ORKAMBI

Peak

lumacaftor and ivacaftor

NDAORALTABLETPriority Review
Approved
Jul 2015
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
7

Mechanism of Action

Chloride Channel Activation Potentiators

Pharmacologic Class:

Cystic Fibrosis Transmembrane Conductance Regulator Potentiator

Clinical Trials (5)

NCT03795363N/ACompleted

Orkambi Treatment in 2 to 5 Year Old Children With CF

Started Apr 2019
28 enrolled
Cystic Fibrosis
NCT03859531N/AUnknown

Gastrointestinal Study at Orkambi Therapy in CF Patients

Started Feb 2019
20 enrolled
Cystic Fibrosis
NCT03783286N/ACompleted

Ivacaftor Treatment in 4 Month to 2 Year Old CF Subjects

Started Feb 2019
15 enrolled
Cystic Fibrosis
NCT03659214N/ACompleted

Impact of the Introduction of ORKAMBI on Anxiety, Depression, Quality of Life and Adherence of Adolescents and Young Adults

Started Dec 2017
Cystic Fibrosis
NCT03474042Phase 2Completed

GLPG2737 on Top of Orkambi in Subjects With Cystic Fibrosis

Started Nov 2017
22 enrolled
Cystic Fibrosis

Loss of Exclusivity

LOE Date
Jun 11, 2031
64 months away
Patent Expiry
Jun 11, 2031

Patent Records (5)

Patent #ExpiryTypeUse Code
7973038
Nov 8, 2026
U-1973
8741933
Nov 8, 2026
U-1717
9216969
Nov 8, 2026
SubstanceProduct
8410274
Dec 28, 2026
Product
9670163
Dec 28, 2026
Product
U-1911