NDAORALTABLET
Approved
Apr 1993
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
3/8 — Basic
Drug data last refreshed 18h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Claritin (loratadine) is a second-generation selective H1-receptor antagonist oral antihistamine approved in 1993 for allergic rhinitis and chronic urticaria. It provides non-sedating allergy relief by blocking histamine receptors without significant CNS penetration. The drug is now available in multiple formulations including tablets, liquids, and combination products.
LOE Approaching
As LOE approaches, the Claritin brand team is likely consolidating and focusing on generic competition management and niche formulation extensions rather than 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 (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 Manufacturing Transfer Study Comparing the Bioequivalence of a Single Oral Dose of Claritin-D 12-Hour Extended Release Tablet From 2 Different Manufactuers Under Fed Conditions in Healthy Adult Subjects
Started Apr 2018
29 enrolled
Clinical Pharmacology
A Manufacturing Transfer Study Comparing the Bioequivalence of a Single Oral Dose of Claritin-D 12-Hour Extended Release Tablet From 2 Different Manufacturers Under Fasted Conditions in Healthy Adult Subjects
Started Apr 2018
52 enrolled
Clinical Pharmacology
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
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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.