NDAOTICSOLUTION/DROPS
Approved
Apr 2016
Lifecycle
Peak
Competitive Pressure
8/100
Data completeness
3/8 — Basic
Drug data last refreshed 20h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
OTOVEL is a fixed-dose combination otic solution containing ciprofloxacin (a fluoroquinolone antibiotic) and fluocinolone acetonide (a corticosteroid) approved in 2016. It treats acute otitis externa and related ear infections by combining antimicrobial and anti-inflammatory mechanisms. The dual-agent formulation targets bacterial infection while reducing inflammation and associated pain.
$0.004BPart D
Peak3.9 years to LOEProduct is at peak commercial maturity with modest Part D penetration; brand team likely focused on maintaining market position and managing competitive erosion.
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
LOE in ~4 years — strategic planning for patent cliff underway
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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.