VIBERZI (nda206940)- (75MG,100MG)

Generic Name	ELUXADOLINE	Innovator	ABBVIE
Dosage	75MG,100MG
ParaIV Filing	Yes	505(b)2 Filing	No
Last Patent Expiry	2033-Mar-14	NCE Excl Expiry	2020-May-27
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	VIBERZI is a mu-opioid receptor agonist, indicated in adults for the treatment of irritable bowel syndrome with diarrhea (IBS-D).

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
1	4	0

Other Developers

Total Other Developers	7

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
75MG	**	**	Up	-	-
100MG	**	**	Up	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	0

Manufacturing Details of VIBERZI