NDAORALTABLETPriority Review
Approved
Feb 2018
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
1
Mechanism of Action
(including F508del-CFTR) to increase the amount of mature CFTR protein delivered to the cell surface. Ivacaftor is a CFTR potentiator that facilitates increased chloride transport by potentiating the channel-open probability (or gating) of the CFTR protein at the cell surface. For ivacaftor to…
Indications (2)
Clinical Trials (1)
Study of Ivacaftor in Cystic Fibrosis Subjects 2 Through 5 Years of Age With a CFTR Gating Mutation
Started Jan 2013
35 enrolled
Cystic Fibrosis
Loss of Exclusivity
LOE Date
Apr 14, 2035
110 months away
Patent Expiry
Apr 14, 2035
Exclusivity Expiry
Dec 21, 2027