Ivacaftor
As of the edition of 20 October 2026, Ivacaftor is a small molecule: marketed, first approved in 2012 (US); acts on CFTR; US protection ends in 2040.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2018
- Kind
- Small molecule
- Brand name
- Kalydeco
- First approved
- 31 January 2012 (US)
- Approvals on record
- 42 in 4 regions
- Holder of the most recent approval
- Vertex; 3 holders in all
- Registered trials
- 151, 11 stopped early
- Disease areas
- Lungs and airways; Inherited and neonatal; Digestive system; Nutrition and metabolism; Hormones; Ear, nose and throat
US protection
US protection ends in 2040.
The last listed US drug-substance patent ends in 2040. The application that gives this date is held by Vertex.
This is the US only, and it is not the date generics or biosimilars can enter.
The exact date and the listings behind it
In the product255 listings count towards this date. The exact date and each listing are in the product.
See the exact date and the 255 listings behind itRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| CFTR | Cystic fibrosis transmembrane conductance regulator | P13569 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 24 | 10 | 6 | 2 |
| Phase 1 | 26 | 22 | 4 | 0 |
| Phase 2 | 28 | 24 | 2 | 2 |
| Phase 3 | 62 | 54 | 5 | 3 |
| Phase 4 | 11 | 4 | 3 | 4 |
| All trials | 151 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Vertex | Originator, Applicant and Lead sponsor of trials | 2012 to now |