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LOPINAVIR, RITONAVIR (LPV/r) PAEDIATRICS

In November 2014, the MPP signed a licensing agreement with AbbVie for lopinavir (LPV) and ritonavir (r) for paediatric use. The agreement permits generic manufacturers to produce low-cost versions of LPV/r for paediatric use for at least 102 countries. The licence also allows sales of LPV/r for paediatric use in additional countries where there is no patent infringement. As a result, countries that together are home to 98.8% of children living with HIV in low- and middle-income countries, benefit from the licence.

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 formulation of LPV/r and RTV anywhere in the world.
Geographical scope for sale Allows for sale of LPV/r and RTV in at least 102 countries (see “Sales outside the licensed territory”).
Sales outside the licensed territory Sales outside the 102 countries are permitted if no granted patent is being infringed. This includes cases in which a compulsory licence is issued. It is estimated that licensees can thus sell the product in 125 countries where 98.8% of children living with HIV reside.
Royalties The license is royalty free.
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 LPV or RTV 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 LPV/r and RTV worldwide at the time of licence signing.
Additional flexibilities for licensees: Licensees have the right to challenge any of the licensed patents.
Country List
Afghanistan, Algeria, Angola, Armenia, Azerbaijan, 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, Dominican Republic, Egypt, El Salvador, Equatorial Guinea, Eritrea, Ethiopia, Gabon, Gambia, Georgia, Ghana, Guatemala, Guinea, Guinea-Bissau, Guyana, Haiti, Honduras, Indonesia, Kenya, Kiribati, Korea Dem. Republic, Kyrgyzstan, Laos, Lesotho, Liberia, Libya, Madagascar, Malawi, Malaysia, Maldives, Mali, Marshall Islands, Mauritania, Mauritius, Micronesia, Moldova, Mongolia, Morocco, Mozambique, Myanmar, Namibia, Nepal, Nicaragua, Niger, Nigeria, Pakistan, Panama, Papua New Guinea, Paraguay, Peru, 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, Thailand, Timor-Leste, Togo, Tunisia, Turkmenistan, Tuvalu, Uganda, Uzbekistan, Vanuatu, Vietnam, West Bank and Gaza, Yemen, Zambia, Zimbabwe

GENERIC PARTNERS AND PRODUCT DEVELOPERS

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