Ruxolitinib
As of the edition of 20 October 2026, Ruxolitinib is a small molecule: marketed, first approved in 2011 (US); acts on JAK1 and JAK2; US protection ends in 2029.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2014
- Kind
- Small molecule
- Brand name
- Jakafi
- First approved
- 16 November 2011 (US)
- Approvals on record
- 24 in 4 regions
- Holder of the most recent approval
- Incyte; 5 holders in all
- Registered trials
- 412, 65 stopped early
- Disease areas
- Blood and lymph; Cancer; Immune system; Skin and connective tissue; Lungs and airways; Infections
US protection
US protection ends in 2029.
The last listed US exclusivity ends in 2029.
SUN Pharmaceutical Industries holds a later exclusivity on its own new formulation or combination product, ending 2044; it does not protect the original drug.
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 product86 listings count towards this date. The exact date and each listing are in the product.
Companies that need a new molecule because of this drug
4 company-target rows on route B because of this drug.
Companies on route B for this drug
In the product4 company-target rows are on route B because of Ruxolitinib.
Targets
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 25 | 3 | 8 | 3 |
| Phase 1 | 88 | 37 | 38 | 12 |
| Phase 2 | 227 | 96 | 79 | 39 |
| Phase 3 | 58 | 26 | 19 | 10 |
| Phase 4 | 14 | 2 | 6 | 1 |
| All trials | 412 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Incyte | Originator, Later holder and Lead sponsor of trials | 2011 to now |
| Novartis | Applicant and Lead sponsor of trials | 2012 to now |
| SUN Pharmaceutical Industries | Later holder and Lead sponsor of trials | 2019 to now |