TheraRadar
Data updated: May 26, 2026

ACUVUE THERAVISION WITH KETOTIFEN (ketotifen fumarate)

Ophthalmology Approved 2022-02-25
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
4
Years on Market

Details

Status
Discontinued
First Approved
2022-02-25
Patent Cliff
2030

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Patent cliff and revenue data

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Routes
OPHTHALMIC
Dosage Forms
DRUG-ELUTING CONTACT LENS

Companies

Johnson & Johnson
Active Ingredient: KETOTIFEN FUMARATE

ACUVUE THERAVISION WITH KETOTIFEN Approval History

2023
2024
2025
2026
Original
New Indication
New Form
Label Update
2 FDA actions from 2022 to 2022
Feb 2022 ORIGINAL
Update · Type 3 - New Dosage Form and Type 4 - New Combination
FDA Letter Label

What ACUVUE THERAVISION WITH KETOTIFEN Treats

1 FDA approvals

Originally approved for its first indication in 2022 .

  • Other (1)
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Clinical Trial Registry

2 trials
Trial Sponsor ID Phase Status Title
NCT01840605 results posted TAU-284-19 Ph 3 completed A Confirmatory Study of TAU-284 in Pediatric Patients With Atopic Dermatitis
NCT02984397 15-207-MUHC Ph 3 completed Chronic Widespread Pain and White Blood Cell Activation
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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.

ACUVUE THERAVISION WITH KETOTIFEN FDA Label Details

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2 OB patents · 2 families · 69 international docs across 16 countries

ACUVUE THERAVISION WITH KETOTIFEN Patents & Exclusivity

Latest Patent: Jun 2030

Patents (2 active)

US9962376 Expires Jun 27, 2030
US9474746 Expires Mar 27, 2028
Source: FDA Orange Book

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Deep insights for ACUVUE THERAVISION WITH KETOTIFEN

Revenue Insights

  • • Quarterly revenue tracking
  • • Historical trend analysis

Patent Timeline

  • • Cliff: 2030
  • • 2 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: NDA022388 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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