Raltegravir is recommended by WHO as a component of third-line antiretroviral treatment regimens. Raltegravir is also commonly referred to as RAL.
Summary
Raltegravir is widely patented in developing countries, including in major countries that manufacture quality-assured antiretroviral drugs (e.g. India). If and when manufacturers develop generic versions of the product, their ability to supply them would probably be limited to the countries covered by licenses.
Patent status
The compound patent on raltegravir is expected to expire in developing countries in or around 2022. According to available information, the patent was granted in Albania, Belarus, China, Colombia, Georgia, India, Indonesia, Kazakhstan, Mexico, Montenegro, Philippines, South Africa, Turkey, Ukraine, Uzbekistan and Viet Nam, and is pending in Brazil.
The patent on the potassium salt version of raltegravir is expected to expire in 2025, and was granted in Belarus, China, Colombia, Georgia, Kazakhstan, Indonesia, Malaysia, Mexico, Mongolia, Morocco, Nicaragua, Pakistan, Philip- pines, South Africa, Tunisia, Turkey, Ukraine and Viet Nam. Patent applications appear to be pending in Albania, Bosnia, Brazil, Ecuador, Egypt, India, Thailand and Tunisia.
Licensing status
The patent holder has granted voluntary licenses on raltegravir to two manufacturers. Detailed terms and conditions of the licenses are not publicly available but the licenses are known to cover sub-Saharan African and low-income countries (a total of approximately 58 countries). A bilateral technology transfer agreement has been signed between the patent holder and a Brazilian company with a license for Brazil.
In February 2015, raltegravir was licensed to the Medicines Patent Pool for pediatric formulations. The license covers 92 countries. The license will facilitate the development of improved child-friendly formulations of raltegravir, which were identified as a priority by WHO.
Combinations
Raltegravir is available in combination with lamivudine from the original pharmaceutical company, that developed the drug. There are no quality-assured generics of this combination as yet.