TheraRadar

Pharma Intelligence, Simplified

Data updated: Mar 10, 2026

IONSYS

FENTANYL HYDROCHLORIDE
Approved 2006-05-22
Jump to: Indications Approvals Trials Competitors Safety Patents
2
Indications
--
Phase 3 Trials
19
Years on Market

Details

Status
Discontinued
First Approved
2006-05-22
Routes
IONTOPHORESIS, TRANSDERMAL
Dosage Forms
SYSTEM

Companies

THE MEDICINES CO
Active Ingredient: FENTANYL HYDROCHLORIDE

IONSYS Approval History

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What IONSYS Treats

2 FDA approvals

Originally approved for its first indication in 2006 . Covers 2 distinct patient populations.

  • Other (2)
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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

ClinicalTrials.gov ↗ Pro

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.

IONSYS FDA Label Details

Pro

IONSYS Patents & Exclusivity

Latest Patent: Feb 2033

Patents (7 active)

US9095706 Expires Feb 3, 2033
US8428709 Expires Jun 11, 2032
US8428708 Expires May 21, 2032
US8781571 Expires Mar 31, 2032
US9731121 Expires Oct 17, 2031
US9364656 Expires Sep 30, 2031
US8301238 Expires Sep 30, 2031
Source: FDA Orange Book

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Data Sources

FDA Approval: NDA021338 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.