TheraRadar

Pharma Intelligence, Simplified

Data updated: Mar 10, 2026

EVZIO

NALOXONE HYDROCHLORIDE
Approved 2014-04-03
1
Indication
--
Phase 3 Trials
1
Priority Reviews
11
Years on Market

Details

Status
Discontinued
First Approved
2014-04-03
Routes
INTRAMUSCULAR, SUBCUTANEOUS
Dosage Forms
SOLUTION

Companies

Active Ingredient: NALOXONE HYDROCHLORIDE

EVZIO Approval History

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What EVZIO Treats

1 FDA approvals

Originally approved for its first indication in 2014 .

  • Other (1)
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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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 FDA Label Details

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EVZIO Patents & Exclusivity

Latest Patent: Mar 2035

Patents (21 active)

US10220158 Expires Mar 20, 2035
US9517307 Expires Jul 18, 2034
US8627816 Expires Feb 4, 2032
US10143972 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.