Efavirenz is recommended by WHO as a component of first-line antiretroviral treatment regimens for adults, and as a component of first- and second-line treatment regimens for children over three years of age. Efavirenz is also commonly known as EFV.
Summary
The compound patent on efavirenz was in force in several countries, and expired in most countries in 2013. Several quality-assured generic versions of the drug are on the market and, with few exceptions, there should be no intellectual property-related constraints to market competition for efavirenz, as a single agent. Patents and patent applications on TDF/FTC/EFV may delay market competition for this combination in countries not included in the license.
Patent status
The compound patent on efavirenz expired in or around August 2013, in most countries. There are some exceptions where it is expected to expire later, as a result of patent term extensions (for instance, expiry in Ukraine is expected in 2018). According to available information, this patent remains in force in Argentina (process patent only), Dominican Republic, and Ukraine (patent extension beyond 20 years).
Licensing status
A number of South African manufacturers have obtained a license for production of efavirenz in South Africa and for sale to 10 neighboring countries. Compulsory licenses on efavirenz have been issued in Brazil, Indonesia and Thailand.
Combinations
Combinations of efavirenz with TDF/FTC and with TDF/3TC have been developed and are recommended by WHO as preferred first-line regimens. Bristol-Myers Squibb and Gilead Sciences jointly own patents, and patent applications on the combination of efavirenz with TDF/FTC, which have been granted in China, EAPO member states, Mexico, South Africa and Turkey, are also pending in Argentina, Brazil, India and Venezuela. The Medicines Patent Pool license on TDF includes a covenant not to sue, which covers this combination for the 112 countries included in the license.