Omidubicel
As of the edition of 20 October 2026, Omidubicel is a cell: marketed, first approved in 2023 (US); US protection ends in 2035.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2023
- Kind
- Cell
- Brand name
- Omisirge
- First approved
- 17 April 2023 (US)
- Approvals on record
- 1 in 1 region
- Holder of the most recent approval
- Gamida Cell
- Registered trials
- 6, 0 stopped early
- Disease areas
- Blood and lymph; Cancer; Immune system; Inherited and neonatal
US protection
US protection ends in 2035.
US protection ends in 2035, 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 Gamida Cell. 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 2 | 4 | 3 | 1 | 0 |
| Phase 3 | 2 | 2 | 0 | 0 |
| All trials | 6 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Gamida Cell | Originator and Lead sponsor of trials | 2010 to now |