NDAORALTABLET, EXTENDED RELEASE
Approved
Nov 1999
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
1/8 — Limited
Drug data last refreshed 10h ago · AI intelligence enriched 5d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ALEVE-D SINUS & COLD is a fixed-dose combination OTC tablet containing naproxen sodium (an NSAID) and pseudoephedrine hydrochloride (a decongestant) in extended-release formulation. It treats symptoms of sinus congestion, pain, and fever associated with the common cold and sinus conditions. The product provides dual therapeutic action by reducing inflammation and pain while simultaneously relieving nasal congestion.
LOE Approaching
Product approaching loss of exclusivity with moderate competitive pressure (30/100), suggesting teams are transitioning from growth to defensive strategies and cost management.
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.
Career Relevance
Working on ALEVE-D SINUS & COLD in its LOE-approaching phase means engaging in defensive market strategy, generic transition planning, and cost optimization rather than growth initiatives. Career development here emphasizes commercial execution, competitive positioning, and portfolio management skills applicable across the OTC category.
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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.