Nintedanib
As of the edition of 20 October 2026, Nintedanib is a small molecule: marketed, first approved in 2014 (US); acts on FGFR1, FGFR2 and FGFR3 and 6 more; US protection ends in 2027.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2015
- Kind
- Small molecule
- Brand name
- Ofev
- First approved
- 15 October 2014 (US)
- Approvals on record
- 11 in 5 regions
- Holder of the most recent approval
- Boehringer Ingelheim; 2 holders in all
- Registered trials
- 165, 21 stopped early
- Disease areas
- Lungs and airways; Cancer; Urinary and reproductive; Digestive system; Pregnancy and women's health; Hormones
US protection
US protection ends in 2027.
The last listed US exclusivity ends in 2027. The application that gives this date is held by Boehringer Ingelheim.
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 product6 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
9 company-target rows on route B because of this drug.
Companies on route B for this drug
In the product9 company-target rows are on route B because of Nintedanib.
See the 9 company-target rows on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Targets
| Gene | Protein | UniProt |
|---|---|---|
| PDGFRB | Platelet-derived growth factor receptor beta | P09619 |
| FGFR1 | Fibroblast growth factor receptor 1 | P11362 |
| PDGFRA | Platelet-derived growth factor receptor alpha | P16234 |
| FLT1 | Vascular endothelial growth factor receptor 1 | P17948 |
| FGFR2 | Fibroblast growth factor receptor 2 | P21802 |
| FGFR4 | Fibroblast growth factor receptor 4 | P22455 |
| FGFR3 | Fibroblast growth factor receptor 3 | P22607 |
| FLT4 | Vascular endothelial growth factor receptor 3 | P35916 |
| KDR | Vascular endothelial growth factor receptor 2 | P35968 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 27 | 16 | 2 | 3 |
| Phase 1 | 51 | 45 | 2 | 4 |
| Phase 2 | 56 | 34 | 6 | 11 |
| Phase 3 | 23 | 17 | 2 | 2 |
| Phase 4 | 8 | 6 | 1 | 1 |
| All trials | 165 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Boehringer Ingelheim | Originator and Lead sponsor of trials | 2014 to now |