NDAOTICSOLUTION/DROPS
Approved
Apr 2016
Lifecycle
Peak
Competitive Pressure
8/100
Data completeness
3/8 — Basic
Drug data last refreshed 5h ago · AI intelligence enriched 5d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
OTOVEL is a fixed-dose combination otic solution containing ciprofloxacin (antibiotic) and fluocinolone acetonide (corticosteroid) approved in 2016 for ear infections. It combines bactericidal activity against gram-negative and gram-positive pathogens with anti-inflammatory effects to reduce otitis symptoms. The product targets acute otitis externa and related otic conditions via topical delivery to the ear canal.
$0.004BPart D
Peak3.8 years to LOEThe product is at peak commercial maturity with modest Medicare utilization; brand teams should focus on defending market position against generic entry approaching in late 2030.
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
Worked on OTOVEL at Salvat? Share your interview experience or compensation data (+7 days Pro)
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.