Data updated: Mar 10, 2026
NALOXONE HYDROCHLORIDE (AUTOINJECTOR)
NALOXONE HYDROCHLORIDE
Approved 2022-02-28
1
Indication
--
Phase 3 Trials
1
Priority Reviews
4
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2022-02-28
- Routes
- INTRAMUSCULAR, SUBCUTANEOUS
- Dosage Forms
- SOLUTION
NALOXONE HYDROCHLORIDE (AUTOINJECTOR) Approval History
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What NALOXONE HYDROCHLORIDE (AUTOINJECTOR) Treats
1 FDA approvalsOriginally approved for its first indication in 2022 .
- Other (1)
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
NALOXONE HYDROCHLORIDE (AUTOINJECTOR) FDA Label Details
ProNALOXONE HYDROCHLORIDE (AUTOINJECTOR) Patents & Exclusivity
Latest Patent: May 2031
Patents (6 active)
US10143792
Expires May 24, 2031
US10322239
Expires Feb 28, 2031
US9474869
Expires Feb 28, 2031
US8939943
Expires Feb 28, 2031
US9022022
Expires Feb 28, 2031
US9814838
Expires Feb 28, 2031
Source: FDA Orange Book
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.