JELMYTO (nda211728)- (40MG/VIAL)

Generic Name	MITOMYCIN	Innovator	UROGEN PHARMA
Dosage	40MG/VIAL
ParaIV Filing	Yes	505(b)2 Filing	Yes
Last Patent Expiry	2031-Jan-20	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	2023-Apr-15
GAIN Expiry	None	Drug Complexity	No
Indication	JELMYTO is an alkylating drug indicated for the treatment of adult patients with low-grade Upper Tract Urothelial Cancer (LG-UTUC).

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
40MG/VIAL	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	0

Manufacturing Details of JELMYTO