NDAVAGINALCREAM
Approved
Feb 1997
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
2/8 — Basic
BUTOCONAZOLE NITRATE (butoconazole nitrate) by Design Pharmaceuticals is clinical pharmacology following vaginal administration of butoconazole nitrate vaginal cream, 2% to 3 women, 1. First approved in 1997.
Drug data last refreshed 20h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Butoconazole nitrate is a topical imidazole antifungal cream administered vaginally to treat vulvovaginal candidiasis caused by Candida albicans. It works by inhibiting fungal sterol synthesis, disrupting cell membrane integrity and preventing fungal growth. The drug achieves peak plasma concentrations 12–24 hours post-administration with minimal systemic absorption (1.7% of dose).
LOE Approaching
Product is approaching loss of exclusivity with moderate competitive pressure (30/100), signaling potential team consolidation and shift toward generic defense or brand lifecycle extension strategies.
Mechanism of Action
CLINICAL PHARMACOLOGY Following vaginal administration of butoconazole nitrate vaginal cream, 2% to 3 women, 1.7% (range 1.3-2.2%) of the dose was absorbed on average. Peak plasma levels (13.6-18.6 ng radioequivalents/mL of plasma) of the drug and its metabolites are attained between 12 and 24…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Career Relevance
Career opportunities on butoconazole nitrate are limited and defensive in nature, focused on protecting market share against generics and managing a mature, low-growth franchise. Professionals joining this product should expect roles in compliance, market access, and lifecycle management rather than launch excitement or clinical 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.