AbbVie generic LPV/r manufacturing agreement

Partnership objective

Address future demands for HIV treatment Lopinavir/Ritonavir (LPV/r) in South Africa and across Africa, by increasing the number of manufacturers and suppliers.

Upon obtaining a sublicense from MPP, the agreement allows generic ARV manufacturers to manufacture and sell generic versions of LPV/r throughout Africa. Upon obtaining a sublicense from MPP, the agreement allows generic ARV manufacturers to manufacture and sell generic versions of LPV/r throughout Africa. Copyright AbbVie

Description of partnership activities and how they address needs and challenges

Africa accounts for approximately 90% of the total usage of LPV/r in donor-funded developing countries. The Medicines Patent Pool (MPP) and AbbVie signed a new licensing agreement to help ensure sustainability of long-term supply of LPV/r, the most widely used second-line HIV treatment in South Africa and across Africa. Upon obtaining a sublicense from MPP, the agreement allows generic ARV manufacturers to manufacture and sell generic versions of LPV/r throughout Africa, as well as combinations of ritonavir with other ARVs, such as atazanavir and darunavir, as alternative second-line treatments.

The MPP will work to swiftly grant licences to generic manufacturers with stringent regulatory approval.  Those that have already received regulatory approval for these medicines in South Africa will be able to distribute in the country. The South African government will consider applications from other manufacturers that wish to seek approval under its fast track process. By doing so, it will aim to secure supply of the product as treatment needs increase, as well as to support the Ministry of Health in providing care for communities living with HIV.

The agreement  also allow global manufacturers to supply LPV/r and other ritonavir-based combinations to the whole African continent. While many African countries are currently able to purchase generic versions of these medicines from India, this license will enable manufacturers in other countries where there are patents, such as China and South Africa, to manufacture LPV/r and other ritonavir-based treatments, thus broadening the supplier base for the entire African continent.

The licence is royalty free and, as is the case for all MPP licences, is non-exclusive and published on the MPP website.  The agreement represents the second licence established between MPP and AbbVie. The first agreement was for paediatric formulations of LPV/r signed in December 2014. More information are available here

Partnership information

Company(ies) AbbVie

Partner(s) Medicines Patent Pool, South Africa Ministry of Health

Type of Partner(s) Government, NGOs

Therapeutic Focus Infectious Diseases

Disease(s) HIV/AIDS

Program Type(s) Availability of Treatment - Financial Support, Research & Development - Development of Treatments

Targeted Population(s) Patients in needs of treatment

Region(s) Middle East & North Africa, Sub-Saharan Africa

Number of Countries 68

Country(ies) Algeria, Angola, Bahrain, Benin, Botswana, Burkina Faso, Burundi, Cameroon, Cape Verde, Central African Republic, Chad, Comoros, Congo, Côte d'Ivoire, Democratic Republic of the Congo, Djibouti, Egypt, Equatorial Guinea, Eritrea, Ethiopia, Gabon, Ghana, Guinea, Guinea-Bissau, Iran, Iraq, Israel, Jordan, Kenya, Kuwait, Lebanon, Lesotho, Liberia, Libya, Madagascar, Malawi, Mali, Mauritania, Mauritius, Morocco, Mozambique, Namibia, Niger, Nigeria, Oman, Qatar, Rwanda, Sao Tome and Principe, Saudi Arabia, Senegal, Seychelles, Sierra Leone, Somalia, South Africa, South Sudan, Sudan, Swaziland, Syria, Tanzania, The Gambia, Togo, Tunisia, Uganda, United Arab Emirates, West Bank and Gaza, Yemen, Zambia, Zimbabwe

Start Date 2015

More information Press Release

Anticipated completion date Ongoing

« Is of the utmost importance that patients have continuous access to these critical therapies. This agreement will help to address long-term and sustainable access to ARV treatments and meet the increasing demand for treatment in Africa »

Mike Severino, Executive Vice President, Research and Development and Chief Scientific Officer of AbbVie