the licensed countries are permitted where there is no granted patent in force (54 additional countries) or where sales of a generic version do not infringe on an existing patent, such as in cases in which a compulsory licence has been issued. As a result, sub-licensees will likely be able to sell generic DTG in 131 countries representing 93.4% of people living with HIV in the developing world.
Royalties The adult licence is royalty-free for 82 countries and royalty-bearing for ten countries namely: Philippines; India and Vietnam and Moldova (5%); Egypt, Indonesia,  Morocco, Armenia and Ukraine  (7.5%); Turkmenistan (10%) ; There are no royalties for paediatric formulations.
Quality assurance Licensees must obtain approval from WHO Pre-qualification, or a Stringent Regulatory Authority. Where such approval is not yet available, temporary approval from a WHO Expert Review Panel may be obtained.
Combinations Sublicensees have the right to combine DTG with other ARVs and to develop suitable new fixed-dose combinations.
Data exclusivity Data exclusivity is waived in countries with such form of protection, thus facilitating regulatory approval of generics.
Patent disclosure The licences disclose the list of pending and granted patents in the 121 countries and granted patents in other LMICs.
Additional flexibilities for licensees Licensees can challenge any of the licensed patents.

 

Country List
Afghanistan, Angola, Armenia, Bangladesh, Benin, Bhutan, Bolivia, Botswana, Burkina Faso, Burundi, Cambodia, Cameroon, Cape Verde, Central African Republic, Chad, Comoros, Côte d’Ivoire, Democratic Republic of the Congo, Djibouti, E.Timor, Egypt, El Salvador, Equatorial Guinea, Eritrea, Ethiopia, Gabon, Gambia, Georgia, Ghana, Guatemala, Guinea, Guinea-Bissau, Guyana, Haiti, Honduras, India, Indonesia, Kenya, Kiribati, Korea Dem. Republic, Kosovo, Kyrgyzstan, Laos, Lesotho, Liberia, Madagascar, Malawi, Mali, Mauritania, Mauritius, Micronesia, Moldova, Morocco, Mozambique, Myanmar, Namibia, Nepal, Nicaragua, Niger, Nigeria, Pakistan, Papua New Guinea, Philippines, Republic of the Congo, Rwanda, Samoa, Sao Tome and Principe, Senegal, Seychelles, Sierra Leone, Solomon Islands, Somalia, South Africa, South Sudan, Sri Lanka, Sudan, Swaziland, Syrian Arab Republic, Tajikistan, Tanzania, Togo, Turkmenistan, Tuvalu, Uganda, Ukraine, Uzbekistan, Vanuatu, Vietnam, West Bank and Gaza, Yemen, Zambia, Zimbabwe

Quality assured formulations from MPP generic partners: Tenofovir disoproxil fumarate/lamivudine/dolutegravir 50 mg/300 mg/300 mg

GENERIC PARTNERS AND PRODUCT DEVELOPERS

Click the logos to access the sublicensing agreements: