Abatacept
As of the edition of 20 October 2026, Abatacept is a protein: marketed, first approved in 2005 (US); acts on CD80 and CD86; US protection ends in 2028.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2010
- Kind
- Protein
- Brand name
- Orencia
- First approved
- 23 December 2005 (US)
- Approvals on record
- 16 in 5 regions
- Holder of the most recent approval
- Bristol Myers Squibb
- Registered trials
- 164, 17 stopped early
- Disease areas
- Immune system; Skin and connective tissue; Bones, joints and muscles; Blood and lymph; Nervous system; Heart and blood vessels
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 Bristol Myers Squibb.
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.
Targets
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 22 | 15 | 1 | 1 |
| Phase 1 | 28 | 18 | 2 | 4 |
| Phase 2 | 57 | 32 | 13 | 7 |
| Phase 3 | 36 | 24 | 5 | 4 |
| Phase 4 | 21 | 16 | 0 | 1 |
| All trials | 164 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Bristol Myers Squibb | Applicant and Lead sponsor of trials | 2005 to now |