NIASPAN (nda020381)- (1GM,375MG,500MG,750MG)

Generic Name	NIACIN	Innovator	ABBVIE
Dosage	1GM,375MG,500MG,750MG
ParaIV Filing	Yes	505(b)2 Filing	Yes
Last Patent Expiry	2022-Jun-18	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	NIASPAN contains extended-release niacin (nicotinic acid), and is indicated: • To reduce elevated TC, LDL-C, Apo B and TG, and to increase HDL-C in patients with primary hyperlipidemia and mixed dyslipidemia. • To reduce the risk of recurrent nonfatal myocardial infarction in patients with a history of myocardial infarction and hyperlipidemia. • In combination with a bile acid binding resin: ◦ Slows progression or promotes regression of atherosclerotic disease in patients with a history of coronary artery disease (CAD) and hyperlipidemia. ◦ As an adjunct to diet to reduce elevated TC and LDL-C in adult patients with primary hyperlipidemia. • To reduce TG in adult patients with severe hypertriglyceridemia.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
14	0	10

Other Developers

Total Other Developers	4

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
1GM	**	**	-	-	6
375MG	**	**	-	-	-
500MG	**	**	-	-	6
750MG	**	**	-	-	3

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	9

Manufacturing Details of NIASPAN