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DACLATASVIR (DAC)

In November 2015, the MPP announced a licensing agreement with Bristol-Myers Squibb covering the direct-acting antiviral (DAA) drug, daclatasvir (DAC), and its combinations. The agreement allows generic manufacture of the hepatitis C treatment for sale in at least 112 countries that together are home to 65.4% of people living with HCV 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 DCV anywhere in the world.
Geographical scope for sale Allows for sale in at least 112 countries where 65.4% of people living with HCV 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 112 countries if no granted patent is being infringed. This includes cases in which a compulsory licence is issued.
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 DCV with other drugs 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 sublicensees, but there is no obligation to use the technology. Information necessary for registration is also provided.

Seven sublicensees, namely Aurobindo, Cipla, Hetero, Laurus, Mylan, Natco and Zydus Cadila have taken the technical decision not to rely on the licensed technology transfer package.

Country List
Afghanistan, Algeria, Angola, Azerbaijan, Bangladesh, 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, El Salvador, Equatorial Guinea, Eritrea, Ethiopia, Fiji, Gabon, Gambia, Georgia, Ghana, Grenada, Guatemala, Guinea, Guinea-Bissau, Guyana, Haiti, Honduras, India, Indonesia, Iraq, Jamaica, Kenya, Kiribati, Korea Dem. Republic, Laos, Lesotho, Liberia, Libya, Madagascar, Malawi, Maldives, Mali, Marshall Islands, Mauritania, Mauritius, Micronesia, Mongolia, Morocco, Mozambique, Myanmar, Namibia, Nauru, Nepal, Nicaragua, Niger, Nigeria, Niue, Pakistan, Palau, Panama, 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, St Lucia, St. Vincent and the Grenadines, Sudan, Suriname, Swaziland, Syrian Arab Republic, Tanzania, Timor-Leste, Togo, Tonga, Tunisia, Turkmenistan, Tuvalu, Uganda, Uzbekistan, Vanuatu, Vietnam, West Bank and Gaza, Yemen, Zambia, Zimbabwe

GENERIC PARTNERS AND PRODUCT DEVELOPERS

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