OTOVEL (ciprofloxacin hydrochloride)
OTOVEL is indicated for the treatment of Bacterial Conjunctivitis.
Details
- Status
- Prescription
- First Approved
- 2016-04-29
- Patent Cliff
- 2030
- Routes
- OTIC
- Dosage Forms
- SOLUTION/DROPS
Companies
OTOVEL Approval History
What OTOVEL Treats
1 indicationsOTOVEL is approved for 1 conditions since its original approval in 2016. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Bacterial Conjunctivitis
OTOVEL Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to OTOVEL
3 of 7FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
1 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT00596453 results posted | NA_00010549 | Ph 4 | terminated | Impact of Antibiotic Treatment on Prostate-Specific Antigen (PSA) Variability |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
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.
OTOVEL FDA Label Details
Indications & Usage
FDA Label (PDF)OTOVEL is indicated for the treatment of Bacterial Conjunctivitis.
OTOVEL Patents & Exclusivity
Patents (1 active)
Pro Intelligence Preview
Deep insights for OTOVEL
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2030
- • 1 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • 7 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.