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GLECAPREVIR/PIBRENTASVIR (G/P)

En novembre 2018, le MPP a signé un accord de licence non soumis à redevance pour le glécaprévir/pibrentasvir (G/P), un traitement recommandé par l’Organisation mondiale de la Santé (OMS) pour les personnes atteintes d’hépatite C chronique (VHC). Cette licence permettra à des fabricants de médicaments de qualité garantie de produire et de vendre à prix abordable des médicaments génériques contenant du G/P dans 96 pays à revenu faible et intermédiaire, intensifiant ainsi le traitement de la maladie en ouvrant l’accès aux médicaments pangénotypiques les plus efficaces.

Caractéristiques clés
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.

Voir la licence concernée

Liste des pays
Afghanistan, Afrique du Sud, Angola, Antigua-et-Barbuda, Bangladesh, Belize, Benin, Bhoutan, Bolivie, Botswana, Burkina Faso, Burundi, Cambodge, Cameroun, Cap Vert, Chad, Cisjordanie et Gaza, Comores, Congo, Cook Island, Côte d’Ivoire, Djibouti, Dominique, Egypte, Erythrée, Ethiopie, Fidji, Gabon, Gambie, Georgie, Ghana, Grenade, Guinée, Guinée Equatoriale, Guinée-Bissau, Guyana, Haiti, Iles Marshall, Iles Salomon, Indonésie, Jordanie, Kenya, Kiribati, Laos, Lesotho, Liberia, Libye, Madagascar, Malawi, Maldives, Mali, Maroc, Mauritanie, Mauritius, Micronésie, Mozambique, Myanmar, Namibie, Nauru, Nepal, Niger, Nigeria, Niue, Pakistan, Palaos, Papouasie Nouvelle Guinée, Philippines, Rep., République Centrafricaine, République Démocratique du Congo, Rwanda, Saint-Christophe-et-Niévès, Saint-Vincent-et-les-Grenadines, Sainte Lucie, Samoa, Sao Tomé-et-Principe, Senegal, Seychelles, Sierra Leone, Somalie, Soudan, Sri Lanka, Sud Soudan, Suriname, Swaziland, Tanzania, Tchad, Timor-Leste, Togo, Tunisia, Turkmenistan, Tuvalu, Uganda, Vanuatu, Vietnam, West Bank & Gaza, Yemen, Zambia, Zambie, Zimbabwe
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