ZORVOLEX (nda204592)- (18MG,35MG)

Generic Name	DICLOFENAC	Innovator	ZYLA
Dosage	18MG,35MG
ParaIV Filing	Yes	505(b)2 Filing	Yes
Last Patent Expiry	2030-Apr-23	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	2016-Oct-18
GAIN Expiry	None	Drug Complexity	No
Indication	ZORVOLEX is a nonsteroidal anti-inflammatory drug indicated for • management of mild to moderate acute pain • management of osteoarthritis pain.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
0	1	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
18MG	**	**	-	-	-
35MG	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	0

Manufacturing Details of ZORVOLEX