Dinutuximab
As of the edition of 20 October 2026, Dinutuximab is an antibody: marketed, first approved in 2015 (US); US protection ends in 2027.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2021
- Kind
- Antibody
- Brand name
- Unituxin
- First approved
- 10 March 2015 (US)
- Approvals on record
- 4 in 3 regions
- Holder of the most recent approval
- OHARA PHARMACEUTICAL Co.,Ltd.; 3 holders in all
- Withdrawn from market
- 20 March 2017 (in some regions)
- Registered trials
- 29, 3 stopped early
- Disease areas
- Cancer; Lungs and airways; Nervous system
US protection
US protection ends in 2027.
US protection ends in 2027, computed as 12 years from the first US licence because FDA publishes no date for this product. The application that gives this date is held by United Therapeutics. The date is computed, not published.
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.
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 1 | 0 | 0 | 1 |
| Phase 1 | 6 | 2 | 3 | 1 |
| Phase 2 | 16 | 8 | 7 | 1 |
| Phase 3 | 6 | 3 | 2 | 0 |
| All trials | 29 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| United Therapeutics | Applicant and Lead sponsor of trials | 2012 to now |