TheraRadar

Pharma Intelligence, Simplified

Data updated: Mar 10, 2026

SOLODYN

MINOCYCLINE HYDROCHLORIDE
Approved 2006-05-08
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
19
Years on Market

Details

Status
Discontinued
First Approved
2006-05-08
Routes
ORAL
Dosage Forms
TABLET, EXTENDED RELEASE

Companies

BAUSCH
Active Ingredient: MINOCYCLINE HYDROCHLORIDE

SOLODYN Approval History

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What SOLODYN Treats

1 FDA approvals

Originally approved for its first indication in 2006 .

  • 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.

SOLODYN FDA Label Details

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SOLODYN Patents & Exclusivity

Latest Patent: Nov 2031

Patents (96 active)

US9192615 Expires Nov 17, 2031
US7541347 Expires Apr 2, 2027
US7544373 Expires Apr 2, 2027
US7919483 Expires Mar 7, 2027
+ 86 more patents
Source: FDA Orange Book

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Data Sources

FDA Approval: NDA050808 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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