TheraRadar
Data updated: May 26, 2026

OPANA ER (oxymorphone hydrochloride)

Pain Approved 2006-06-22
Jump to: Indications Approvals Trials Competitors Safety Patents
2
Indications
--
Phase 3 Trials
1
Priority Reviews
19
Years on Market

Details

Status
Discontinued
First Approved
2006-06-22
Patent Cliff
2029

Pro Metrics

Patent cliff and revenue data

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Routes
ORAL
Dosage Forms
TABLET, EXTENDED RELEASE

Companies

ENDO PHARMS ENDO OPERATIONS
Active Ingredient: OXYMORPHONE HYDROCHLORIDE

OPANA ER Approval History

2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
322 FDA actions from 2006 to 2024
Oct 2024 SUPPL
Update · REMS
FDA Letter
Dec 2023 SUPPL
Label · Labeling
FDA Letter Label
Apr 2022 SUPPL
Label · Labeling
FDA Letter Label

What OPANA ER 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.

OPANA ER FDA Label Details

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3 OB patents · 3 families · 53 international docs across 15 countries

OPANA ER Patents & Exclusivity

Latest Patent: Nov 2029

Patents (3 active)

US8871779 Expires Nov 22, 2029
US7851482 Expires Jul 10, 2029
US8808737 Expires Jun 21, 2027
Source: FDA Orange Book

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Deep insights for OPANA ER

Revenue Insights

  • • Quarterly revenue tracking
  • • Historical trend analysis

Patent Timeline

  • • Cliff: 2029
  • • 245 active patents

Trial Analysis

  • • Clinical trial tracking
  • • Development stage analysis

Competitive Landscape

  • • Competitor tracking
  • • Same target/indication analysis
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Data Sources

FDA Approval: NDA201655 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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