Durvalumab
As of the edition of 20 October 2026, Durvalumab is an antibody: marketed, first approved in 2017 (US); acts on CD274; US protection ends in 2031.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2018
- Kind
- Antibody
- Brand name
- Imfinzi
- First approved
- 1 May 2017 (US)
- Approvals on record
- 14 in 5 regions
- Holder of the most recent approval
- AstraZeneca
- Registered trials
- 744, 118 stopped early
- Disease areas
- Cancer; Lungs and airways; Digestive system; Urinary and reproductive; Pregnancy and women's health; Skin and connective tissue
US protection
US protection ends in 2031.
The orphan exclusivity ends in 2031 (it covers one use only). 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 product2 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 Durvalumab.
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 |
|---|---|---|
| CD274 | Programmed cell death 1 ligand 1 | Q9NZQ7 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 22 | 7 | 5 | 0 |
| Phase 1 | 144 | 58 | 46 | 35 |
| Phase 2 | 487 | 133 | 217 | 80 |
| Phase 3 | 86 | 21 | 62 | 3 |
| Phase 4 | 5 | 2 | 2 | 0 |
| All trials | 744 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| AstraZeneca | Applicant and Lead sponsor of trials | 2012 to now |