What We Do » Licence Overview » Products Licensed » LOPINAVIR, RITONAVIR (LPV/r)

LOPINAVIR, RITONAVIR (LPV/r)

In December 2015, the MPP and AbbVie signed a new licensing agreement to increase access to lopinavir, ritonavir (LPV/r), a WHO-recommended second-line treatment, in all 54 African countries.

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 all African countries.
Sales outside the licensed territory Sales outside Africa are permitted if no granted patent is being infringed. This includes cases in which a compulsory licence is issued.
Royalties The licence 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/r 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.
Additional flexibilities for licensees Licensees have the right to challenge the validity of any of the licensed patents.
Country List
Algeria, Angola, Benin, Botswana, Burkina Faso, Burundi, Cameroon, Cape Verde, Central African Republic, Chad, Comoros, Côte d’Ivoire, Democratic Republic of the Congo, Djibouti, Egypt, Equatorial Guinea, Eritrea, Ethiopia, Gabon, Gambia, Ghana, Guinea, Guinea-Bissau, Kenya, Lesotho, Liberia, Libya, Madagascar, Malawi, Mali, Mauritania, Mauritius, Morocco, Mozambique, Namibia, Niger, Nigeria, Republic of the Congo, Rwanda, Sao Tome and Principe, Senegal, Seychelles, Sierra Leone, Somalia, South Africa, South Sudan, Sudan, Swaziland, Tanzania, Togo, Tunisia, Uganda, Zambia, Zimbabwe

GENERIC PARTNERS AND PRODUCT DEVELOPERS

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