What We Do » Licence Overview » Products Licensed » ELVITEGRAVIR (EVG)

ELVITEGRAVIR (EVG)

In July 2011, the MPP signed a licence agreement with Gilead Sciences for the production of elvitegravir (EVG) and combinations containing elvitegravir. The agreement allows generic manufacture of EVG in at least 100 countries that together. In June 2015, the two parties amended the agreement to allow manufacturers from China and South Africa to produce EVG. In September 2017, the two parties amended the agreement to allow for an extension of the Territory for EVG to 109 countries that are home to 88.4% of people living with HIV in low- and middle-income countries.

Key Features
Eligibility for sublicences Sublicences can be issued to qualified entities in China, India and South Africa.
Manufacturing Allows manufacturing of active pharmaceutical ingredient and finished formulations in China, India and South Africa.
Geographical scope for sale Allows for sale of EVG in 109 countries that are home to 88.4% 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 5% of net sales of finished product. There are no royalties for the sale of the active pharmaceutical ingredient or paediatric formulations.
Quality assurance Licensees must obtain approval from WHO Pre-qualification, the US Food and Drug Administration or the European Medicines Agency.
Combinations Sublicensees have the right to combine EVG 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 109 countries, as of September 2017
Technology transfer All Indian sublicensees 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.

 
See related licence

Country List
Afghanistan, Angola, Anguilla, Antigua and Barbuda, Armenia, Bahamas, Bangladesh, Barbados, 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, Ecuador, El Salvador, Equatorial Guinea, Eritrea, Eswatini, 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, Maldives, Mali, Mauritania, Mauritius, Moldova, Mongolia, Mozambique, Myanmar, Namibia, Nauru, Nepal, Nicaragua, Niger, Nigeria, Pakistan, Palau, Papua New Guinea, 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, Syrian Arab Republic, Tajikistan, Tanzania, Thailand, Timor-Leste, Togo, Tonga, Trinidad and Tobago, Turkmenistan, Turks and Caicos Islands, Tuvalu, Uganda, Uzbekistan, Vanuatu, Vietnam, Yemen, Zambia, Zimbabwe

Update on progress of MPP licensees: take a look at our table updated every quarter

GENERIC PARTNERS AND PRODUCT DEVELOPERS

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