TheraRadar
Data updated: May 26, 2026

UPNEEQ (oxymetazoline hydrochloride)

Trial Activity: Declining
Ophthalmology Approved 2020-07-08

Upneeq is an ophthalmic medication used for adults who have acquired blepharoptosis, a condition characterized by drooping upper eyelids. It treats this issue by stimulating the specific muscles responsible for eyelid elevation. This medication helps patients with drooping lids achieve a more open and alert eye appearance.

Source: FDA Label • RVL PHARMS

How UPNEEQ Works

Upneeq works by acting as an alpha adrenoceptor agonist that targets a subset of receptors in the Mueller’s muscle of the eyelid. When the drug binds to these receptors, it causes the muscle to contract. This contraction results in the lifting of the eyelid.

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
5
Years on Market

Details

Status
Prescription
First Approved
2020-07-08
Patent Cliff
2039

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Patent cliff and revenue data

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Routes
OPHTHALMIC
Dosage Forms
SOLUTION/DROPS

Companies

Active Ingredient: OXYMETAZOLINE HYDROCHLORIDE

UPNEEQ Approval History

2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
3 FDA actions from 2020 to 2021
May 2021 SUPPL
Label · Labeling
Aug 2020 SUPPL
Label · Labeling
Jul 2020 ORIGINAL
Update

What UPNEEQ Treats

1 indications

UPNEEQ is approved for 1 conditions since its original approval in 2020. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Blepharoptosis
Source: FDA Label
📋

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

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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

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.

UPNEEQ FDA Label Details

Indications & Usage

FDA Label (PDF)

UPNEEQ is indicated for the treatment of Blepharoptosis.

View full patent landscape →
12 OB patents · 2 families · 95 international docs across 30 countries

UPNEEQ Patents & Exclusivity

Latest Patent: Dec 2039

Patents (12 active)

US11324722 Expires Dec 16, 2039
US10940138 Expires Dec 16, 2039
US10799481 Expires Dec 16, 2039
US11701343 Expires Dec 16, 2039
US10898573 Expires Dec 16, 2039
US10814001 Expires Dec 16, 2039
US11311515 Expires Dec 16, 2039
US11541036 Expires Dec 16, 2039
US11103482 Expires Dec 16, 2039
US8357714 Expires Aug 26, 2031
US9867808 Expires Aug 26, 2031
US10912765 Expires Aug 26, 2031
Source: FDA Orange Book

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Revenue Insights

  • Quarterly revenue tracking
  • Historical trend analysis

Patent Timeline

  • Cliff: 2039
  • 12 active patents

Trial Analysis

  • 8 total trials
  • Stage: Declining

Competitive Landscape

  • Competitor tracking
  • 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