Drug

Butoconazole

As of the edition of 20 October 2026, Butoconazole is a small molecule: marketed, first approved in 1985 (US); no US protection is listed.

Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.

The drug

Status
Marketed; latest approval 1985
Kind
Small molecule
Brand name
Femstat
First approved
25 November 1985 (US)
Approvals on record
4 in 1 region
Holder of the most recent approval
Padagis; 3 holders in all
Registered trials
3, 0 stopped early
Disease areas
Pregnancy and women's health; Urinary and reproductive; Infections

US protection

No US protection is listed.

The FDA registers list no drug-substance patent or exclusivity that counts for this drug.

This is the US only.

Registered trials

PhaseTrialsCompletedActiveStopped early
Phase not stated1100
Phase 32200
All trials3

Who has held its approvals

CompanyRoleYears
RocheAcquired holder2003 to now
BayerAcquired holder2005 to now
PadagisAcquired holder and Lead sponsor of trials2008 to now