TENOFOVIR DISOPROXIL FUMARATE (TDF)
In July 2011, the Medicines Patent Pool (MPP) signed its first licence with a pharmaceutical company, Gilead Sciences, for tenofovir disoproxil fumarate (TDF), part of the World Health Organization (WHO)-preferred first-line treatment for adults. Additionally, patents on the combination of TDF/FTC and TDF/FTC with efavirenz (EFV), the WHO-recommended first-line regimen for adults, were added to the licence in 2015. The licence covers both treatment and Pre-Exposure Prophylaxis (PrEP), benefiting at least 112 countries.
In September 2017, the two parties amended the agreement to allow for an extension of the Territory for TDF that together are 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 India, China and South Africa.|
|Geographical scope for sale||Allows for sale of TDF in 117 countries home to 90.5% of people living with HIV in low- and middle-income countries (See “Termination or unbundling” below).|
|Sales outside the licensed territory||Sublicensees may supply outside the licensed territory if a country issues a compulsory licence.|
|Royalties||The royalty rate is 3-5% 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 FDA or the European Medicines Agency.|
|Combinations||Sublicensees have the right to combine TDF 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 112 licensed countries.|
|Technology transfer||All Indian and South African sub-licensees benefit from a one-time technology transfer.|
|Termination (or unbundling)||Licensees have the right to terminate the agreement at any time on a product-by-product basis. Four companies have taken the MPP-Gilead licence and terminated the TDF part of the licence to supply additional countries in which TDF is not patented (see “Sublicensees” section).|
Quality assured formulations from MPP generic partners: Tenofovir disoproxil fumarate tablets 300mg, Tenofovir disoproxil fumarate/emtricitabine tablets 300mg/200mg, Tenofovir disoproxil fumarate/emtricitabine/efavirenz tablets 300mg/200mg/600mg, Tenofovir disoproxil fumarate/lamivudine tablets 300mg/300mg, Tenofovir disoproxil fumarate/lamivudine/efavirenz tablets 300mg/300mg/600mg, Tenofovir disoproxil fumarate/lamivudine/dolutegravir 50 mg/300 mg/300 mg