NDAOTICSUSPENSION/DROPS1 Generic Approved
Approved
Jul 2003
Lifecycle
LOE Approaching
Competitive Pressure
45/100
Clinical Trials
7
Data completeness
6/8 — Strong
CIPRODEX (ciprofloxacin and dexamethasone) by Novartis is corticosteroid hormone receptor agonists [moa]. Approved for corticosteroid [epc], infections caused by susceptible isolates of the designated microorganisms in the specific conditions listed below: • acute otitis media (aom) in pediatric patients (age 6 months, older) with tympanostomy tubes due to staphylococcus aureus and 4 more indications. First approved in 2003.
Drug data last refreshed 20h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
CIPRODEX is a fixed-dose combination of ciprofloxacin (fluoroquinolone antibiotic) and dexamethasone (corticosteroid) administered as otic drops. It treats acute otitis media in pediatric patients with tympanostomy tubes by combining bacterial killing with anti-inflammatory action. The formulation leverages ciprofloxacin's broad-spectrum activity against common otopathogens including Pseudomonas aeruginosa while dexamethasone reduces inflammation.
$0.006BPart D
LOE ApproachingProduct approaching loss of exclusivity with modest Part D utilization (22K claims) signals declining commercial opportunity and potential team consolidation.
Mechanism of Action
Corticosteroid Hormone Receptor Agonists
Pharmacologic Class:
Corticosteroid
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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.