TheraRadar
Data updated: Mar 29, 2026

OTIPRIO

CIPROFLOXACIN
Approved 2015-12-10
Jump to: Indications Approvals Trials Competitors Safety Patents
2
Indications
--
Phase 3 Trials
10
Years on Market

Details

Status
Discontinued
First Approved
2015-12-10
Routes
OTIC
Dosage Forms
INJECTABLE, SUSPENSION

Companies

ALK ABELLO
Active Ingredient: CIPROFLOXACIN

OTIPRIO Approval History

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What OTIPRIO Treats

2 FDA approvals

Originally approved for its first indication in 2015 . 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.

OTIPRIO FDA Label Details

Pro

OTIPRIO Patents & Exclusivity

Latest Patent: Nov 2038

Patents (8 active)

US11246863 Expires Nov 27, 2038
US11040004 Expires Nov 12, 2037
US9220796 Expires Jul 1, 2035
US8318817 Expires Apr 27, 2030
US9233068 Expires Dec 11, 2029
US9603796 Expires Apr 21, 2029
US9205048 Expires Apr 21, 2029
US11369566 Expires Apr 21, 2029
Source: FDA Orange Book

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Data Sources

FDA Approval: NDA207986 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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