TIVORBEX (nda204768)- (20MG,40MG)

Generic Name	INDOMETHACIN	Innovator	GENUS
Dosage	20MG,40MG
ParaIV Filing	No	505(b)2 Filing	Yes
Last Patent Expiry	2030-Apr-23	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	2017-Feb-24
GAIN Expiry	None	Drug Complexity	No
Indication	TIVORBEX is a nonsteroidal anti-inflammatory drug indicated for treatment of mild to moderate acute pain in adults.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
0	0	0

Other Developers

Total Other Developers	None

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
20MG	**	**	-	-	-
40MG	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	0

Manufacturing Details of TIVORBEX