Erlotinib
As of the edition of 20 October 2026, Erlotinib is a small molecule: marketed, first approved in 2004 (US); acts on EGFR; no US protection is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2005
- Kind
- Small molecule
- Brand name
- Tarceva
- First approved
- 18 November 2004 (US)
- Approvals on record
- 6 in 3 regions
- Holder of the most recent approval
- Cheplapharm; 3 holders in all
- Registered trials
- 684, 135 stopped early
- Disease areas
- Cancer; Lungs and airways; Digestive system; Hormones; Urinary and reproductive; Nervous system
US protection
No US protection is listed.
The FDA registers list no drug-substance patent or exclusivity that counts for this drug.
This is the US only.
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 Erlotinib.
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 | 28 | 16 | 2 | 3 |
| Phase 1 | 152 | 114 | 5 | 28 |
| Phase 2 | 422 | 269 | 14 | 90 |
| Phase 3 | 68 | 40 | 2 | 12 |
| Phase 4 | 14 | 9 | 0 | 2 |
| All trials | 684 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Roche | Applicant and Lead sponsor of trials | 2001 to now |
| Astellas | Applicant and Lead sponsor of trials | 2001 to now |
| Cheplapharm | Applicant | 2005 to now |