MPP Licences for Dolutegravir (DTG)

The product

Dolutegravir (DTG) is a new integrase inhibitor approved by the US Food and Drug Administration (FDA) in August 2013 and the European Medicines Agency (EMA) in January 2014.

The MPP licences

In April 2014, the MPP announced two agreements with ViiV Healthcare — one for paediatric formulations of DTG and another for adult formulations of DTG and abacavir (ABC) in combination with DTG. The licensing agreements were amended in April 2016 to include all lower middle-income countries.

Key features of the licences

Eligibility for sub-licences Sub-licences 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 Sub-licensees 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.

Transparency

The full texts of the licences on DTG are public. The licence agreement covering DTG paediatrics is available here and the licence covering DTG and ABC adults is available here.

Sub-licensees

As of August 2017, DTG has been sublicensed to Cipla, Desano, Emcure, Hetero, Laurus, Lupin, Microlabs, Mylan, Strides, Macleods, Anhui Biochem, Sun, Zhejiang Huahai, and Dr Reddy’s

Quality assured formulations from MPP generic partners

Tenofovir disoproxil fumarate/lamivudine/dolutegravir 50 mg/300 mg/300 mg

 

 

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