TheraRadar
Data updated: Mar 29, 2026

ZURAMPIC

LESINURAD
Approved 2015-12-22
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
10
Years on Market

Details

Status
Discontinued
First Approved
2015-12-22
Routes
ORAL
Dosage Forms
TABLET

Companies

IRONWOOD PHARMS INC
Active Ingredient: LESINURAD

ZURAMPIC Approval History

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What ZURAMPIC Treats

1 FDA approvals

Originally approved for its first indication in 2015 .

  • 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.

ZURAMPIC FDA Label Details

Pro

ZURAMPIC Patents & Exclusivity

Latest Patent: Feb 2032

Patents (11 active)

US8546436 Expires Feb 29, 2032
US9956205 Expires Dec 28, 2031
US9216179 Expires Aug 1, 2031
US8357713 Expires Dec 22, 2029
US8084483 Expires Aug 17, 2029
US8546437 Expires Apr 29, 2029
US8283369 Expires Nov 26, 2028
US10183012 Expires Nov 26, 2028
+ 1 more patents
Source: FDA Orange Book

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Data Sources

FDA Approval: NDA207988 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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