Vortioxetine reaches the end of NCE term

Executive Summary

Takeda’s Trintellix (vortioxetine hydrobromide) 5mg, 10mg and 20mg tablets lose their US new chemical entity (NCE) data exclusivity at the end of September 2018. Trintellix, first approved in September 2013 as Brintellix for treating acute major depressive disorder (MDD) in the US, is the first treatment for MDD approved by the US Food and Drug Administration (FDA). The brand-name change to Trintellix came into effect in May 2016 to decrease the risk of prescribing and dispensing errors due to name confusion with AstraZeneca’s antiplatelet drug Brilinta (ticagrelor).