Naloxone
As of the edition of 20 October 2026, Naloxone is a small molecule: marketed, first approved in 1977 (FR); acts on OPRD1, OPRK1 and OPRM1; 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 2007
- Kind
- Small molecule
- Brand name
- Narcan
- First approved
- 24 October 1977 (FR)
- Approvals on record
- 55 in 5 regions
- Holder of the most recent approval
- Hikma Pharmaceuticals; 19 holders in all
- Registered trials
- 192, 30 stopped early
- Disease areas
- Mental health; Chemically induced; Nervous system; Immune system; Cancer; Digestive system
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.
Scienture holds a later exclusivity on its own new formulation or combination product, ending 2027; it does not protect the original drug.
This is the US only.
Companies that need a new molecule because of this drug
10 company-target rows on route B because of this drug.
Companies on route B for this drug
In the product10 company-target rows are on route B because of Naloxone.
See the 10 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 | 38 | 24 | 2 | 6 |
| Phase 1 | 43 | 33 | 4 | 5 |
| Phase 2 | 41 | 30 | 1 | 7 |
| Phase 3 | 31 | 22 | 2 | 4 |
| Phase 4 | 39 | 23 | 6 | 8 |
| All trials | 192 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Indivior | Applicant and Lead sponsor of trials | 2006 to now |
| Purdue Pharma | Applicant and Lead sponsor of trials | 2009 to now |
| Kaleo | Later holder | 2014 to now |
| Adapt Pharma | Acquired holder | 2015 to now |
| Mundipharma | Later holder | 2017 to now |
| Accord Healthcare | Later holder | 2017 to now |
| Emergent Biosolutions | Acquired holder | 2021 to now |
| Hikma Pharmaceuticals | Later holder | 2021 to now |
| Baxter Healthcare | Later holder | 2021 to now |
| Adamis Pharmaceuticals | Later holder | 2021 to now |
| Amphastar Pharmaceuticals | Later holder | 2023 to now |
| Harm Reduction Therapeutics | Later holder | 2023 to now |
| Summit Therapeutics | Later holder | 2024 to now |
| Zmi Pharma | Acquired holder | 2024 to now |
| Scienture | Acquired holder | 2025 to now |