Neratinib
As of the edition of 20 October 2026, Neratinib is a small molecule: marketed, first approved in 2017 (US); acts on EGFR; US protection ends in 2030.
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
- Nerlynx
- First approved
- 17 July 2017 (US)
- Approvals on record
- 2 in 2 regions
- Holder of the most recent approval
- Pierre Fabre; 2 holders in all
- Registered trials
- 91, 13 stopped early
- Disease areas
- Cancer; Skin and connective tissue; Digestive system; Nervous system; Hormones; Urinary and reproductive
US protection
US protection ends in 2030.
The last listed US drug-substance patent ends in 2030. The application that gives this date is held by Puma Biotechnology.
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 product1 listing counts 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
2 companies on route B because of this drug.
Companies on route B for this drug
In the product2 companies are on route B because of Neratinib.
See the 2 companies on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| EGFR | Epidermal growth factor receptor | P00533 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 7 | 2 | 3 | 0 |
| Phase 1 | 26 | 18 | 4 | 4 |
| Phase 2 | 54 | 18 | 19 | 9 |
| Phase 3 | 4 | 2 | 2 | 0 |
| All trials | 91 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Puma Biotechnology | Originator and Lead sponsor of trials | 2003 to now |
| Pierre Fabre | Applicant and Lead sponsor of trials | 2018 to now |