TheraRadar
Data updated: Mar 29, 2026

ONSOLIS

FENTANYL CITRATE
Approved 2009-07-16
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
16
Years on Market

Details

Status
Discontinued
First Approved
2009-07-16
Routes
BUCCAL
Dosage Forms
FILM

Companies

ADALVO
Active Ingredient: FENTANYL CITRATE

ONSOLIS Approval History

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What ONSOLIS Treats

1 FDA approvals

Originally approved for its first indication in 2009 .

  • 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

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.

ONSOLIS FDA Label Details

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ONSOLIS Patents & Exclusivity

Latest Patent: Jul 2027

Patents (25 active)

US9597288 Expires Jul 23, 2027
+ 15 more patents
Source: FDA Orange Book

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Data Sources

FDA Approval: NDA022266 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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