LONSURF (nda207981)- (EQ 6.14MG BASE;15MG,EQ 8.19MG BASE;20MG)

Generic Name	TIPIRACIL HYDROCHLORIDE; TRIFLURIDINE	Innovator	TAIHO ONCOLOGY
Dosage	EQ 6.14MG BASE;15MG,EQ 8.19MG BASE;20MG
ParaIV Filing	Yes	505(b)2 Filing	No
Last Patent Expiry	2037-Feb-03	NCE Excl Expiry	2020-Sep-22
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	LONSURF is a combination of trifluridine, a nucleoside metabolic inhibitor, and tipiracil, a thymidine phosphorylase inhibitor, indicated for the treatment of adult patients with: x metastatic colorectal cancer who have been previously treated with fluoropyrimidine-, oxaliplatin-and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type, an anti-EGFR therapy. x metastatic gastric or gastroesophageal junction adenocarcinoma previously treated with at least two prior lines of chemotherapy that included a fluoropyrimidine, a platinum, either a taxane or irinotecan, and if appropriate, HER2/neu-targeted therapy.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
1	1	0

Other Developers

Total Other Developers	3

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
EQ 6.14MG BASE;15MG	**	**	-	-	-
EQ 8.19MG BASE;20MG	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	0

Manufacturing Details of LONSURF