NDAORALCAPSULE
Approved
Jul 1996
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
13
Data completeness
2/8 — Basic
Drug data last refreshed 19h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ALLEGRA (fexofenadine hydrochloride) is a second-generation selective H1-receptor antagonist indicated for allergic rhinitis and chronic urticaria. It is a small-molecule oral antihistamine that works by blocking histamine receptors to reduce allergic symptoms without significant central nervous system penetration.
LOE Approaching
Product approaching loss of exclusivity with moderate competitive pressure (30/100), indicating declining team investment and potential reallocation of commercial resources.
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 (13)
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
All Women Comparing Self-expanding ALLEGRA Valve to Any Other Balloon-expandable Valve
Started Feb 2024
130 enrolled
Aortic Stenosis, Severe
Bioequivalence Study of Fexofenadine Hydrochloride Orally Disintegrated Tablets 30 mg Under Fasting Condition
Started Feb 2011
80 enrolled
Healthy
Fexofenadine HCL - Pseudoephedrine HCL Combination Versus Allegra in Patients With Seasonal Allergic Rhinitis
Started Feb 2011
520 enrolled
Rhinitis Seasonal
Safety, Efficacy and Pharmacokinetic Study of Allegra in Pediatric Patients With Atopic Dermatitis (AD)
Started Nov 2010
100 enrolled
Atopic Dermatitis
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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.