Infliximab
As of the edition of 20 October 2026, Infliximab is an antibody: marketed, first approved in 1998 (US); acts on TNF; US protection ended in 2018.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2002
- Kind
- Antibody
- Brand name
- Remicade
- First approved
- 24 August 1998 (US)
- Approvals on record
- 21 in 5 regions
- Holder of the most recent approval
- Celltrion; 11 holders in all
- Withdrawn from market
- 21 May 2026 (in some regions)
- Registered trials
- 324, 44 stopped early
- Disease areas
- Skin and connective tissue; Digestive system; Bones, joints and muscles; Immune system; Heart and blood vessels; Blood and lymph
US protection
US protection ended in 2018.
The orphan exclusivity ended in 2018 (it covers one use only). The application that gives this date is held by Johnson & Johnson.
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
3 companies on route B because of this drug.
Companies on route B for this drug
In the product3 companies are on route B because of Infliximab.
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Target
| Gene | Protein | UniProt |
|---|---|---|
| TNF | Tumor necrosis factor | P01375 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 103 | 60 | 15 | 10 |
| Phase 1 | 17 | 14 | 1 | 0 |
| Phase 2 | 56 | 23 | 13 | 15 |
| Phase 3 | 88 | 66 | 5 | 12 |
| Phase 4 | 60 | 32 | 12 | 7 |
| All trials | 324 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Johnson & Johnson | Applicant and Lead sponsor of trials | 1995 to now |
| Celltrion | Later holder and Lead sponsor of trials | 2012 to now |
| Pfizer | Later holder and Lead sponsor of trials | 2013 to now |
| Nippon Kayaku | Applicant | 2014 to now |
| Amgen | Later holder and Lead sponsor of trials | 2016 to now |
| Mitsubishi Tanabe Pharma | Later holder |