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 8h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Butoconazole nitrate is a vaginal antifungal cream approved in 1997 for treating vulvovaginal candidiasis caused primarily by Candida albicans. It works as an imidazole derivative that inhibits fungal steroid synthesis, disrupting cell membrane integrity and ultimately causing osmotic disruption or growth inhibition of fungal cells. Administered vaginally with peak plasma levels achieved within 12-24 hours and minimal systemic absorption (1.7% average).
LOE Approaching
Product is approaching loss of exclusivity with moderate competitive pressure (30%), suggesting consolidation of brand support and transition planning ahead for internal teams.
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
Working on butoconazole nitrate offers limited career growth potential given the product's mature lifecycle stage and approaching loss of exclusivity. Roles are concentrated in commercial and medical affairs functions managing a stable but declining franchise.
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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.