CELEBREX (nda020998)- (50MG,100MG,200MG,400MG)

Generic Name	CELECOXIB	Innovator	UPJOHN
Dosage	50MG,100MG,200MG,400MG
ParaIV Filing	Yes	505(b)2 Filing	No
Last Patent Expiry	2018-Apr-14	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	CELEBREX is a nonsteroidal anti-inflammatory drug indicated for: • Osteoarthritis (OA) • Rheumatoid Arthritis (RA) • Juvenile Rheumatoid Arthritis (JRA) in patients 2 years and older • Ankylosing Spondylitis (AS) • Acute Pain (AP) • Primary Dysmenorrhea (PD)

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
21	0	21

Other Developers

Total Other Developers	14

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
50MG	**	**	-	-	13
100MG	**	**	-	-	15
200MG	**	**	Up	-	15
400MG	**	**	-	-	12

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	14

Manufacturing Details of CELEBREX