Ibuprofen
As of the edition of 20 October 2026, Ibuprofen is a small molecule: marketed, first approved in 1972 (CA); acts on PTGS1 and PTGS2; no US protection of its own is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2018
- Kind
- Small molecule
- Brand name
- Motrin
- First approved
- 31 December 1972 (CA)
- Approvals on record
- 77 in 8 regions
- Holder of the most recent approval
- Kenvue Brands; 27 holders in all
- Registered trials
- 435, 51 stopped early
- Disease areas
- Nervous system; Inherited and neonatal; Heart and blood vessels; Urinary and reproductive; Injuries; Lungs and airways
US protection
No US protection of its own is listed.
The FDA registers list no drug-substance patent or exclusivity of its own that counts for this drug.
Recordati Rare Diseases holds a later exclusivity on its own new formulation or combination product, ending 2032; it does not protect the original drug.
This is the US only.
Companies that need a new molecule because of this drug
11 company-target rows on route B because of this drug.
Companies on route B for this drug
In the product11 company-target rows are on route B because of Ibuprofen.
See the 11 company-target rows on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Targets
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 102 | 63 | 15 | 8 |
| Phase 1 | 70 | 58 | 3 | 4 |
| Phase 2 | 59 | 35 | 5 | 10 |
| Phase 3 | 87 | 60 | 4 | 13 |
| Phase 4 | 117 | 67 | 18 | 16 |
| All trials | 435 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Johnson & Johnson | Acquired holder, Later holder and Lead sponsor of trials | 1989 to now |
| Reckitt Benckiser | Applicant and Lead sponsor of trials | 1991 to now |
| Novartis | Later holder | 1995 to now |
| Cumberland Pharmaceuticals | Later holder and Lead sponsor of trials | 2002 to now |
| Pfizer | Later holder, Earlier holder and Lead sponsor of trials | 2002 to now |
| Abbott | Acquired holder | 2003 to now |
| Taro Pharmaceuticals | Later holder | 2004 to now |
| Recordati Rare Diseases | Applicant | 2004 to now |
| Bayer | Later holder and Lead sponsor of trials | 2011 to now |
| Moberg Pharma | Acquired holder | 2014 to now |
| Bionpharma | Acquired holder | 2016 to now |
| Senju Pharmaceutical | Applicant | 2018 to now |
| Haleon | Acquired holder and Lead sponsor of trials | 2023 to now |
| Kenvue Brands | Acquired holder | 2025 to now |
| Apotex | Acquired holder | 2026 to now |
| Basf | Later holder |