Afatinib
As of the edition of 20 October 2026, Afatinib is a small molecule: marketed, first approved in 2013 (US); acts on EGFR; 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
- Gilotrif
- First approved
- 12 July 2013 (US)
- Approvals on record
- 9 in 5 regions
- Holder of the most recent approval
- Boehringer Ingelheim; 2 holders in all
- Registered trials
- 210, 28 stopped early
- Disease areas
- Cancer; Lungs and airways; Digestive system; Skin and connective tissue; Urinary and reproductive; Hormones
US protection
US protection ends in 2029.
The last listed US drug-substance patent ends in 2029. 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
1 company on route B because of this drug.
Companies on route B for this drug
In the product1 company is on route B because of Afatinib.
See the 1 company 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 | 23 | 13 | 1 | 0 |
| Phase 1 | 54 | 40 | 4 | 7 |
| Phase 2 | 110 | 53 | 18 | 18 |
| Phase 3 | 17 | 14 | 1 | 2 |
| Phase 4 | 6 | 2 | 1 | 1 |
| All trials | 210 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Boehringer Ingelheim | Originator and Lead sponsor of trials | 2013 to now |