NDAORALSYRUP
Approved
Oct 1996
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
3/8 — Basic
Drug data last refreshed 23h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
CLARITIN HIVES RELIEF is an oral syrup formulation of loratadine, a second-generation histamine H1-receptor antagonist approved in 1996. It is indicated for the relief of hives and itching associated with urticaria and allergic conditions. Loratadine works by blocking histamine receptors, reducing the allergic response without significant sedation.
LOE Approaching
As a mature product approaching loss of exclusivity with moderate competitive pressure (30/100), commercial teams are likely focused on brand defense and cost management rather than growth initiatives.
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 (20)
Desloratadine,Phenylephrine Hcl,Ibuprofen Compared to Placebo in Treatment of Symptoms Associated With Common Cold/Flu
Started Dec 2020
150 enrolled
Cold
A Study to Learn What Participants Think of Treatment With Betamethasone Plus Loratadine to Treat Their Acute Allergic Rhinitis, Also Known as Hay Fever in Mexico
Started Nov 2020
153 enrolled
Rhinitis, Allergic
A Study to Evaluate Changes in Nasal Airflow of Loratadine/Pseudoephedrine Tablet and Fluticasone Propionate Nasal Spray in Subjects Following Allergen Exposure
Started Feb 2018
82 enrolled
Rhinitis, Allergic
A Study to Assess the Bioequivalence of Xisimin (Loratadine) Tablets Under Fasting and Fed Conditions in Healthy Participants Compared With Clarityne Tablets
Started Nov 2017
108 enrolled
Healthy
A Study to Assess the Relative Bioavailability of Xisimin (Loratadine) Tablets Under Fasting and Fed Conditions in Healthy Participants Compared to Clarityne Tablets
Started Jun 2017
28 enrolled
Healthy
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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.