PRANDIN (nda020741)- (0.5MG,1MG,2MG)

Generic Name	REPAGLINIDE	Innovator	GEMINI LABS LLC
Dosage	0.5MG,1MG,2MG
ParaIV Filing	Yes	505(b)2 Filing	No
Last Patent Expiry	2018-Jun-12	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	PRANDIN is a glinide indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
6	1	4

Other Developers

Total Other Developers	2

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
0.5MG	**	**	-	-	1
1MG	**	**	-	-	2
2MG	**	**	-	-	2

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	3

Manufacturing Details of PRANDIN