XURIDEN (nda208169)- (2GM/PACKET)

Generic Name	URIDINE TRIACETATE	Innovator	BTG INTL
Dosage	2GM/PACKET
ParaIV Filing	No	505(b)2 Filing	Yes
Last Patent Expiry	2023-Jul-10	NCE Excl Expiry	2020-Sep-04
ODE Expiry	2022-Sep-04	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	XURIDEN is a pyrimidine analog for uridine replacement indicated in adult and pediatric patients for the treatment of hereditary orotic aciduria.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
0	0	0

Other Developers

Total Other Developers	None

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
2GM/PACKET	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	0

Manufacturing Details of XURIDEN