Dupilumab
As of the edition of 20 October 2026, Dupilumab is an antibody: marketed, first approved in 2017 (US); acts on IL4R; US protection ends in 2031.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2019
- Kind
- Antibody
- Brand name
- Dupixent
- First approved
- 28 March 2017 (US)
- Approvals on record
- 22 in 5 regions
- Holder of the most recent approval
- Sanofi; 3 holders in all
- Registered trials
- 216, 14 stopped early
- Disease areas
- Immune system; Skin and connective tissue; Inherited and neonatal; Lungs and airways; Blood and lymph; Ear, nose and throat
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 Regeneron.
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.
See the exact date and the 2 listings behind itRequest access. Nothing is shown until you do.
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 Dupilumab.
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 |
|---|---|---|
| IL4R | Interleukin-4 receptor subunit alpha | P24394 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 50 | 10 | 29 | 3 |
| Phase 1 | 19 | 13 | 4 | 2 |
| Phase 2 | 47 | 28 | 14 | 3 |
| Phase 3 | 49 | 37 | 9 | 3 |
| Phase 4 | 51 | 23 | 19 | 3 |
| All trials | 216 |