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BUTOCONAZOLE NITRATE
Butoconazole nitrate is a marketed antifungal agent primarily indicated for vulvovaginal candidiasis. Its key strength lies in its established market presence, with a key composition patent expiring in 2028, providing a period of exclusivity. The primary risk is the potential increase in competition following the patent expiry in 2028.
At a glance
| Generic name | BUTOCONAZOLE NITRATE |
|---|---|
| Modality | Small molecule |
| Phase | FDA-approved |
| First approval | 1985 |
Approved indications
- Vulvovaginal candidiasis
Common side effects
- vulvar/vaginal burning, itching, soreness and swelling, pelvic or abdominal pain or cramping, or a combination of two or more of these symptoms
Key clinical trials
- A Randomized Study Evaluating the Therapeutic Equivalence of Two Butoconazole Nitrate Vaginal Cream, 2% Formulations (NA)
- Efficacy and Safety of Different Doses of Venus Association in Patients With Vulvovaginal Candidiasis. (PHASE2)
- Vaginal Infection Study 2 (PHASE3)
- Vaginal Infection Study (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- BUTOCONAZOLE NITRATE CI brief — competitive landscape report
- BUTOCONAZOLE NITRATE updates RSS · CI watch RSS