Ibritumomab tiuxetan
As of the edition of 20 October 2026, Ibritumomab tiuxetan is an antibody: marketed, first approved in 2002 (US); acts on MS4A1; US protection ended in 2014.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2002
- Kind
- Antibody
- Brand name
- Zevalin
- First approved
- 19 February 2002 (US)
- Approvals on record
- 1 in 1 region
- Holder of the most recent approval
- Acrotech Biopharma
- Withdrawn from market
- 4 January 2024 (in some regions)
- Registered trials
- 16, 4 stopped early
- Disease areas
- Blood and lymph; Cancer; Immune system; Infections; Heart and blood vessels
US protection
US protection ended in 2014.
US protection ended in 2014, 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 Acrotech Biopharma. 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.
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 Ibritumomab tiuxetan.
Target
| Gene | Protein | UniProt |
|---|---|---|
| MS4A1 | B-lymphocyte antigen CD20 | P11836 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 3 | 3 | 0 | 0 |
| Phase 1 | 1 | 1 | 0 | 0 |
| Phase 2 | 9 | 5 | 0 | 3 |
| Phase 3 | 3 | 2 | 0 | 1 |
| All trials | 16 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Zydus Worldwide DMCC | Earlier holder | 2002 to now |
| Acrotech Biopharma | Acquired holder | 2023 to now |