TheraRadar
Data updated: Nov 8, 2026

CYKLX (articaine hydrochloride) · THEA PHARMA

Other Approved 2025-08-15
This product's label text is not in FDA's label database (openFDA, DailyMed). FDA's label document for this approval (Drugs@FDA PDF) →
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
1
Years on Market

Details

Status
Discontinued
First Approved
2025-08-15
Patent Cliff
2039

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Patent cliff and revenue data

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Routes
OPHTHALMIC
Dosage Forms
SOLUTION/DROPS

Companies

THEA PHARMA
Active Ingredient: ARTICAINE HYDROCHLORIDE

CYKLX Approval History

2026
Original
New Indication
New Form
Label Update
1 FDA actions from 2025 to 2025
Aug 2025 ORIGINAL
Update · Type 3 - New Dosage Form and Type 4 - New Combination
FDA Letter Label

What CYKLX Treats

1 FDA approvals

Originally approved for its first indication in 2025 .

  • Other (1)
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Active Pipeline

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Key Completed Trials

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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.

CYKLX FDA Label Details

This product's label text is not in FDA's label database (openFDA, DailyMed). FDA's label document for this approval (Drugs@FDA PDF) →

CYKLX Patents & Exclusivity

Latest Patent: Mar 2039
Exclusivity: Aug 2028

Patents (3 active)

US12403126 Expires Mar 27, 2039
US11826347 Expires Mar 27, 2039
US11096922 Expires Mar 27, 2039

Exclusivity

NP Until Aug 2028
Source: FDA Orange Book

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Revenue Insights

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Patent Timeline

  • • Cliff: 2039
  • • 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: NDA218643 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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