Erdafitinib
As of the edition of 20 October 2026, Erdafitinib is a small molecule: marketed, first approved in 2019 (US); acts on FGFR1, FGFR2 and FGFR3 and 1 more; US protection ends in 2033.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2025
- Kind
- Small molecule
- Brand name
- Balversa
- First approved
- 12 April 2019 (US)
- Approvals on record
- 9 in 4 regions
- Holder of the most recent approval
- Johnson & Johnson; 4 holders in all
- Registered trials
- 42, 6 stopped early
- Disease areas
- Cancer; Urinary and reproductive; Pregnancy and women's health; Blood and lymph; Immune system; Inherited and neonatal
US protection
US protection ends in 2033.
The last listed US drug-substance patent ends in 2033. The application that gives this date is held by Johnson & Johnson.
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.
See the exact date and the 6 listings behind itRequest access. Nothing is shown until you do.
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 Erdafitinib.
See the 4 company-target rows 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 | 3 | 1 | 0 | 1 |
| Phase 1 | 15 | 11 | 3 | 1 |
| Phase 2 | 21 | 5 | 12 | 4 |
| Phase 3 | 3 | 0 | 3 | 0 |
| All trials | 42 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Johnson & Johnson | Originator, Applicant and Lead sponsor of trials | 2012 to now |