TYVASO (nda022387)- (0.6MG/ML)

Generic Name	TREPROSTINIL	Innovator	UNITED THERAP
Dosage	0.6MG/ML
ParaIV Filing	Yes	505(b)2 Filing	No
Last Patent Expiry	2042-Feb-03	NCE Excl Expiry	Expired
ODE Expiry	2016-Jul-30	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	Tyvaso 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 (PH-ILD; 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	None

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
0.6MG/ML	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	0

Manufacturing Details of TYVASO