NDAORALTABLET, ORALLY DISINTEGRATING
Approved
Jul 2007
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
6
Data completeness
3/8 — Basic
Drug data last refreshed 23h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Children's Allegra Hives is an oral, orally disintegrating tablet formulation of fexofenadine hydrochloride, a selective peripheral H1-receptor antagonist indicated for allergic conditions in pediatric populations. The drug works by blocking histamine receptors to reduce itching, hives, and other allergic symptoms without significant central nervous system penetration.
LOE Approaching
Product is approaching loss of exclusivity with moderate competitive pressure (30/100), indicating potential team consolidation and shift toward lifecycle extension or transition planning.
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 (6)
Study to Assess Safety and Efficacy of Fexofenadine Hydrochloride (HCL) + Pseudoephedrine HCL Fixed Dose Combination in Indian Male and Female Participants With Allergic Rhinitis (AR) Who Are 12 Years and Above
Started Jun 2025
203 enrolled
Rhinitis Allergic
Bioequivalence Study of Fexofenadine Hydrochloride Orally Disintegrated Tablets 30 mg Under Fasting Condition
Started Feb 2011
80 enrolled
Healthy
Bioequivalence Study of Dr.Reddy's Fexofenadine Hydrochloride 180 mg Tablets Under Fasting Conditions
Started Apr 2002
44 enrolled
Healthy
Bioequivalence Study of Dr. Reddy's Laboratories Limited Fexofenadine Hydrochloride 180 mg Tablets Under Fed Conditions
Started Apr 2002
30 enrolled
Healthy
Fexofenadine Hydrochloride 180 mg Tablets Under Fasting Conditions
Started Mar 2002
60 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.