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ATAZANAVIR (ATV)

In December 2013, the MPP announced an agreement with biopharmaceutical company Bristol-Myers Squibb to increase access to a key HIV medicine, atazanavir (ATV), part of the WHO-preferred second-line treatment for adults and children. In July 2017, the MPP signed an extension of its licence agreement to include 12 additional countries, namely, Algeria, Cook Islands, Egypt, Equatorial Guinea, Indonesia, Malaysia, Morocco, Niue, the Philippines, Tunisia, Ukraine and Vietnam. The licence allows generic manufacture of ATV for sale in at least 122 countries that together are home to 89% of people living with HIV in low- and middle-income countries.

Key Features
Eligibility for sublicences Sublicences can be issued to qualified entities worldwide.
Manufacturing Allows for the manufacturing of generic active pharmaceutical ingredient and finished formulations of ATV anywhere in the world.
Geographical scope for sale Allows for sale in at least 122 countries where 89% of people with HIV in low- and middle-income countries live.
Sales outside the licensed territory Enables manufacturers that do not rely on BMS technology to sell outside the 122 countries if no granted patent is being infringed. This includes cases in which a compulsory licence is issued.
Royalties Three percent royalty for adult formulations in countries where granted patents on ATV are in force. Royalties to be collected by MPP and channeled back to a community-based HIV organization in the country paying the royalty. Royalties not payable for paediatric formulations or for sales of adult formulations in Sub-Saharan Africa and India.
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 ATV with other ARVs and to develop 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 worldwide at the time of licence signing.
Technology transfer A technology transfer package is provided to all the sub-licensees, but there is no obligation to use the technology.

 

Country List
Afghanistan, Algeria, Angola, Antigua and Barbuda, Armenia, Azerbaijan, Bangladesh, Belarus, Belize, Benin, Bhutan, Bolivia, Botswana, Burkina Faso, Burundi, Cambodia, Cameroon, Cape Verde, Central African Republic, Chad, Comoros, Cook Islands, Costa Rica, Côte d’Ivoire, Cuba, Democratic Republic of the Congo, Djibouti, Dominica, Dominican Republic, Ecuador, Egypt, El Salvador, Equatorial Guinea, Eritrea, Ethiopia, Fiji, Gabon, Gambia, Georgia, Ghana, Grenada, Guatemala, Guinea, Guinea-Bissau, Guyana, Haiti, Honduras, India, Indonesia, Iraq, Jamaica, Kazakhstan, 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, Nauru, Nepal, Nicaragua, Niger, Nigeria, Niue, Pakistan, Palau, Panama, 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, St. Kitts and Nevis, St. Vincent and the Grenadines, Sudan, Suriname, Swaziland, Syrian Arab Republic, Tajikistan, Tanzania, Timor-Leste, Togo, Tonga, Tunisia, Turkmenistan, Tuvalu, Uganda, Ukraine, Uzbekistan, Vanuatu, Vietnam, West Bank and Gaza, Yemen, Zambia, Zimbabwe

Quality assured formulations from MPP generic partners: Atazanavir capsule 100mg, Atazanavir capsule 150mg, Atazanavir capsule 200mg, Atazanavir capsule 300mg, Atazanavir/ritonavir tablet 300/100mg

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