Tenofovir alafenamide – TAF

Tenofovir alafenamide is a pro-drug of tenofovir, which has been submitted for regulatory approval in combination with emtricitabine and as part of a single-tablet regimen comprising TAF/FTC/EVG/ COBI. Tenofovir alafenamide is commonly known as TAF.

Summary

Patents on tenofovir alafenamide have been granted in many of the countries currently producing quality-assured antiretrovirals (e.g. China, India, South Africa) and are pending in others (e.g. Brazil). If and when tenofovir alafenamide is approved, market competition is likely to occur in countries covered by the Medicines Patent Pool license.

Patent status

The compound patent on tenofovir was filed by the Czech Academy of Science in 1985 and has expired in most (if not all) jurisdictions where it was granted.

The patent on this tenofovir pro-drug is expected to expire in 2021. The patent has been granted in ARIPO member countries, China, India, Indonesia, Mexico, OAPI member countries, South Africa, Ukraine and Viet Nam and, according to the information that is currently available, is pending in Albania, Brazil and Turkey.

Licensing status

In July 2014, tenofovir alafenamide was licensed to the Medicines Patent Pool. The license covers 112 countries. Separately, bilateral agreements were also announced with two manufacturers. Several generic manufacturers are currently working on the development of tenofovir alafenamide.

Combinations

Tenofovir alafenamide has been developed (and has been filed for regulatory approval) in combination with emtricitabine (FTC) and as part of a single tablet regimen comprising TAF/FTC/EVG/COBI. A combination with FTC/DRV/COBI is also under development.

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