Golimumab
As of the edition of 20 October 2026, Golimumab is an antibody: marketed, first approved in 2009 (CA); acts on TNF; US protection ends in 2032.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2017
- Kind
- Antibody
- Brand name
- Simponi
- First approved
- 7 April 2009 (CA)
- Approvals on record
- 19 in 5 regions
- Holder of the most recent approval
- Fuji Pharma Co., Ltd.; 6 holders in all
- Registered trials
- 94, 14 stopped early
- Disease areas
- Bones, joints and muscles; Skin and connective tissue; Immune system; Digestive system; Hormones; Nutrition and metabolism
US protection
US protection ends in 2032.
The orphan exclusivity ends in 2032 (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 product4 listings count towards this date. The exact date and each listing are in the product.
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Target
| Gene | Protein | UniProt |
|---|---|---|
| TNF | Tumor necrosis factor | P01375 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 22 | 11 | 2 | 4 |
| Phase 1 | 6 | 6 | 0 | 0 |
| Phase 2 | 18 | 9 | 5 | 4 |
| Phase 3 | 33 | 25 | 1 | 6 |
| Phase 4 | 15 | 10 | 0 | 0 |
| All trials | 94 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Johnson & Johnson | Applicant and Lead sponsor of trials | 2003 to now |