NDAOTICSOLUTION/DROPS
Approved
Apr 2016
Lifecycle
Peak
Competitive Pressure
8/100
Data completeness
3/8 — Basic
Drug data last refreshed 13h ago · AI intelligence enriched 4d 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 topical corticosteroid) approved in 2016 for ear infections. It treats acute otitis media with tympanostomy tubes and acute otitis externa by combining antimicrobial and anti-inflammatory activity directly in the ear canal. The synergistic mechanism addresses both infection and inflammation simultaneously in otic conditions.
$0.004BPart D
Peak3.5 years to LOEProduct is at peak lifecycle stage with modest Part D spending, suggesting a mature specialty market with stable but limited team expansion opportunities.
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.