LITFULO (NDA215830)- (EQ 50MG BASE)

Generic Name	RITLECITINIB TOSYLATE	Innovator	PFIZER
Dosage	EQ 50MG BASE
ParaIV Filing	No	505(b)2 Filing	No
Last Patent Expiry	2041-Oct-17	NCE Excl Expiry	2028-Jun-23
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	LITFULO is a kinase inhibitor indicated for the treatment of severe alopecia areata in adults and adolescents 12 years and older.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
0	0	0

Other Developers

Total Other Developers	1

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
EQ 50MG BASE	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	0

Manufacturing Details of LITFULO