NDAOPHTHALMICSOLUTION/DROPS
Approved
Dec 1986
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
7
Data completeness
6/8 — Strong
BETADINE (povidone-iodine) by Alcon is clinical pharmacology: a placebo-controlled study in 38 normal volunteers yielded data for 36 subjects who showed a mean log10 reduction of 3. Approved for surgical site infection, acute otitis externa. First approved in 1986.
Drug data last refreshed 20h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
BETADINE (povidone-iodine) is a broad-spectrum antiseptic solution administered topically to the eye for surgical site preparation and treatment of bacterial and fungal ocular infections. It works through a direct microbicidal mechanism, reducing aerobic bacterial counts by ~3 log10 units within 10 minutes of application. The drug is indicated for surgical site infection prevention, acute otitis externa, keratitis, corneal ulcers, and prosthetic joint infections.
$0.001BPart D
LOE ApproachingDeclining
As LOE approaches with minimal recent spending ($1K in 2023) and only 41 Part D claims, the brand team is likely in maintenance mode with limited growth investment and potential for staffing reductions.
Mechanism of Action
CLINICAL PHARMACOLOGY: A placebo-controlled study in 38 normal volunteers yielded data for 36 subjects who showed a mean log10 reduction of 3.05 log10 units in total aerobes at 10 minutes following prepping the skin with BETADINE* 5% Sterile Ophthalmic Prep Solution compared with reduction of 1.58…
Pharmacologic Class:
Antiseptic
Indications (2)
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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.