Gynazole-1 - (2% Cream; Vaginal)

Generic Name	Butoconazole Nitrate	Innovator	KV Pharma
Dosage	2% Cream; Vaginal	Branded US Sales	Less Than $1000 mn
Probable FTF	Less Than 5	Known Para IV Filers	Less Than 5
Other ANDA developers	None	Tentative Approvals	None
Final Approvals	Less Than 5	Generic Launches	Less Than 5
Indication	It is an antifungal medication used to treat vaginal candida (yeast) infections
Complexities	Yes

Executive Summary

Patent Status

Launch Timelines and Competition

Company	FTF Status / 180 days exclusivity	30-Months stay	Current Litigation Status	Current Approval Status	Likelihood of launch
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Chronology Of Events