PROCYSBI (nda203389)- (EQ 25MG BASE,EQ 75MG BASE)

Generic Name	CYSTEAMINE BITARTRATE	Innovator	HORIZON
Dosage	EQ 25MG BASE,EQ 75MG BASE
ParaIV Filing	Yes	505(b)2 Filing	Yes
Last Patent Expiry	2037-Feb-16	NCE Excl Expiry	Expired
ODE Expiry	2020-Apr-30	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	PROCYSBI is a cystine-depleting agent indicated for the treatment of nephropathic cystinosis in adults and pediatric patients 1 year of age and older.

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
EQ 25MG BASE	**	**	-	-	-
EQ 75MG BASE	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	0

Manufacturing Details of PROCYSBI