BONIVA (nda021455)- (EQ 2.5MG BASE,EQ 150MG BASE)

Generic Name	IBANDRONATE SODIUM	Innovator	HOFFMANN LA ROCHE
Dosage	EQ 2.5MG BASE,EQ 150MG BASE
ParaIV Filing	Yes	505(b)2 Filing	No
Last Patent Expiry	2023-May-06	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	BONIVA is a bisphosphonate indicated for the treatment of osteoporosis in postmenopausal women.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
6	1	5

Other Developers

Total Other Developers	1

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
EQ 2.5MG BASE	**	**	-	-	-
EQ 150MG BASE	**	**	-	-	4

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	5

Manufacturing Details of BONIVA