UCERIS (nda203634)- (9MG)

Generic Name	BUDESONIDE	Innovator	SALIX
Dosage	9MG
ParaIV Filing	Yes	505(b)2 Filing	Yes
Last Patent Expiry	2031-Sep-07	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	UCERIS (budesonide) is a glucocorticosteroid indicated for the induction of remission in patients with active, mild to moderate ulcerative colitis.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
2	0	2

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
9MG	**	**	-	-	2

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	2

Manufacturing Details of UCERIS