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 23h ago · AI intelligence enriched 2d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
SEMPREX-D is a fixed-dose oral combination of acrivastine (H1-antihistamine) and pseudoephedrine (sympathomimetic decongestant) approved in 1994 for allergic rhinitis and related allergic conditions. Acrivastine rapidly blocks histamine receptors while pseudoephedrine relieves nasal congestion via norepinephrine release. The two agents have no pharmacologic interaction and exhibit complementary mechanisms for symptom relief.
LOE Approaching
Product is approaching end-of-life with moderate competitive pressure; commercial teams are likely in defense or transition mode with limited growth opportunities.
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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