NDAORALTABLETPriority Review
Approved
Oct 2019
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
1
Mechanism of Action
(including F508del-CFTR) to increase the amount of CFTR protein delivered to the cell surface compared to either molecule alone. Ivacaftor potentiates the channel open probability (or gating) of the CFTR protein at the cell surface. The combined effect of elexacaftor, tezacaftor and ivacaftor is…
Clinical Trials (1)
An Efficacy and Safety Study of Ivacaftor in Patients With Cystic Fibrosis and Two Splicing Mutations
Started Nov 2016
2 enrolled
Cystic Fibrosis
Loss of Exclusivity
LOE Date
Jul 17, 2038
150 months away
Patent Expiry
Jul 17, 2038
Exclusivity Expiry
Dec 20, 2031