INVOKAMET (nda204353)- (50MG;500MG,50MG;1GM,150MG;500MG,150MG;1GM)

Generic Name	CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE	Innovator	JANSSEN PHARMS
Dosage	50MG;500MG,50MG;1GM,150MG;500MG,150MG;1GM
ParaIV Filing	Yes	505(b)2 Filing	Yes
Last Patent Expiry	2030-Jul-06	NCE Excl Expiry	2018-Mar-29
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	INVOKAMET and INVOKAMET XR are a combination of canagliflozin, a sodium-glucose co-transporter 2 (SGLT2) inhibitor, and metformin hydrochloride (HCl), a biguanide, indicated:  as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus  Canagliflozin is indicated to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes mellitus and established cardiovascular disease  Canagliflozin is indicated to reduce the risk of end-stage kidney disease, doubling of serum creatinine, cardiovascular death, and hospitalization for heart failure in adults with type 2 diabetes mellitus and diabetic nephropathy with albuminuria.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
0	5	0

Other Developers

Total Other Developers	9

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
50MG;500MG	**	**	-	-	-
50MG;1GM	**	**	Up	-	-
150MG;500MG	**	**	Up	-	-
150MG;1GM	**	**	Up	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	0

Manufacturing Details of INVOKAMET