NDATOPICALCREAM
Approved
Dec 2003
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
1
Data completeness
6/8 — Strong
ERTACZO (sertaconazole nitrate) by Lacer is 12. Approved for tinea pedis, vulvovaginal candidiasis. First approved in 2003.
Drug data last refreshed Yesterday · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ERTACZO (sertaconazole nitrate) is a topical azole antifungal cream approved for tinea pedis and vulvovaginal candidiasis. It works by inhibiting fungal cytochrome P450-mediated 14α-lanosterol demethylase, disrupting ergosterol synthesis and causing fungal cell membrane damage. The drug demonstrates minimal systemic absorption with plasma concentrations below quantifiable levels even after multiple topical doses.
$0.9MPart D
LOE ApproachingProduct is approaching end of life with modest Medicare spending ($942K in 2023), indicating small brand team and declining commercial opportunity.
Mechanism of Action
12.1 Mechanism of Action Sertaconazole nitrate is an azole antifungal [see ] . 12.2 Pharmacokinetics In a multiple-dose pharmacokinetic trial that included 5 male subjects with interdigital tinea pedis (range of diseased area, 42 - 140 cm ; mean, 93 cm ), ERTACZO cream, 2%, was topically applied…
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.