TheraRadar
Data updated: May 26, 2026

RHOFADE (oxymetazoline hydrochloride)

Trial Activity: Declining
Dermatology Approved 2017-01-18

Rhofade (oxymetazoline hydrochloride) cream, 1% is indicated for the topical treatment of persistent facial erythema associated with rosacea in adults.

Source: FDA Label • MAYNE PHARMA

How RHOFADE Works

Oxymetazoline is an alpha-1A adrenoceptor agonist that acts as a vasoconstrictor to reduce the persistent facial redness associated with rosacea.

Development Insights

Padagis LLC conducting 1 trials (13%)
12 indications explored (Broad Platform)
allergic rhinitis (2 trials)
rosacea (1 trials)
erythema (1 trials)
1
Indication
--
Phase 3 Trials
9
Years on Market

Details

Status
Prescription
First Approved
2017-01-18
Patent Cliff
2035

Pro Metrics

Patent cliff and revenue data

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Routes
TOPICAL
Dosage Forms
CREAM

Companies

Active Ingredient: OXYMETAZOLINE HYDROCHLORIDE

RHOFADE Approval History

2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
1 FDA actions from 2017 to 2017 · 1 indication expansions
Jan 2017 ORIGINAL
New Indication · Type 10 - New Indication Submitted as Distinct NDA - Not Consolidated

What RHOFADE Treats

2 indications

RHOFADE is approved for 2 conditions since its original approval in 2017. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Rosacea
  • Facial Erythema
Source: FDA Label

RHOFADE Competitive Set

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Three rings of competition based on shared molecular targets and treated indications.

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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 RHOFADE

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JOURNEY
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BENZOYL PEROXIDE
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Shared indications:
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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"
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Active Pipeline

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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.

RHOFADE FDA Label Details

Indications & Usage

FDA Label (PDF)

RHOFADE is indicated for the treatment of Rosacea; Facial Erythema.

View full patent landscape →
7 OB patents · 3 families · 69 international docs across 14 countries

RHOFADE Patents & Exclusivity

Latest Patent: Jun 2035

Patents (7 active)

US9974773 Expires Jun 11, 2035
US10751325 Expires Jun 11, 2035
US12350255 Expires Jun 11, 2035
US10335391 Expires Jun 11, 2035
US11517560 Expires Jun 11, 2035
US8883838 Expires Dec 1, 2031
US7812049 Expires May 2, 2028
Source: FDA Orange Book

Pro Intelligence Preview

Deep insights for RHOFADE

Revenue Insights

  • Quarterly revenue tracking
  • Historical trend analysis

Patent Timeline

  • Cliff: 2035
  • 7 active patents

Trial Analysis

  • 8 total trials
  • Stage: Declining

Competitive Landscape

  • 12 similar drugs
  • Same target/indication analysis
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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