NDAINHALATIONAEROSOL, METERED
Approved
Jun 2010
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
1
Data completeness
4/8 — Partial
Drug data last refreshed 11h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
DULERA is a fixed-dose combination inhaler containing mometasone furoate (inhaled corticosteroid) and formoterol fumarate (long-acting beta-2 agonist) approved for maintenance treatment of asthma. It combines anti-inflammatory and bronchodilator mechanisms to reduce airway inflammation and improve airflow in asthma patients. The product represents a standard-of-care maintenance therapy for moderate-to-severe persistent asthma.
$0.117BPart D
LOE ApproachingProduct approaching loss of exclusivity with moderate Part D utilization (~252K claims in 2023); commercial teams should prepare defensive strategies and brand repositioning as generic pressure intensifies.
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.
Clinical Trials (1)
Improving Asthma Control in the Real World: A Systematic Approach to Improving Dulera Adherence
Started Mar 2014
50 enrolled
Asthma
Why This Matters for Your Career
$117M Medicare spend — this is a commercially significant brand
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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.