NDATOPICAL, VAGINALCREAM
Approved
Feb 2001
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
1
Data completeness
3/8 — Basic
MONISTAT 3 COMBINATION PACK (miconazole nitrate) by Design Pharmaceuticals is clinical pharmacology miconazole nitrate exhibits fungicidal activity in vitro against species of the genus candida. First approved in 2001.
Drug data last refreshed 7h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
MONISTAT 3 Combination Pack is a topical vaginal antifungal cream containing miconazole nitrate, a fungicidal agent effective against Candida species. It is indicated for the treatment of vulvovaginal candidiasis (yeast infection) and works by disrupting fungal cell membranes, though the precise mechanism remains incompletely characterized. The combination pack offers a convenient 3-day treatment regimen as an alternative to longer 7-day therapy.
LOE Approaching
Product is in late-stage maturity with approaching loss of exclusivity; commercial teams should anticipate headcount rationalization and focus shift toward generic defense or new formulation innovation.
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 3 COMBINATION PACK at Design Pharmaceuticals? 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.