LAMISIL
LOE ApproachingNDAORALGRANULE
Approved
Sep 2007
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
3
Data completeness
2/8 — Basic
Drug data last refreshed 16h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
LAMISIL is an oral antifungal medication approved in 2007 as a small-molecule NDA by Novartis. While specific indications are not detailed in available data, oral LAMISIL is typically used to treat fungal infections such as onychomycosis (toenail fungus). The drug works through inhibition of fungal squalene epoxidase, disrupting ergosterol synthesis in fungal cell membranes.
LOE Approaching
Product approaching loss of exclusivity signals career focus shifting from growth maintenance to managed decline and transition planning within the brand team.
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)
Fed Study of Terbinafine Hydrochloride Tablets 250 mg and Lamisil® 250 mg
Started Feb 2004
36 enrolled
Healthy
Fasting Study of Terbinafine Hydrochloride Tablets 250 mg and Lamisil® Tablets 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
Working on LAMISIL in its LOE-approaching phase offers limited growth opportunity but valuable experience in mature-product management, generic competition strategy, and organizational transition planning. Career progression on this asset is best suited for professionals seeking to develop expertise in market defense, cost optimization, or portfolio rationalization.
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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.