Atazanavir (boosted with ritonavir) is recommended by WHO as a component of second-line antiretroviral treatment regimens in adults. Atazanavir is also known as ATV.
Summary
The market competition for atazanavir is likely to increase in countries covered by the Medicines Patent Pool (MPP) license or in countries where there are no patents in force. In countries outside the scope of the MPP license and in which there are patents on atazanavir, market competition may be delayed until patent expiry. Patents on ritonavir will also probably affect the sale of atazanavir/ritonavir in certain jurisdictions.
Patent status
The compound patent on atazanavir is exclusively licensed to Bristol-Myers Squibb by Novartis. Its expected expiry date is 2017. According to available information, the compound patent is currently in force in the following low- or middle-income countries: Argentina, Brazil, China, Malaysia, Mexico, Pakistan, Philippines and South Africa. The patent application is pending in India and Thailand.
The patent on the bisulfate salt is also relevant to the production of atazanavir. Its expected expiry date is 2018, and it has been granted in the following low- or middle-income countries: Argentina, China, Egypt, Georgia, Indonesia, Malaysia, Mexico, Pakistan, Peru, Philippines, South Africa, Thailand, Turkey and Ukraine.
Licensing status
In December 2013, atazanavir was licensed to the Medicines Patent Pool. The license has a geographical scope of 110 countries. It contains provisions that do not impede sale to additional countries where there is no infringement of patents on atazanavir, under certain circumstances.
So far, the licence has been sublicensed to four companies. Prior to the licence agreement with the MPP, immunity from suit agreements was in place with three generic manufacturers, with a geographical scope comprising sub-Saharan Africa and India (50 countries). A bilateral technology transfer agreement has been signed between the patent holder and a Brazilian company, with a licence for production and sale in Brazil.
Combinations
There are two fixed-dose combinations containing atazanavir that currently have regulatory approval:
1) atazanavir/ritonavir (also known as ATV/r), for which there are currently two quality-assured manufacturers, and
2) atazanavir/cobicistat (also known as ATV/c), which is currently only available from the originator company.