NDAOPHTHALMICSOLUTION/DROPS
Approved
Dec 1986
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
7
Data completeness
5/8 — Partial
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. First approved in 1986.
Drug data last refreshed 14h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
BETADINE (povidone-iodine 5%) is a broad-spectrum antiseptic solution administered as ophthalmic drops for preoperative skin preparation and infection prevention in eye surgery. It works by releasing iodine, which denatures bacterial proteins and rapidly reduces aerobic bacterial load by 3+ log10 units within 10 minutes. The product is indicated for ocular surface antisepsis in surgical settings.
$0.001BPart D
LOE ApproachingMinimal commercial spending and claim volume signal a mature, low-volume specialty product with limited growth potential for sales and marketing teams.
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
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (7)
SURGX Antimicrobial Gel Versus Povidone-iodine Skin Incision Prep in Total Shoulder Arthroplasty
Started Jun 2023
60 enrolled
SurgerySurgical Site InfectionCutibacterium Acnes+1 more
Treatment of Adenoviral Conjunctivitis With SHP640 Compared to Povidone-iodine (PVP-I) and Placebo
Started Mar 2017
219 enrolled
Adenoviral Conjunctivitis
Betadine Irrigation in Cesarean Section
Started Sep 2015
80 enrolled
Infection; Cesarean Section
Prevention of Surgical Site Infections: Effectiveness of Nasal Povidone-Iodine and Nasal Mupirocin
Started Mar 2011
1,874 enrolled
Surgical Site Infection
Povidone-iodine Antisepsis for Strabismus Surgery
Started Sep 2009
70 enrolled
StrabismusSurgeryEndophthalmitis
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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.