TheraRadar

Pharma Intelligence, Simplified

Data updated: Mar 10, 2026

ZORVOLEX

DICLOFENAC
Approved 2013-10-18
Jump to: Indications Approvals Trials Competitors Safety Patents
2
Indications
--
Phase 3 Trials
12
Years on Market

Details

Status
Discontinued
First Approved
2013-10-18
Routes
ORAL
Dosage Forms
CAPSULE

Companies

ZYLA
Active Ingredient: DICLOFENAC

ZORVOLEX Approval History

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What ZORVOLEX Treats

2 FDA approvals

Originally approved for its first indication in 2013 . 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

Pro

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.

ZORVOLEX FDA Label Details

Pro

ZORVOLEX Patents & Exclusivity

Latest Patent: Apr 2030

Patents (28 active)

US9186328 Expires Apr 23, 2030
US9180095 Expires Apr 23, 2030
US8999387 Expires Apr 23, 2030
US9180096 Expires Apr 23, 2030
US9017721 Expires Apr 23, 2030
US9173854 Expires Apr 23, 2030
US8679544 Expires Apr 23, 2030
+ 18 more patents
Source: FDA Orange Book

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Data Sources

FDA Approval: NDA204592 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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