PIZENSY (nda211281)- (10GM)

Generic Name	LACTITOL	Innovator	BRAINTREE LABS
Dosage	10GM
ParaIV Filing	No	505(b)2 Filing	Yes
Last Patent Expiry	2037-May-12	NCE Excl Expiry	2025-Feb-12
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	PIZENSY is an osmotic laxative indicated for the treatment of chronic idiopathic constipation (CIC) in adults.

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
10GM	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	0

Manufacturing Details of PIZENSY