Jakafi - (5, 10, 15, 20, and 25 mg ; Tablet)

Generic Name	Ruxolitinib Phosphate	Innovator	Incyte
Dosage	5, 10, 15, 20, and 25 mg ; Tablet	Branded US Sales	More Than $1000 mn
Probable FTF	Less Than 5	Known Para IV Filers	Less Than 5
Other ANDA developers	More Than 5	Tentative Approvals	None
Final Approvals	None	Generic Launches	None
Indication	Jakafi is a kinase inhibitor indicated for treatment of: • intermediate or high-risk myelofibrosis, including primary myelofibrosis, post-polycythemia vera myelofibrosis and post-essential thrombocythemia myelofibrosis in adults. • polycythemia vera in adults who have had an inadequate response to or are intolerant of hydroxyurea. • steroid-refractory acute graft-versus-host disease in adult and pediatric patients 12 years and older. • chronic graft-versus-host disease after failure of one or two lines of systemic therapy in adult and pediatric patients 12 years and older.
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