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RALTEGRAVIR (RAL) PAEDIATRICS

The MPP signed a licence agreement with Merck Sharp & Dohme (MSD) for raltegravir (RAL) for paediatric use. The WHO recommends raltegravir as a second-line treatment for children from four weeks to the age of three. The licence covers at least 92 countries covering 98% of children living with HIV in low and middle-income countries. The licence also allows additional countries, where RAL is not patented, to procure generic versions.

Key Features
Eligibility for sublicences Sublicences can be issued to any qualified entity worldwide.
Manufacturing Allows manufacturing of the active pharmaceutical ingredient and the finished formulations of RAL anywhere in the world.
Geographical scope for sale Allows for sale of paediatric RAL in at least 92 countries where 98.1% of children living with HIV in the developing world reside (see “Sales outside the licensed territory”).
Sales outside the licensed territory Sales to countries outside the 92 countries are permitted if no granted patent is being infringed. This includes cases in which a compulsory licence has been issued.
Royalties The license is royalty free.
Quality assurance Licensees must obtain approval from WHO Pre-qualification, or a Stringent Regulatory Authority.
Combinations Sublicensees have the right to combine RAL 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 licence discloses the list of pending and granted patents on RAL in the 92 countries at the time of licence signing.
Additional flexibilities for licensees Licensees have the right to 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, 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, Kyrgyzstan, Lao PDR, Lesotho, Liberia, Madagascar, Malawi, Maldives, Mali, Mauritania, Mauritius, Micronesia, Moldova, Mongolia, Morocco, Mozambique, Myanmar, Namibia, Nepal, Nicaragua, Niger, Nigeria, Pakistan, Papua New Guinea, Paraguay, Philippines, Republic of the Congo, Rwanda, Samoa, Sao Tome and Principe, Senegal, Seychelles, Sierra Leone, Solomon Islands, Somalia, South Africa, South Sudan, Sri Lanka, Swaziland, Syrian Arab Republic, Tajikistan, Tanzania, Timor-Leste, Togo, Tuvalu, Uganda, Ukraine, Uzbekistan, Vanuatu, Vietnam, West Bank and Gaza, Yemen, Zambia, Zimbabwe

GENERIC PARTNERS AND PRODUCT DEVELOPERS

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