REMODULIN (nda021272)- (0.1MG/ML,0.2MG/ML,0.4MG/ML,1MG/ML,2.5MG/ML,5MG/ML,10MG/ML,20MG/ML)

Generic Name	TREPROSTINIL	Innovator	UNITED THERAP
Dosage	0.1MG/ML,0.2MG/ML,0.4MG/ML,1MG/ML,2.5MG/ML,5MG/ML,10MG/ML,20MG/ML
ParaIV Filing	Yes	505(b)2 Filing	No
Last Patent Expiry	2029-Mar-29	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	Remodulin is a prostacyclin vasodilator indicated for: • Treatment of pulmonary arterial hypertension (PAH; WHO Group 1) to diminish symptoms associated with exercise. Studies establishing effectiveness included patients with NYHA Functional Class II-IV symptoms and etiologies of idiopathic or heritable PAH (58%), PAH associated with congenital systemic-to-pulmonary shunts (23%), or PAH associated with connective tissue diseases (19%). • Patients who require transition from epoprostenol, to reduce the rate of clinical deterioration. The risks and benefits of each drug should be carefully considered prior to transition.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
5	0	4

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
0.1MG/ML	**	**	-	-	-
0.2MG/ML	**	**	-	-	-
0.4MG/ML	**	**	-	-	-
1MG/ML	**	**	-	-	-
2.5MG/ML	**	**	-	-	-
5MG/ML	**	**	-	-	-
10MG/ML	**	**	-	-	-
20MG/ML	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	3

Manufacturing Details of REMODULIN