ASTEPRO
LOE ApproachingNDANASALSPRAY, METERED
Approved
Oct 2008
Lifecycle
LOE Approaching
Competitive Pressure
15/100
Data completeness
2/8 — Basic
Drug data last refreshed 43m ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ASTEPRO is an azelastine hydrochloride nasal spray, a phthalazinone derivative and selective histamine H1-receptor antagonist approved for allergic rhinitis. It works by blocking histamine-mediated allergic responses in the nasal cavity, with the active metabolite desmethylazelastine contributing additional H1-antagonist activity. The racemic formulation is administered as a metered nasal spray for topical delivery.
LOE Approaching1.6 years to LOE
Product approaching loss of exclusivity (2028) with moderate competitive pressure; brand teams are likely focused on lifecycle extension and transition planning 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.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Why This Matters for Your Career
Patent cliff in ~2 years — expect lifecycle management and generic defense hiring
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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.