Alectinib
As of the edition of 20 October 2026, Alectinib is a small molecule: marketed, first approved in 2014 (JP); acts on ALK and RET; US protection ends in 2031.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2017
- Kind
- Small molecule
- Brand name
- Alecensa
- First approved
- 4 July 2014 (JP)
- Approvals on record
- 8 in 5 regions
- Holder of the most recent approval
- Roche; 4 holders in all
- Registered trials
- 68, 6 stopped early
- Disease areas
- Cancer; Lungs and airways; Digestive system; Blood and lymph; Hormones; Urinary and reproductive
US protection
US protection ends in 2031.
The last listed US drug-substance patent ends in 2031. The application that gives this date is held by Roche.
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 product3 listings count towards this date. The exact date and each listing are in the product.
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Companies that need a new molecule because of this drug
1 company-target row on route B because of this drug.
Companies on route B for this drug
In the product1 company-target row is on route B because of Alectinib.
See the 1 company-target row on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Targets
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 13 | 6 | 5 | 0 |
| Phase 1 | 9 | 7 | 1 | 1 |
| Phase 2 | 33 | 10 | 17 | 5 |
| Phase 3 | 12 | 5 | 7 | 0 |
| Phase 4 | 1 | 0 | 1 | 0 |
| All trials | 68 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Roche | Applicant and Lead sponsor of trials | 2013 to now |