TRACLEER (nda021290)- (62.5MG,125MG)

Generic Name	BOSENTAN	Innovator	ACTELION
Dosage	62.5MG,125MG
ParaIV Filing	No	505(b)2 Filing	No
Last Patent Expiry	2015-Nov-20	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	Tracleer is an endothelin receptor antagonist indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1): • in adults to improve exercise ability and to decrease clinical worsening. Studies establishing effectiveness included predominantly patients with WHO Functional Class II-IV symptoms and etiologies of idiopathic or heritable PAH (60%), PAH associated with connective tissue diseases (21%), and PAH associated with congenital heart disease with left-toright shunts (18%). • in pediatric patients aged 3 years and older with idiopathic or congenital PAH to improve pulmonary vascular resistance (PVR), which is expected to result in an improvement in exercise ability

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
6	0	6

Other Developers

Total Other Developers	3

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
62.5MG	**	**	-	-	-
125MG	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	5

Manufacturing Details of TRACLEER