Xospata - (40 mg; Tablet)

Generic Name	Gilteritinib Fumarate	Innovator	Astellas
Dosage	40 mg; Tablet	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	Less Than 5
Final Approvals	None	Generic Launches	None
Indication	XOSPATA is a kinase inhibitor indicated for the treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation as detected by an FDA-approved test
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