INCRUSE ELLIPTA (nda205382)- (EQ 0.0625MG BASE/INH)

Generic Name	UMECLIDINIUM BROMIDE	Innovator	GLAXO GRP ENGLAND
Dosage	EQ 0.0625MG BASE/INH
ParaIV Filing	No	505(b)2 Filing	No
Last Patent Expiry	2030-Oct-11	NCE Excl Expiry	2018-Dec-18
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	INCRUSE ELLIPTA is an anticholinergic indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
0	0	0

Other Developers

Total Other Developers	2

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
EQ 0.0625MG BASE/INH	**	**	Up	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	0

Manufacturing Details of INCRUSE ELLIPTA