PSEUDOEPHEDRINE HYDROCHLORIDE AND CHLORPHENIRAMINE MALEATE
LOE Approachingchlorpheniramine maleate; pseudoephedrine hydrochloride
NDAORALCAPSULE, EXTENDED RELEASE
Approved
Aug 1988
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
2/8 — Basic
PSEUDOEPHEDRINE HYDROCHLORIDE AND CHLORPHENIRAMINE MALEATE (chlorpheniramine maleate; pseudoephedrine hydrochloride) by Ascentage Pharma. Approved for these symptoms due to hay fever, other upper respiratory allergies: runny nose itchy, watery eyes sneezing itching of the nose and 1 more indications. First approved in 1988.
Drug data last refreshed 2d ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
This is an oral, extended-release combination decongestant and first-generation antihistamine used to treat upper respiratory allergy symptoms including nasal congestion, runny nose, sneezing, and itchy/watery eyes. Pseudoephedrine acts as a sympathomimetic nasal decongestant while chlorpheniramine provides antihistamine relief. The product has been on the market since 1988 and addresses seasonal and perennial allergies.
LOE Approaching
This product faces imminent loss of exclusivity with moderate competitive pressure (30/100), signaling a transitional team focused on generic transition management rather than growth initiatives.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
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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.