PSEUDOEPHEDRINE HYDROCHLORIDE AND CHLORPHENIRAMINE MALEATE
LOE Approachingchlorpheniramine maleate; pseudoephedrine hydrochloride
NDAORALCAPSULE, EXTENDED RELEASE
Approved
Mar 1985
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 1985.
Drug data last refreshed 2d ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
A combination oral decongestant and antihistamine indicated for relief of upper respiratory allergy symptoms including runny nose, itchy and watery eyes, sneezing, and throat itching due to hay fever and other allergies. Chlorpheniramine maleate blocks histamine receptors to reduce allergic response, while pseudoephedrine acts on α-sympathetic receptors to produce vasoconstriction and nasal decongestion. Delivered as an extended-release capsule for sustained symptom relief.
LOE Approaching
Product faces imminent loss of exclusivity with moderate competitive pressure (30/100), indicating cost-control and transition planning will dominate brand strategy.
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
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