Key Features
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. |
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
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
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
Additional Information
Additional Information
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
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