Etravirine is recommended by WHO as a component of third-line antiretroviral treatment regimens. Etravirine is also commonly known as ETV.
Summary
There are no pharmaceutical companies manufacturing generic etravirine. Given the patent coverage in key manufacturing countries, it is likely that a license would be required to manufacture the drug. Etravirine is widely patented in low-income countries.
Patent status
The compound patent on etravirine is expected to expire in 2019. The patent has been granted in Argentina, ARIPO member countries, Brazil, China, EAPO member countries, India, Indonesia Malaysia, Mexico, OAPI member countries, Philippines, South Africa, Sri Lanka, Thailand, Turkey, Ukraine and Viet Nam, and appears to be pending in Pakistan.
Patents on the pill form of etravirine, expiring in 2020, have been granted in ARIPO member countries, China, EAPO member countries, India, Indonesia, Mexico, OAPI member countries, South Arica and Ukraine, and are pending in Brazil, Turkey and Viet Nam.
Licensing status
There are currently no voluntary licenses to manufacture generic etravirine. There is a distribution and packaging agreement with one company for sub-Saharan Africa.
Combinations
There are no fixed-dose combinations containing etravirine on the market.