In November 2021, Pfizer and the Medicines Patent Pool signed a licence agreement to facilitate affordable access of Pfizer’s oral COVID-19 antiviral treatment nirmatrelvir in combination with low dose ritonavir in 95 countries.

Nirmatrelvir in combination with low dose ritonavir is strongly recommended by the World Health Organization for mild and moderate COVID-19 patients at highest risk of hospital admission. These include unvaccinated, older, or immunosuppressed patients.

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 formulations of nirmatrelvir anywhere in the world.
Geographical scope for sale Allows for sale of nirmatrelvir in 95 countries. For South Africa, the sales are allowed only in public market.
Sales outside the licensed territory Nothing in this Agreement shall be construed to prevent the Licensee from engaging in activities inside or outside the Territory where such activities would not (1) infringe the Patents and/or any other intellectual property rights; and/or (2) use or misappropriate Licensed Know-How ; and/or use or require the use of any of Pfizer’s Confidential Information, including where a compulsory licence has been issued.
Royalties The licence is royalty free during the WHO Public Health Emergency of International Concern (PHEIC). After the PHEIC ends, royalties are 5% of net sales for sales to governmental authorities or Public Purchasers, and 10% of net sales for commercial entities. Pfizer will not collect royalties on sales to low-income countries or on sales of product made and sold in countries within the licensed territory where the product is not patented and does not benefit from regulatory exclusivity.
Quality assurance Licensees must obtain approval from the World Health Organization (WHO) Pre-qualification (WHO-PQ), or a Stringent Regulatory Authority (SRA). 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 to MPP and the Licensee the list of patent applications worldwide at the time of licence signing.

 

Country List
Afghanistan, Algeria, Angola, Armenia, Bangladesh, Belize, 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), Georgia, Ghana, Guatemala, Guinea, Guinea-Bissau, Haiti, Honduras, India, Indonesia, Iran (Islamic Republic of), Jordan, Kenya, Kiribati, Korea (Democratic People's Republic of), Kosovo, Kyrgyzstan, Lao People's Democratic Republic (the), Lesotho, Liberia, Madagascar, Malawi, Mali, Mauritania, Micronesia (Federated States of), Moldova, Republic of, Mongolia, Morocco, Mozambique, Myanmar, Namibia, Nepal, Nicaragua, Niger, Nigeria, Pakistan, Papua New Guinea, Philippines, Rwanda, Samoa, Sao Tome and Principe, Senegal, Sierra Leone, Solomon Islands, Somalia, South Africa, South Sudan, Sri Lanka, State of Palestine, Sudan, Syrian Arab Republic, Tajikistan, Tanzania, United Republic of, Timor-Leste, Togo, Tonga, Tunisia, Uganda, Ukraine, Uzbekistan, Vanuatu, Venezuela (Bolivarian Republic of), Viet Nam, Yemen, Zambia, Zimbabwe

Technology transfer pack

Please find below the list of generic manufacturers who requested the technology transfer pack for nirmatrelvir:

Company name:
Amneal
Apeloa
Aurobindo
Biocon
Cadila Pharmaceuticals Ltd.
Celltrion
Cipla
Darnitsa
Divi’s
DongBang
Emcure
FHI Zdravlje
Fosun
Glenmark Lifesciences
Glenmark Pharma
Granules
Hetero Labs Limited
Hikma Pharmaceuticals
Jiuzhou
Laurus
Macleods
Magnachem
MSN
Mylan
Neolpharma
Remington
SMS Pharma
Sun Pharmaceutical Industries Ltd.
Torrent

Appendix 3

Territory

LIC : Low-Income Country

LMIC : Lower Middle-Income Country

UMIC : Upper Middle-Income Country

 

Country Classification

Afghanistan LIC

Algeria LMIC

Angola LMIC

Armenia UMIC

Bangladesh LMIC

Belize UMIC

Benin LMIC

Bhutan LMIC

Bolivia LMIC

Botswana UMIC

Burkina Faso LIC

Burundi LIC

Cabo Verde LMIC

Cambodia LMIC

Cameroon LMIC

Central African Republic LIC

Chad LIC

Comoros LMIC

Congo, Dem. Rep. LIC

Congo, Rep. LMIC

Côte d’Ivoire LMIC

Djibouti LMIC

Egypt, Arab Rep. LMIC

El Salvador LMIC

Equatorial Guinea UMIC

Eritrea LIC

Eswatini LMIC

Ethiopia LIC

Gabon UMIC

Gambia, The LIC

Georgia UMIC

Ghana LMIC

Country Classification

Guatemala UMIC

Guinea LIC

Guinea-Bissau LIC

Haiti LIC

Honduras LMIC

India LMIC

Indonesia UMIC

Iran UMIC

Jordan UMIC

Kenya LMIC

Kiribati LMIC

Korea, Dem. People’s Rep. LIC

Kosovo UMIC

Kyrgyz Republic LMIC

Lao PDR LMIC

Lesotho LMIC

Liberia LIC

Madagascar LIC

Malawi LIC

Mali LIC

Mauritania LMIC

Micronesia, Fed. Sts. LMIC

Moldova LMIC

Mongolia LMIC

Morocco LMIC

Mozambique LIC

Myanmar LMIC

Namibia UMIC

Nepal LMIC

Nicaragua LMIC

Niger LIC

Nigeria LMIC

Pakistan LMIC

Papua New Guinea LMIC

Philippines LMIC

Rwanda LIC

Samoa UMIC

São Tomé & Principe LMIC

Senegal LMIC

Sierra Leone LIC

Country Classification

Solomon Islands LMIC

Somalia LIC

South Africa (Public Market) UMIC

South Sudan LIC

Sri Lanka LMIC

Sudan LIC

Syrian Arab Republic LIC

Tajikistan LIC

Tanzania LMIC

Timor-Leste LMIC

Togo LIC

Tonga UMIC

Tunisia LMIC

Uganda LIC

Ukraine LMIC

Uzbekistan LMIC

Vanuatu LMIC

Venezuela UMIC

Vietnam LMIC

West Bank and Gaza LMIC

Yemen, Rep. LIC

Zambia LMIC

Zimbabwe LMIC

GENERIC PARTNERS AND PRODUCT DEVELOPERS