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GLECAPREVIR/PIBRENTASVIR (G/P)

In November 2018, the MPP signed a royalty-free licence agreement with AbbVie for glecaprevir/pibrentasvir (G/P) – a World Health Organization (WHO)-recommended treatment for people living with chronic hepatitis C (HCV). The licence enables quality-assured manufacturers to develop and sell generic medicines containing G/P in 99 low- and middle-income countries (LMICs) and territories at affordable prices, enabling access to and treatment scale-up with the most effective pan-genotypic regimens.

The MPP invites Expression of Interest (EoI) from potential sublicensees based anywhere in the covered territory and in India for sublicences to manufacture and sell glecaprevir/pibrentasvir:

Key Features
Eligibility for sublicences Non exclusive sublicences can be issued to any qualified entity in the Territory and in India.
Manufacturing Allows for the manufacturing of the fixed-dose combination of G/P anywhere in the territory and in India.
Geographical scope for sale Allows sale in 95 countries accounting for 47.5% of the HCV burden worldwide.
Sales outside the licensed territory Sales outside the Territory are permitted if no granted patent is being infringed. This includes cases in which a compulsory licence is issued.
Non-Territory Purchasers NGOs, UN-related orgs, other not-for-profits, and funding mechanisms such as PEPFAR, Unitaid, USAID, Global Fund, and others based outside the Territory are eligible to procure generic G/P for use in countries within the Territory.
Royalties The licence is royalty-free.
Quality assurance Sublicensees must meet WHO pre-qualification standards or the standards of any stringent regulatory authority as defined by the WHO, or, where such approvals are not yet available, must gain temporary approval by WHO Expert Review Panel.
Data exclusivity AbbVie agrees to provide waivers of data exclusivity in countries with such form of protection, thus facilitating regulatory approval of generics. Sublicensees agree not to seek further regulatory exclusivity.
Patent disclosure The licence discloses the list of pending and granted patents in the Territory and in India at the time of licence execution.
Registration assistance AbbVie will provide, upon MPP request, a copy of clinical data and all non-commercial and non-manufacturing documents to facilitate product registration.
Patent challenges No restrictions on sublicensee patent challenges.
Country List
Afghanistan, Angola, Antigua and Barbuda, Bangladesh, Belize, Benin, Bhutan, Bolivia, Botswana, Burkina Faso, Burundi, Cambodia, Cameroon, Cape Verde, Central African Republic, Chad, Comoros, Congo, Cook Island, Côte d’Ivoire, Democratic Republic of the Congo, Djibouti, Dominica, Egypt, Equatorial Guinea, Eritrea, Ethiopia, Fiji, Gabon, Gambia, Georgia, Ghana, Grenada, Guadeloupe, Guinea, Guinea-Bissau, Guyana, Haiti, Indonesia, Jordan, Kenya, Kiribati, Laos, Lesotho, Liberia, Libya, Madagascar, Malawi, Maldives, Mali, Marshall Islands, Mauritania, Mauritius, Micronesia, Morocco, Mozambique, Myanmar, Namibia, Nauru, Nepal, Niger, Nigeria, Niue, Pakistan, Palau, Papua New Guinea, Philippines, Rep., Reunion Islands, Rwanda, Saba, Saint Eustatius, 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, Suriname, Swaziland, Tanzania, Timor-Leste, Togo, Tunisia, Turkmenistan, Tuvalu, Uganda, Vanuatu, Vietnam, West Bank & Gaza, Yemen, Zambia, Zimbabwe

The MPP invites Expression of Interest (EoI) from potential sublicensees based anywhere in the covered territory and in India for sublicences to manufacture and sell glecaprevir/pibrentasvir:

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