OMEPRAZOLE (nda022032)- (20MG)

Generic Name	OMEPRAZOLE	Innovator	DEXCEL PHARMA
Dosage	20MG
ParaIV Filing	Yes	505(b)2 Filing	Yes
Last Patent Expiry	2025-Aug-16	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	OMEPRAZOLE treats frequent heartburn (occurs 2 or more days a week).

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
3	0	2

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	**	**	Up	-	2

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	2

Manufacturing Details of OMEPRAZOLE