Emtricitabine is recommended by WHO as a component of first-line antiretroviral treatment regimens and as an alternative in second-line regimens for adults. It is also an alternative component in first- and second-line regimens for children. It is generally considered to be interchangeable with lamivudine. Emtricitabine is also commonly known as FTC.
Given the expiry of the compound patent on emtricitabine, and covenants not to sue that cover certain secondary patents, there is already strong market competition for antiretroviral regimens containing emtricitabine. Nevertheless, patents on the combinations (or on any of the other individual antiretroviral drugs in those combinations) may delay market competition for combinations containing emtricitabine, in countries not covered by the licenses.
The compound patent on emtricitabine expired in 2010. Other patents have also expired and are therefore no longer in force in most developing countries. However, patents on combinations containing emtricitabine remain in force in many jurisdictions.
The patent holder has issued “covenants not to sue” on emtricitabine with a geographical scope of 112 countries. The covenant not to sue granted through the Medicines Patent Pool is publicly available.
The following fixed-dose combinations include emtricitabine: TDF/FTC, TDF/FTC/EFV, TDF/FTC/RPV and TDF/FTC/EVG/COBI. Patents and patent applications on some of these combinations have been filed (and in a few cases granted) in several developing countries.