YUTREPIA (NDA213005)- (EQ 0.0265MG BASE/INH)

Generic Name	TREPROSTINIL SODIUM	Innovator	LIQUIDIA TECH
Dosage	EQ 0.0265MG BASE/INH
ParaIV Filing	No	505(b)2 Filing	Yes
Last Patent Expiry	2037-May-05	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	2028-May-23
GAIN Expiry	None	Drug Complexity	No
Indication	YUTREPIA is a prostacyclin mimetic indicated for the treatment of: • Pulmonary arterial hypertension (PAH; WHO Group 1) to improve exercise ability. Studies establishing effectiveness predominately included patients with NYHA Functional Class III symptoms and etiologies of idiopathic or heritable PAH (56%) or PAH associated with connective tissue diseases (33%). • Pulmonary hypertension associated with interstitial lung disease (PHILD; WHO Group 3) to improve exercise ability. The study establishing effectiveness predominately included patients with etiologies of idiopathic interstitial pneumonia (IIP) (45%) inclusive of idiopathic pulmonary fibrosis (IPF), combined pulmonary fibrosis and emphysema (CPFE) (25%), and WHO Group 3 connective tissue disease (22%).

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
0	0	0

Other Developers

Total Other Developers	114

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
EQ 0.0265MG BASE/INH	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	0

Manufacturing Details of YUTREPIA