NDAORALSOLUTION
Approved
Jan 2017
Lifecycle
LOE Approaching
Competitive Pressure
15/100
Clinical Trials
3
Data completeness
4/8 — Partial
XYZAL ALLERGY 24HR (levocetirizine dihydrochloride) by Sanofi is levocetirizine, the active enantiomer of cetirizine, is an antihistamine; its principal effects are mediated via selective inhibition of h 1 receptors. First approved in 2017.
Drug data last refreshed 6h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
XYZAL ALLERGY 24HR is an oral solution containing levocetirizine dihydrochloride, the active S-enantiomer of cetirizine, used to treat allergic rhinitis and urticaria symptoms. It works by selectively inhibiting H1 receptors, demonstrating 2-fold higher receptor affinity than racemic cetirizine. The 24-hour formulation provides extended symptomatic relief with once-daily dosing.
LOE Approaching1.3 years to LOE
Product faces near-term loss of exclusivity (October 2027) in a crowded OTC allergy market with 15 documented competitors, likely requiring defensive positioning and reduced team investments.
Mechanism of Action
Levocetirizine, the active enantiomer of cetirizine, is an antihistamine; its principal effects are mediated via selective inhibition of H 1 receptors. The antihistaminic activity of levocetirizine has been documented in a variety of animal and human models. In vitro binding studies revealed that…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (3)
Efficacy and Safety of Concomitant Montelukast Sodium and Levocetirizine Dihydrochloride in Perennial Allergic Rhinitis (PAR) Patients
Started Jun 2012
283 enrolled
Perennial Allergic Rhinitis
Safety Study of Levocetirizine Dihydrochloride Oral Liquid Formulation in Children Aged 6 Months to 11 Months
Started Mar 2008
69 enrolled
Allergic RhinitisChronic Urticaria
Safety Study of Levocetirizine Dihydrochloride Oral Liquid Formulation in Children Aged 1 to Less Than 6 Years Suffering From Allergic Rhinitis or Chronic Urticaria of Unknown Origin
Started Mar 2008
173 enrolled
Allergic RhinitisChronic Urticaria
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.