Acetaminophen
As of the edition of 20 October 2026, Acetaminophen is a small molecule: marketed, first approved in 1933 (ES); acts on FAAH, PTGS1 and PTGS2 and 1 more; 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 2011
- Kind
- Small molecule
- Brand name
- Tylenol
- First approved
- 1 August 1933 (ES)
- Approvals on record
- 81 in 7 regions
- Holder of the most recent approval
- Kenvue Brands; 42 holders in all
- Registered trials
- 825, 98 stopped early
- Disease areas
- Nervous system; Cancer; Immune system; Bones, joints and muscles; Infections; Heart and blood vessels
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.
Zevra Therapeutics holds a later exclusivity on its own new formulation or combination product, ending 2031; it does not protect the original drug.
This is the US only.
Companies that need a new molecule because of this drug
17 company-target rows on route B because of this drug.
Companies on route B for this drug
In the product17 company-target rows are on route B because of Acetaminophen.
See the 17 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 | 170 | 115 | 19 | 16 |
| Phase 1 | 121 | 89 | 13 | 12 |
| Phase 2 | 136 | 88 | 19 | 17 |
| Phase 3 | 146 | 95 | 18 | 17 |
| Phase 4 | 252 | 164 | 32 | 36 |
| All trials | 825 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Sanofi | Applicant and Lead sponsor of trials | 1982 to now |
| Bayer | Applicant and Lead sponsor of trials | 1987 to now |
| Johnson & Johnson | Applicant, Acquired holder, Later holder and Lead sponsor of trials | 1999 to now |
| Viatris | Later holder and Lead sponsor of trials | 2000 to now |
| Polymedica Industries | Acquired holder | 2003 to now |
| Baxter Healthcare | Later holder and Lead sponsor of trials | 2006 to now |
| Byk-Mallinckrodt CIL | Later holder and Lead sponsor of trials | 2006 to now |
| Reckitt Benckiser | Later holder and Lead sponsor of trials | 2009 to now |
| Terumo | Later holder | 2013 to now |
| Fresenius Kabi | Later holder | 2015 to now |
| Taro Pharmaceutical Industries | Acquired holder | 2018 to now |
| Cosette Pharmaceuticals | Acquired holder | 2020 to now |
| B. Braun Medical | Later holder | 2021 to now |
| Rising Pharma | Acquired holder | 2022 to now |
| Hikma Pharmaceuticals | Later holder | 2022 to now |
| Kenvue Brands | Acquired holder | 2025 to now |
| Alcon | Earlier holder | |
| Sanwa Kagaku Kenkyusho | Later holder | |
| Upsher-Smith | Later holder |