KOVANAZE (oxymetazoline hydrochloride)
KOVANAZE is indicated for the treatment of Nasal Congestion; Common Cold; Hay Fever; Upper Respiratory Allergy; Sinus Congestion.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2016-06-29
- Patent Cliff
- 2030
- Routes
- NASAL
- Dosage Forms
- SPRAY, METERED
Companies
KOVANAZE Approval History
What KOVANAZE Treats
5 indicationsKOVANAZE is approved for 5 conditions since its original approval in 2016. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Nasal Congestion
- Common Cold
- Hay Fever
- Upper Respiratory Allergy
- Sinus Congestion
KOVANAZE 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 KOVANAZE
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
2 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT02630121 | PRO00001844 | Ph 4 | recruiting | Effect of Oxymetazoline Hydrochloride in Combination With Fluticasone Propionate on the Apnea Hypopnea Index (AHI) in Subject With Persistent Nasal Congestion and Mild Obstructive Sleep Apnea |
| NCT03954444 results posted | OXY2018-01 | Ph 3 | completed | A Clinical Endpoint Bioequivalence Study of "Oxymetazoline Hydrochloride Cream" |
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.
KOVANAZE FDA Label Details
Indications & Usage
FDA Label (PDF)KOVANAZE is indicated for the treatment of Nasal Congestion; Common Cold; Hay Fever; Upper Respiratory Allergy; Sinus Congestion.
Pro Intelligence Preview
Deep insights for KOVANAZE
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2030
- • 2 active patents
Trial Analysis
- • 8 total trials
- • Stage: Declining
Competitive Landscape
- • 20 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.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment