Data updated: May 26, 2026
XYZAL ALLERGY 24HR (levocetirizine dihydrochloride)
Respiratory
Approved 2017-01-31
1
Indication
--
Phase 3 Trials
9
Years on Market
Details
- Status
- Over-the-counter
- First Approved
- 2017-01-31
- Patent Cliff
- 2027
- Routes
- ORAL
- Dosage Forms
- TABLET, SOLUTION
XYZAL ALLERGY 24HR Approval History
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
8 FDA actions from 2017 to 2026
What XYZAL ALLERGY 24HR Treats
1 FDA approvalsOriginally approved for its first indication in 2017 .
- Other (1)
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Clinical Trial Registry
4 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04699604 HAS3 | STUDY00001262 5R01HD100545-05 | Ph 3 | recruiting | A Histamine Pharmacodynamic Biomarker to Guide Treatment in Pediatric Asthma (HAS3) |
| NCT00621959 results posted | A00430 | Ph 4 | completed | A Study Evaluating the Efficacy and Impact on Health-related Quality of Life of Levocetirizine in Adults With Seasonal Allergic Rhinitis |
| NCT01567501 | Ipca/ARL/059 | Ph 1 | completed | Bioequivalence Study of Levocetirizine Dihydrochloride Tablets 5 mg Under Fed Condition |
| NCT00653224 results posted | A00431 | Ph 4 | completed | A Study Evaluating the Efficacy and Impact on Health-related Quality of Life of Levocetirizine in Adults With Seasonal Allergic Rhinitis |
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Pro Active Pipeline
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Pro Key Completed Trials
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.
XYZAL ALLERGY 24HR FDA Label Details
View full patent landscape →
1 OB patents · 1 families ·
39 international docs across 26 countries
XYZAL ALLERGY 24HR Patents & Exclusivity
Latest Patent: Oct 2027
Patents (1 active)
US8633194
Expires Oct 16, 2027
Source: FDA Orange Book
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Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2027
- • 1 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
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.