Fentanyl
As of the edition of 20 October 2026, Fentanyl is a small molecule: marketed, first approved in 1965 (ES); acts on OPRM1.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2010
- Kind
- Small molecule
- Brand name
- Innovar
- First approved
- 1 November 1965 (ES)
- Approvals on record
- 69 in 5 regions
- Holder of the most recent approval
- Exela Pharma Sciences; 22 holders in all
- Withdrawn from market
- 27 September 2018 (in some regions)
- Registered trials
- 466, 59 stopped early
- Disease areas
- Nervous system; Cancer; Lungs and airways; Mental health; Heart and blood vessels; Urinary and reproductive
US protection
No US approval on record.
With no US approval on record there are no listed US patents or exclusivities.
This is the US only.
Companies that need a new molecule because of this drug
6 companies on route B and 1 company on route A because of this drug.
Companies on route B for this drug
In the product6 companies are on route B because of Fentanyl.
See the 6 companies on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Companies on route A for this drug
In the product1 company is on route A because of Fentanyl.
See the 1 company on route A for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| OPRM1 | Mu-type opioid receptor | P35372 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 172 | 109 | 14 | 16 |
| Phase 1 | 29 | 23 | 3 | 0 |
| Phase 2 | 40 | 27 | 2 | 7 |
| Phase 3 | 83 | 58 | 8 | 11 |
| Phase 4 | 142 | 74 | 14 | 25 |
| All trials | 466 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Abbott | Later holder | 1985 to now |
| Johnson & Johnson | Later holder, Earlier holder and Lead sponsor of trials | 1990 to now |
| Teva | Acquired holder and Lead sponsor of trials | 2004 to now |
| Pfizer | Acquired holder and Lead sponsor of trials | 2005 to now |
| Collegium Pharmaceutical | Later holder and Lead sponsor of trials | 2006 to now |
| Archimedes | Later holder and Lead sponsor of trials | 2006 to now |
| Phoenix | Applicant | 2008 to now |
| Istituto Gentili | Later holder | 2009 to now |
| Hisamitsu Pharmaceutical | Applicant | 2010 to now |
| Gruenenthal | Later holder | 2010 to now |
| Mitsubishi Tanabe Pharma | Later holder | 2010 to now |
| INSYS Therapeutics | Later holder and Lead sponsor of trials | 2012 to now |
| Teikoku Seiyaku | Later holder | 2013 to now |
| Novartis | Acquired holder and Lead sponsor of trials | 2015 to now |
| Sentynl Therapeutics | Acquired holder | 2016 to now |
| Btcp Pharma | Acquired holder | 2019 to now |
| Hikma Pharmaceuticals | Acquired holder | 2020 to now |
| Adalvo | Acquired holder | 2022 to now |
| Exela Pharma Sciences | Later holder | 2023 to now |
| Rising Pharma | Acquired holder | 2023 to now |