NDAORALCAPSULE
Approved
Jul 2009
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
2
Data completeness
3/8 — Basic
Drug data last refreshed 8h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Cetirizine HCl is a second-generation H1-receptor antagonist antihistamine indicated for allergic rhinitis and urticaria. It is an oral capsule formulation that crosses the blood-brain barrier minimally, reducing sedation compared to first-generation antihistamines. This small molecule works by competitively blocking histamine at H1 receptors to reduce allergic symptoms.
LOE Approaching
LOE-stage product with moderate competitive pressure (30/100) suggests a defensive, cost-management focused commercial strategy with reduced team expansion.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (2)
Combination Study Of S-555739/Cetirizine HCl In Adult Patients With Seasonal Allergic Rhinitis
Started Jul 2012
779 enrolled
Seasonal Allergic Rhinitis
Randomized, Double Blind, Parallel Group, Placebo Controlled, Multi-Center Study of the Efficacy and Safety of Cetirizine HCl Syrup vs. Loratadine Syrup vs. Placebo in Treatment of Children With Seasonal Allergic Rhinitis (SAR)
Started Mar 2001
683 enrolled
Allergic RhinitisHay FeverSAR+1 more
Career Relevance
This LOE-stage product offers minimal career growth or upward mobility; it is a maintenance and defense role focused on protecting existing revenue against generic and OTC competition. Professionals joining this product should expect a 2-3 year career window focused on operational efficiency, cost reduction, and regulatory defense rather than innovation or market expansion.
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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.