Ofatumumab
As of the edition of 20 October 2026, Ofatumumab is an antibody: marketed, first approved in 2009 (US); acts on MS4A1; US protection ended in 2023.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2021
- Kind
- Antibody
- Brand name
- Arzerra
- First approved
- 26 October 2009 (US)
- Approvals on record
- 10 in 4 regions
- Holder of the most recent approval
- Novartis; 3 holders in all
- Withdrawn from market
- 28 February 2019 (in some regions)
- Registered trials
- 128, 28 stopped early
- Disease areas
- Immune system; Cancer; Blood and lymph; Nervous system; Skin and connective tissue; Infections
US protection
US protection ended in 2023.
The orphan exclusivity ended in 2023 (it covers one use only). The application that gives this date is held by Novartis.
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
2 companies on route B because of this drug.
Companies on route B for this drug
In the product2 companies are on route B because of Ofatumumab.
See the 2 companies on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| MS4A1 | B-lymphocyte antigen CD20 | P11836 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 12 | 6 | 5 | 0 |
| Phase 1 | 9 | 6 | 1 | 2 |
| Phase 2 | 78 | 58 | 4 | 16 |
| Phase 3 | 21 | 7 | 4 | 9 |
| Phase 4 | 8 | 5 | 2 | 1 |
| All trials | 128 |