Rituximab
As of the edition of 20 October 2026, Rituximab is an antibody: marketed, first approved in 1997 (US); acts on MS4A1; US protection ends in 2028.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2008
- Kind
- Antibody
- Brand name
- Rituxan
- First approved
- 26 November 1997 (US)
- Approvals on record
- 32 in 5 regions
- Holder of the most recent approval
- Pfizer; 8 holders in all
- Withdrawn from market
- 10 April 2019 (in some regions)
- Registered trials
- 1,910, 339 stopped early
- Disease areas
- Immune system; Blood and lymph; Cancer; Skin and connective tissue; Heart and blood vessels; Infections
US protection
US protection ends in 2028.
The orphan exclusivity ends in 2028 (it covers one use only). The application that gives this date is held by Roche.
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 product4 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
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 Rituximab.
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 |
|---|---|---|
| MS4A1 | B-lymphocyte antigen CD20 | P11836 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 117 | 65 | 19 | 11 |
| Phase 1 | 264 | 130 | 63 | 61 |
| Phase 2 | 1,123 | 540 | 256 | 208 |
| Phase 3 | 333 | 174 | 72 | 54 |
| Phase 4 | 73 | 38 | 14 | 5 |
| All trials | 1,910 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Biogen | Later holder and Lead sponsor of trials | 1995 to now |
| Roche | Applicant and Lead sponsor of trials | 1997 to now |
| Bayer | Applicant and Lead sponsor of trials | 2003 to now |
| Pfizer | Later holder and Lead sponsor of trials | 2006 to now |
| Zenyaku Kogyo | Later holder |