SEMPREX-D
LOE Approachingacrivastine; pseudoephedrine hydrochloride
NDAORALCAPSULE
Approved
Mar 1994
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
2/8 — Basic
SEMPREX-D (acrivastine; pseudoephedrine hydrochloride) is clinical pharmacology acrivastine, a structural analog of triprolidine hydrochloride, exhibits h 1 -antihistaminic activity in isolated tissues, animals, and humans, and has sedative effects in humans (see ). First approved in 1994.
Drug data last refreshed 20h ago · AI intelligence enriched 2mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
SEMPREX-D is an oral combination antihistamine and decongestant containing acrivastine (H1-receptor antagonist) and pseudoephedrine hydrochloride (sympathomimetic agent). It is indicated for relief of allergic rhinitis symptoms including sneezing, nasal congestion, and itchy/watery eyes. The two agents work synergistically without pharmacokinetic interaction to provide rapid symptom relief with minimal sedation.
LOE Approaching
Product approaching loss of exclusivity with moderate competitive pressure (30%); brand team likely focused on lifecycle extension and generic transition planning rather than growth initiatives.
Mechanism of Action
CLINICAL PHARMACOLOGY Acrivastine, a structural analog of triprolidine hydrochloride, exhibits H 1 -antihistaminic activity in isolated tissues, animals, and humans, and has sedative effects in humans (see ). The propionic acid derivative of acrivastine is a metabolite in several animal species (as…
Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
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