Progress & Achievements » Licences
LOPINAVIR, RITONAVIR (LPV/r)
In December 2015, the Medicines Patent Pool (MPP) and AbbVie signed a new licensing agreement to increase access to lopinavir, ritonavir (LPV/r), a WHO-recommended second-line treatment, in all 54 African countries.
For more information see MedsPaL
Key Features
| Eligibility for sublicences | Sublicences can be issued to any qualified entity worldwide. | |
| Manufacturing | Allows manufacturing of the active pharmaceutical ingredient and the finished formulation of LPV/r and RTV anywhere in the world. | |
| Geographical scope for sale | Allows for sale of LPV/r and RTV in all African countries. | |
| Sales outside the licensed territory |
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| Royalties | The licence 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 LPV/r or RTV 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 pending and granted patents on LPV/r and RTV worldwide. | |
| Additional flexibilities for licensees | Licensees have the right to challenge the validity of any of the licensed patents. |
Afghanistan, Åland Islands, Albania, Algeria, American Samoa, Andorra, Angola, Anguilla, Antarctica, Antigua and Barbuda, Argentina, Armenia, Aruba, Australia, Austria, Azerbaijan, Bahamas, Bahrain, Bangladesh, Barbados, Belarus, Belgium, Belize, Benin, Bermuda, Bhutan, Bolivia (Plurinational State of), Bosnia and Herzegovina, Botswana, Bouvet Island, Brazil, British Indian Ocean Territory, Virgin Islands (British), Brunei Darussalam, Bulgaria, Burkina Faso, Burundi, Cambodia, Cameroon, Canada, Cabo Verde, Cayman Islands, Central African Republic, Chad, Chile, China, Christmas Island, Cocos (Keeling) Islands, Colombia, Comoros, Cook Islands, Costa Rica, Côte d'Ivoire, Croatia, Cuba, Cyprus, Czechia, Congo, democratic Republic of the, Denmark, Djibouti, Dominica, Dominican Republic, Ecuador, Egypt, El Salvador, Equatorial Guinea, Eritrea, Estonia, Eswatini, Ethiopia, Falkland Islands (Malvinas), Faroe Islands, Fiji, Finland, France, French Guiana, French Polynesia, French Southern Territories, Gabon, Gambia (the), Georgia, Germany, Ghana, Gibraltar, Greece, Greenland, Grenada, Guadeloupe, Guam, Guatemala, Guinea, Guinea-Bissau, Guyana, Haiti, Heard Island and McDonald Islands, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iraq, Ireland, Iran (Islamic Republic of), Isle of Man, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Kiribati, Korea (Democratic People's Republic of), Kosovo, Kuwait, Kyrgyzstan, Lao People's Democratic Republic (the), Latvia, Lebanon, Lesotho, Liberia, Libya, Liechtenstein, Lithuania, Luxembourg, Macao, North Macedonia, Madagascar, Malawi, Malaysia, Maldives, Mali, Malta, Marshall Islands, Martinique, Mauritania, Mauritius, Mayotte, Mexico, Micronesia (Federated States of), Monaco, Mongolia, Montserrat, Morocco, Mozambique, Myanmar, Namibia, Nauru, Nepal, Netherlands, New Caledonia, New Zealand, Nicaragua, Niger, Nigeria, Niue, Norfolk Island, Northern Mariana Islands, Norway, State of Palestine, Oman, Pakistan, Palau, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Pitcairn, Poland, Portugal, Puerto Rico, Qatar, Korea, Republic of, Moldova, Republic of, Congo, Réunion, Romania, Russian Federation, Rwanda, Saint Helena, Ascension and Tristan da Cunha, Saint Kitts and Nevis, Saint Lucia, Saint Vincent and the Grenadines, Saint Pierre and Miquelon, Samoa, San Marino, Sao Tome and Principe, Saudi Arabia, Senegal, Serbia, Montenegro, Seychelles, Sierra Leone, Singapore, Slovakia, Slovenia, Solomon Islands, Somalia, South Africa, South Georgia and the South Sandwich Islands, South Sudan, Spain, Sri Lanka, Sudan, Suriname, Svalbard and Jan Mayen Islands, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Province of China, Tajikistan, Tanzania, United Republic of, Thailand, Timor-Leste, Togo, Tokelau, Tonga, Trinidad and Tobago, Tunisia, Turkey, Turkmenistan, Turks and Caicos Islands, Tuvalu, Virgin Islands (U.S.), Uganda, Ukraine, United Arab Emirates, United Kingdom, United States Minor Outlying Islands, United States of America, Uruguay, Uzbekistan, Vanuatu, Venezuela (Bolivarian Republic of), Viet Nam, Wallis and Futuna Islands, Western Sahara, Yemen, Zambia, Zimbabwe, Holy See
LOPINAVIR, RITONAVIR (LPV/r)
GENERIC PARTNERS AND PRODUCT DEVELOPERS
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