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 17h ago · AI intelligence enriched 3w 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 nasal decongestant) for symptomatic relief of allergic rhinitis. It addresses both histamine-mediated itch and congestion through dual mechanisms in a single 12-hour dosing formulation.
$0.764MPart D
LOE ApproachingApproaching loss of exclusivity with declining Part D spending signals a mature product managed by a smaller, stabilized team focused on market defense and generic transition planning.
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 offers limited career growth opportunity due to its LOE-approaching status and declining commercial footprint. This product is best suited for professionals seeking stability in a defensive market position or those transitioning into generic strategy and lifecycle management expertise.
Brand Manager
Worked on CLARINEX-D 12 HOUR at Merck & Co.? Share your interview experience or compensation data (+7 days Pro)
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.