What We Do » Licence Overview » Products Licensed » BICTEGRAVIR (BIC)

BICTEGRAVIR (BIC)

In September 2017, the MPP signed a licensing agreement with Gilead Sciences for Bictegravir, benefiting at least 116 countries that together are home to 89.8% of people living with HIV in low- and middle-income countries. The BIC licence broadened the MPP’s collaboration with Gilead and the parties’ earlier licence for the production of tenofovir alafenamide (TAF), tenofovir disoproxil fumarate (TDF), emtricitabine (FTC), cobicistat (COBI), and elvitegravir (EVG).

Key Features
Eligibility for sublicences Sublicences can be issued to entities based in China, India and South Africa
Manufacturing Allows manufacturing of active pharmaceutical ingredient and finished formulations in India, China and South Africa
Geographical scope for sale Allows for sale of BIC in 116 countries representing 89.8% of people living with HIV in low- and middle-income countries
Sales outside the licensed territory Sublicensees may supply outside the licensed territory if a country issues a compulsory licence
Royalties The royalty rate is five (5) percent of net sales of finished product.  There are no royalties for the sale of the active pharmaceutical ingredient or paediatric formulations
Quality assurance Licensees to manufacture in accordance with WHO Pre-qualification standards, standards of the European Medicines Agency, or USFDA tentative approval standards. Licensees to apply for WHO-Prequalification in the event BIC is included in the WHO Guidelines or in the expression of interest for WHO pre-qualification of medicines
Combinations Sublicensees have the right to combine BIC 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 all pending and granted patents in the 116 licensed countries
Technology transfer All Indian and South-African sub-licensees benefit from a one-time technology transfer
Additional flexibilities for licensees Licensees have the right to terminate the agreement at any time on a product-by-product basis and can challenge any of the licensed patents
Country List
Afghanistan, Angola, Anguilla, Antigua and Barbuda, Armenia, Aruba, Bahamas, Bangladesh, Barbados, Belarus, Belize, Benin, Bhutan, Bolivia, Botswana, British Virgin Islands, Burkina Faso, Burundi, Cambodia, Cameroon, Cape Verde, Central African Republic, Chad, Comoros, 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, Jamaica, Kazakhstan, Kenya, Kiribati, Kyrgyzstan, Laos, Lesotho, Liberia, Madagascar, Malawi, Malaysia, Maldives, Mali, Mauritania, Mauritius, Moldova, Mongolia, Montserrat, Mozambique, Myanmar, Namibia, Nauru, Nepal, Nicaragua, Niger, Nigeria, Pakistan, Palau, Papua New Guinea, Philippines, Republic of the Congo, Rwanda, Saint Kitts and Nevis, Saint Lucia, Saint Vincent & the Grenadines, Samoa, Sao Tome and Principe, Senegal, Seychelles, Sierra Leone, Solomon Islands, Somalia, South Africa, South Sudan, Sri Lanka, Sudan, Suriname, Swaziland, Syrian Arab Republic, Tajikistan, Tanzania, Thailand, Timor-Leste, Togo, Tonga, Trinidad and Tobago, Turkmenistan, Turks and Caicos Islands, Tuvalu, Uganda, Ukraine, Uzbekistan, Vanuatu, Vietnam, Yemen, Zambia, Zimbabwe
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