NDAORALTABLET, EXTENDED RELEASE
Approved
Feb 2006
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
1
Data completeness
6/8 — Strong
CLARINEX-D 12 HOUR (desloratadine and pseudoephedrine sulfate) by Merck & Co. is histamine h1 receptor antagonists [moa]. Approved for histamine-1 receptor antagonist [epc]. First approved in 2006.
Drug data last refreshed 20h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
CLARINEX-D 12 HOUR is an oral extended-release tablet combining desloratadine (a selective histamine H1 receptor antagonist) and pseudoephedrine sulfate (a decongestant) for symptomatic relief of allergic rhinitis. The desloratadine component blocks histamine-mediated allergic responses while pseudoephedrine reduces nasal congestion, providing dual-action allergy symptom relief. This combination targets patients seeking both antihistamine and decongestant benefits in a single 12-hour dosing regimen.
$0.764MPart D
LOE ApproachingDeclining
Product is approaching loss of exclusivity with minimal Part D penetration (1,260 annual claims), indicating a contracting market footprint that may reduce commercial team investment.
Mechanism of Action
Histamine H1 Receptor Antagonists
Pharmacologic Class:
Histamine-1 Receptor Antagonist
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (1)
Bioequivalence Study of Desloratadine and Pseudoephedrine Sulfate Extended-release Tablets Under Fasting Conditions
Started Apr 2006
34 enrolled
Healthy
Career Relevance
Working on CLARINEX-D 12 HOUR offers limited career expansion potential given the product's approaching loss of exclusivity and minimal linked job opportunities (0 positions). Professionals in this role focus on defending market share, managing the generic transition, and optimizing profitability rather than driving growth or innovation.
Brand Manager
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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.