TheraRadar

Pharma Intelligence, Simplified

Data updated: Mar 10, 2026

DEXILANT SOLUTAB

DEXLANSOPRAZOLE
Approved 2016-01-26
2
Indications
--
Phase 3 Trials
10
Years on Market

Details

Status
Discontinued
First Approved
2016-01-26
Routes
ORAL
Dosage Forms
TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE

Companies

Active Ingredient: DEXLANSOPRAZOLE

DEXILANT SOLUTAB Approval History

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What DEXILANT SOLUTAB Treats

2 FDA approvals

Originally approved for its first indication in 2016 . 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

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.

DEXILANT SOLUTAB FDA Label Details

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DEXILANT SOLUTAB Patents & Exclusivity

Latest Patent: Mar 2029

Patents (7 active)

US9241910 Expires Mar 10, 2029
US8871273*PED Expires Jul 11, 2028
US8871273 Expires Jan 11, 2028
US8461187*PED Expires Jul 17, 2026
US9011926 Expires Feb 24, 2026
US9238029 Expires Jan 17, 2026
US8461187 Expires Jan 17, 2026
Source: FDA Orange Book

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Data Sources

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