In July 2022, ViiV Healthcare and the Medicines Patent Pool (MPP) signed a voluntary licensing agreement for patents related to cabotegravir long-acting (LA) for HIV pre-exposure prophylaxis (PrEP), enabling access in 90 countries. In July 2025, this licence was expanded to also cover the use of cabotegravir LA for HIV treatment (in combination with rilpivirine) in the same 90 countries. 

The agreement enables generic manufacturers to develop, manufacture and supply generic versions of cabotegravir LA for for PrEP and treatment in all low-income, lower-middle-income and Sub-Sahara African countries, as well as others where there are no patents in force.  

This is the first voluntary licence covering a full long-acting HIV treatment regimen, marking a major milestone in global access to innovative HIV medicines.  

Subject to required regulatory approvals being obtained, the updated agreement is expected to accelerate access to generic cabotegravir LA for both prevention and treatment.  

*Please note this page appears twice: under “HIV” and “Long-acting therapeutics” 

Key Features
Eligibility for sublicences Sublicences can be issued to any qualified entity worldwide. The number of sublicensees is up to three, with a possibility to have additional sublicensees if the evidence demonstrates a public health need for it. 
Manufacturing Allows manufacturing of cabotegravir anywhere in the world in the form of a tablet containing 30 mg of cabotegravir as its sole active pharmaceutical ingredient; and/or an extended-release injectable suspension form containing cabotegravir. 
Geographical scope for sale Allows for sale of cabotegravir in all low-income countries, lower middle-income countries, sub-Saharan African countries, least-developed countries (as defined by the UN), as well as countries where ViiV does not have patent rights for cabotegravir. 
Sales outside the licensed territory Nothing in this Agreement shall be construed to prevent the Licensee from undertaking any activity anywhere in the world where such activity is (1) outside the scope of the Patent Rights or (2) is permitted pursuant to a compulsory licence of the Patent Rights. 
Royalties The licence is royalty free for most countries within the Territory for both private and public market. It is royalty-bearing for 10 countries where ViiV holds patent rights (i.e. Algeria, Egypt, India, Indonesia, Kyrgyzstan, Morocco, Philippines, Tajikistan, Ukraine, Vietnam). In those royalty countries the rate is 5% of net sales of the product in the public market and 10% royalty in the private market. 
Quality assurance Licensees must obtain World Health Organization (WHO) Pre-qualification (PQ), or approval from a Stringent Regulatory Authority (SRA) or a WHO-Listed Authority (WLA). Where such approval is not yet available, provisional or emergency use authorisations available through WHO or an SRA may be obtained. 
Data exclusivity Data exclusivity is waived in countries of the Territory with such form of protection, thus facilitating regulatory approval of generics. 
Patent disclosure The licence discloses the list of PCT patent applications at the time of licence signing. 

 

Country List
Afghanistan, Algeria, Angola, Bangladesh, Benin, Bhutan, Bolivia (Plurinational State of), Botswana, Burkina Faso, Burundi, Cabo Verde, Cambodia, Cameroon, Central African Republic, Chad, Comoros, Congo, democratic Republic of the, Congo, Côte d'Ivoire, Djibouti, Egypt, El Salvador, Equatorial Guinea, Eritrea, Eswatini, Ethiopia, Gabon, Gambia (the), Ghana, Guinea, Guinea-Bissau, Haiti, Honduras, India, Indonesia, Iran (Islamic Republic of), Kenya, Kiribati, Korea (Democratic People's Republic of), Kyrgyzstan, Lao People's Democratic Republic (the), Lebanon, Lesotho, Liberia, Madagascar, Malawi, Mali, Mauritania, Mauritius, Micronesia (Federated States of), Mongolia, Morocco, Mozambique, Myanmar, Namibia, Nepal, Nicaragua, Niger, Nigeria, Pakistan, Papua New Guinea, Philippines, Rwanda, Samoa, Sao Tome and Principe, Senegal, Seychelles, Sierra Leone, Solomon Islands, Somalia, South Africa, South Sudan, Sri Lanka, Sudan, Syrian Arab Republic, Tajikistan, Tanzania, United Republic of, Timor-Leste, Togo, Tunisia, Tuvalu, Uganda, Ukraine, Uzbekistan, Vanuatu, Viet Nam, West Bank and Gaza, Yemen, Zambia, Zimbabwe

GENERIC PARTNERS AND PRODUCT DEVELOPERS