Adalimumab
As of the edition of 20 October 2026, Adalimumab is an antibody: marketed, first approved in 2002 (US); acts on TNF; 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
- Humira
- First approved
- 31 December 2002 (US)
- Approvals on record
- 54 in 5 regions
- Holder of the most recent approval
- Amgen; 6 holders in all
- Withdrawn from market
- 18 December 2020 (in some regions)
- Registered trials
- 379, 30 stopped early
- Disease areas
- Skin and connective tissue; Bones, joints and muscles; Immune system; Digestive system; Eye; 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 AbbVie.
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
4 companies on route B and 1 company on route A because of this drug.
Companies on route B for this drug
In the product4 companies are on route B because of Adalimumab.
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Companies on route A for this drug
In the product1 company is on route A because of Adalimumab.
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Target
| Gene | Protein | UniProt |
|---|---|---|
| TNF | Tumor necrosis factor | P01375 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 77 | 48 | 9 | 4 |
| Phase 1 | 34 | 29 | 3 | 1 |
| Phase 2 | 56 | 27 | 14 | 12 |
| Phase 3 | 129 | 112 | 5 | 5 |
| Phase 4 | 83 | 42 | 15 | 8 |
| All trials | 379 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| AbbVie | Applicant and Lead sponsor of trials | 2000 to now |
| Pfizer | Later holder and Lead sponsor of trials | 2013 to now |
| Amgen | Applicant and Lead sponsor of trials | 2013 to now |
| Fujifilm Kyowa Kirin Biologics | Applicant and Lead sponsor of trials | 2014 to now |