ORENITRAM (nda203496)- (EQ 0.125MG BASE,EQ 0.25MG BASE,EQ 1MG BASE,EQ 2.5MG BASE,EQ 5MG BASE)

Generic Name	TREPROSTINIL DIOLAMINE	Innovator	UNITED THERAP
Dosage	EQ 0.125MG BASE,EQ 0.25MG BASE,EQ 1MG BASE,EQ 2.5MG BASE,EQ 5MG BASE
ParaIV Filing	Yes	505(b)2 Filing	No
Last Patent Expiry	2031-Aug-11	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	Orenitram is a prostacyclin mimetic indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1).

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
0	1	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 0.125MG BASE	**	**	-	-	-
EQ 0.25MG BASE	**	**	-	-	-
EQ 1MG BASE	**	**	-	-	-
EQ 2.5MG BASE	**	**	-	-	-
EQ 5MG BASE	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	0

Manufacturing Details of ORENITRAM