TheraRadar
Data updated: May 26, 2026

MYDCOMBI (phenylephrine hydrochloride)

Ophthalmology Approved 2023-05-05
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
3
Years on Market

Details

Status
Discontinued
First Approved
2023-05-05
Patent Cliff
2031

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Patent cliff and revenue data

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Routes
OPHTHALMIC
Dosage Forms
SPRAY, METERED

Companies

EYENOVIA
Active Ingredient: PHENYLEPHRINE HYDROCHLORIDE , TROPICAMIDE

MYDCOMBI Approval History

2024
2025
2026
Original
New Indication
New Form
Label Update
1 FDA actions from 2023 to 2023
May 2023 ORIGINAL
Update · Type 5 - New Formulation or New Manufacturer
FDA Letter Label

What MYDCOMBI Treats

1 FDA approvals

Originally approved for its first indication in 2023 .

  • Other (1)
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Clinical Trial Registry

2 trials
Trial Sponsor ID Phase Status Title
NCT05997732 STARS Pro00126600 Ph 4 recruiting Sympathetic Neurovascular Transduction: Role of Adrenergic Receptors and Sex Differences
NCT03098680 PRIME PRIME (A094136) Ph 1 terminated A Study of the Pharmacokinetic and Pharmacodynamic Responses in Healthy and Altered Human Cardiovascular Systems
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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.

MYDCOMBI FDA Label Details

View full patent landscape →
3 OB patents · 1 families · 17 international docs across 2 countries

MYDCOMBI Patents & Exclusivity

Latest Patent: Jul 2031
Exclusivity: May 2026

Patents (3 active)

US11398306 Expires Jul 15, 2031
US10839960 Expires Jul 15, 2031
US11839487 Expires Jul 15, 2031

Exclusivity

NP Until May 2026
Source: FDA Orange Book

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Revenue Insights

  • • Quarterly revenue tracking
  • • Historical trend analysis

Patent Timeline

  • • Cliff: 2031
  • • 3 active patents

Trial Analysis

  • • Clinical trial tracking
  • • Development stage analysis

Competitive Landscape

  • • Competitor tracking
  • • Same target/indication analysis
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Data Sources

FDA Approval: NDA215352 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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