TRELEGY ELLIPTA (nda209482)- (0.1MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH,0.2MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH)

Generic Name	FLUTICASONE FUROATE; UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE	Innovator	GLAXOSMITHKLINE
Dosage	0.1MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH,0.2MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH
ParaIV Filing	No	505(b)2 Filing	No
Last Patent Expiry	2031-Apr-11	NCE Excl Expiry	2018-Dec-18
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	TRELEGY ELLIPTA is a combination of fluticasone furoate, an inhaled corticosteroid (ICS); umeclidinium, an anticholinergic; and vilanterol, a long-acting beta2-adrenergic agonist (LABA), indicated for: • the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). • the maintenance treatment of asthma in patients aged 18 years and older.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
0	0	0

Other Developers

Total Other Developers	7

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
0.1MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH	**	**	Up	-	-
0.2MG/INH;EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH	**	**	Up	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	0

Manufacturing Details of TRELEGY ELLIPTA