Osimertinib
As of the edition of 20 October 2026, Osimertinib is a small molecule: marketed, first approved in 2015 (US); acts on EGFR; US protection ends in 2032.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2016
- Kind
- Small molecule
- Brand name
- Tagrisso
- First approved
- 13 November 2015 (US)
- Approvals on record
- 11 in 5 regions
- Holder of the most recent approval
- AstraZeneca; 2 holders in all
- Registered trials
- 259, 16 stopped early
- Disease areas
- Cancer; Lungs and airways; Nervous system; Digestive system; Hormones; Skin and connective tissue
US protection
US protection ends in 2032.
The last listed US drug-substance patent ends in 2032. The application that gives this date is held by AstraZeneca.
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 product28 listings count towards this date. The exact date and each listing are in the product.
See the exact date and the 28 listings behind itRequest 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 | 7 | 9 | 0 |
| Phase 1 | 58 | 28 | 19 | 8 |
| Phase 2 | 136 | 32 | 74 | 6 |
| Phase 3 | 39 | 6 | 30 | 2 |
| Phase 4 | 3 | 1 | 1 | 0 |
| All trials | 259 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| AstraZeneca | Originator, Applicant and Lead sponsor of trials | 2015 to now |