NDATOPICAL, VAGINALCREAM, SUPPOSITORY
Approved
Jun 1999
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
1
Data completeness
3/8 — Basic
MONISTAT DUAL- PAK (miconazole nitrate) by Personal Genomics is clinical pharmacology miconazole nitrate exhibits fungicidal activity in vitro against species of the genus candida. First approved in 1999.
Drug data last refreshed 41m ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
MONISTAT DUAL-PAK is a topical vaginal antifungal containing miconazole nitrate, a small-molecule imidazole that exhibits fungicidal activity against Candida species. It is used to treat vulvovaginal candidiasis (yeast infections) and is available in both suppository (200 mg for 3 days) and cream (2% for 7 days) formulations. The mechanism of action remains unknown, though miconazole demonstrates in vitro efficacy against Candida with minimal systemic absorption following vaginal administration.
LOE Approaching
Product lifecycle is approaching loss of exclusivity; team size and hiring are likely contracting as patent protection weakens and generic/OTC competition intensifies.
Mechanism of Action
CLINICAL PHARMACOLOGY Miconazole nitrate exhibits fungicidal activity in vitro against species of the genus Candida. The pharmacologic mode of action is unknown. Following intravaginal administration of miconazole nitrate, small amounts are absorbed. Administration of a single dose of miconazole…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (1)
Prospective Two-Year Study to Assess Miconazole Nitrate Resistance in Neonates and Infants
Started May 2007
200 enrolled
Diaper Rash
Worked on MONISTAT DUAL- PAK at Personal Genomics? Share your interview experience or compensation data (+7 days Pro)
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.