Data updated: Mar 10, 2026
EVZIO (AUTOINJECTOR)
NALOXONE HYDROCHLORIDE
Approved 2016-10-19
1
Indication
--
Phase 3 Trials
1
Priority Reviews
9
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2016-10-19
- Routes
- INTRAMUSCULAR, SUBCUTANEOUS
- Dosage Forms
- SOLUTION
EVZIO (AUTOINJECTOR) Approval History
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What EVZIO (AUTOINJECTOR) Treats
1 FDA approvalsOriginally approved for its first indication in 2016 .
- 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.
EVZIO (AUTOINJECTOR) FDA Label Details
ProEVZIO (AUTOINJECTOR) Patents & Exclusivity
Latest Patent: Mar 2035
Patents (21 active)
US10220158
Expires Mar 20, 2035
US9517307
Expires Jul 18, 2034
US8627816
Expires Feb 4, 2032
US10143792
Expires May 24, 2031
US9474869
Expires Feb 28, 2031
US10322239
Expires Feb 28, 2031
US8939943
Expires Feb 28, 2031
US9022022
Expires Feb 28, 2031
US8021344
Expires Nov 2, 2029
US8226610
Expires Apr 10, 2029
+ 11 more patents
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.