XIGDUO XR (nda205649)- (2.5MG;1GM,5MG;500MG,5MG;1GM,10MG;500MG,10MG;1GM)

Generic Name	DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE	Innovator	ASTRAZENECA AB
Dosage	2.5MG;1GM,5MG;500MG,5MG;1GM,10MG;500MG,10MG;1GM
ParaIV Filing	Yes	505(b)2 Filing	No
Last Patent Expiry	2031-May-12	NCE Excl Expiry	2019-Jan-08
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	XIGDUO XR is a combination of dapagliflozin, a sodium-glucose cotransporter 2 (SGLT2) inhibitor, and metformin, a biguanide, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.Dapagliflozin is indicated to reduce: • The risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and established cardiovascular disease or multiple cardiovascular risk factors. • The risk of cardiovascular death and hospitalization for heart failure in adults with heart failure (NYHA class II-IV) with reduced ejection fraction. • The risk of sustained eGFR decline, end-stage kidney disease, cardiovascular death and hospitalization for heart failure in adults with chronic kidney disease at risk of progression.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
0	4	0

Other Developers

Total Other Developers	28

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
2.5MG;1GM	**	**	Up	-	-
5MG;500MG	**	**	Up	-	-
5MG;1GM	**	**	Up	-	-
10MG;500MG	**	**	Up	-	-
10MG;1GM	**	**	Up	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	0

Manufacturing Details of XIGDUO XR