TENOFOVIR ALAFENAMIDE (TAF)
In July 2014, the Medicines Patent Pool (MPP) signed a licensing agreement with Gilead Sciences for tenofovir alafenamide (TAF), benefiting at least 112 countries. The TAF licence broadened MPP’s collaboration with Gilead and the parties’ earlier licence for the production of tenofovir disoproxil fumarate (TDF), emtricitabine (FTC), cobicistat (COBI), and elvitegravir (EVG).
In September 2017, the two parties amended the agreement to allow for an extension of the territory for TAF to Belarus, Malaysia, Ukraine and Philippines. Together, the extended territory is home to 90.5% of people living with HIV in low- and middle-income countries.
In September 2019, the agreement was amended to allow for the inclusion of Azerbaijan to the territory of now 117 countries for BIC, COBI, TAF and TDF.
| Eligibility for sublicences | Sublicences can be issued to entities based in China, India and South Africa. |
| Manufacturing | Allows manufacturing of active pharmaceutical ingredient and finished formulations in China, India and South Africa. |
| Geographical scope for sale | Allows for sale of TAF in 117 countries representing 90.5% of people living with HIV in low- and middle-income countries. |
| Sales outside the licensed territory | Sublicensees may supply outside the licensed territory if a country issues a compulsory licence. |
| Royalties | The royalty rate is 5% of net sales of finished product. There are no royalties for the sale of the active pharmaceutical ingredient or paediatric formulations. |
| Quality assurance | Licensees must obtain approval from WHO Pre-qualification, the US Food and Drug Administration or the European Medicines Agency. |
| Combinations | Sublicensees have the right to combine TAF 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 all pending and granted patents in the 116 licensed countries, as of September 2017. |
| Technology transfer | All Indian sublicensees benefit from a one-time technology transfer. |
| Additional flexibilities for licensees | Licensees have the right to terminate the agreement at any time on a product-by-product basis and can challenge any of the licensed patents. |
Quality assured formulations from MPP generic partners:
- TAF 25mg
- TAF/FTC 25/200 mg
- TAF/FTC/DTG 25/200/50 mg
- TAF/3TC/DTG 25/300/50 mg
GENERIC PARTNERS AND PRODUCT DEVELOPERS
Click the logos to access the sublicensing agreements:
