LAMISIL
LOE ApproachingNDAORALTABLET
Approved
May 1996
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
3
Data completeness
2/8 — Basic
Drug data last refreshed 4h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
LAMISIL (terbinafine) is an oral antifungal small molecule approved in 1996 for treatment of fungal infections, primarily onychomycosis (nail fungus) and dermatophyte infections. It works by inhibiting fungal squalene epoxidase, disrupting ergosterol synthesis and fungal cell membrane integrity. The drug is administered as an oral tablet, making it convenient for systemic fungal infection management.
LOE Approaching
Product is in late-stage lifecycle with approaching loss of exclusivity, signaling potential team consolidation and transition to generic defense strategies.
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.
Clinical Trials (3)
Fasting Study of Terbinafine Hydrochloride Tablets 250 mg and Lamisil® Tablets 250 mg
Started Feb 2004
36 enrolled
Healthy
Fed Study of Terbinafine Hydrochloride Tablets 250 mg and Lamisil® 250 mg
Started Feb 2004
36 enrolled
Healthy
Safety and Effectiveness of Giving Lamisil to HIV-Positive Subjects With Thrush Who Have Not Responded to Fluconazole Treatment
30 enrolled
Candidiasis, OralHIV Infections
Career Relevance
LAMISIL offers limited new career growth opportunities given its mature, LOE-approaching status and zero linked job openings. Roles available are typically defensive commercial positions focused on market share retention, generic transition, and managed care optimization rather than product launches or innovation.
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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.