NDAOTICSUSPENSION/DROPS1 Generic Approved
Approved
Jul 2003
Lifecycle
LOE Approaching
Competitive Pressure
45/100
Data completeness
5/8 — Partial
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 2h ago · AI intelligence enriched 5d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
CIPRODEX is a fixed-dose combination otic suspension containing ciprofloxacin (fluoroquinolone antibiotic) and dexamethasone (corticosteroid) approved for acute otitis media in pediatric patients with tympanostomy tubes. It targets bacterial infections caused by susceptible pathogens including Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis, and Pseudomonas aeruginosa. The dual mechanism combines antimicrobial activity with anti-inflammatory action for localized middle ear treatment.
$6MPart D
LOE ApproachingProduct approaching loss of exclusivity with modest Part D spending of $6M and 22,355 claims in 2023; commercial teams should anticipate defensive positioning and generic transition planning.
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.