DACLATASVIR (DAC)

En novembre 2015, le MPP a annoncé un accord de licence avec Bristol-Myers Squibb couvrant le médicament antiviral à action directe (AAD) daclatasvir (DAC) et ses combinaisons. Le contrat permet la fabrication des médicaments génériques contre l’hépatite C pour sa vente dans au moins 112 pays, qui regroupent 65,4% des personnes vivant avec le VHC dans les pays à revenu faible et intermédiaire.

Caractéristiques clés
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.

Liste des pays
Afghanistan, Afrique du Sud, Algérie, Angola, Azerbaïdjan, Bangladesh, Belize, Benin, Bhoutan, Bolivie, Botswana, Burkina Faso, Burundi, Cambodge, Cameroun, Cap Vert, Cisjordanie et Gaza, Comores, Costa Rica, Côte d’Ivoire, Cuba, Djibouti, Dominique, El Salvador, Equateur, Erythrée, Ethiopie, Fidji, Gabon, Gambie, Georgie, Ghana, Grenade, Guatemala, Guinée, Guinée Equatoriale, Guinée-Bissau, Guyana, Haiti, Honduras, Ile Maurice, Iles Cook, Iles Marshall, Iles Salomon, Inde, Indonésie, Irak, Jamaïque, Kenya, Kiribati, Laos, Lesotho, Liberia, Libye, Madagascar, Malawi, Maldives, Mali, Maroc, Mauritanie, Micronésie, Mongolie, Mozambique, Myanmar, Namibie, Nauru, Nepal, Nicaragua, Niger, Nigeria, Niue, Ouganda, Ouzbékistan, Pakistan, Palaos, Panama, Papouasie Nouvelle Guinée, Paraguay, Philippines, République Centrafricaine, République Démocratique de Corée, République Démocratique du Congo, République Dominicaine, République du Congo, Rwanda, Saint-Vincent-et-les-Grenadines, Sainte Lucie, Salvador, Samoa, Sao Tomé-et-Principe, Senegal, Seychelles, Sierra Leone, Somalie, Soudan, Sri Lanka, St Lucia, St. Vincent and the Grenadines, Sud Soudan, Suriname, Swaziland, Syrie, Tanzania, Tanzanie, Tchad, Timor oriental, Timor-Leste, Togo, Tonga, Tunisia, Tunisie, Turkmenistan, Tuvalu, Uganda, Vanuatu, Vietnam, Yemen, Zambia, Zambie, Zimbabwe

Génériqueurs partenaires et développeurs de produits

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