VIMOVO (nda022511)- (EQ 20MG BASE;500MG,EQ 20MG BASE;375MG)

Generic Name	ESOMEPRAZOLE MAGNESIUM; NAPROXEN	Innovator	HORIZON
Dosage	EQ 20MG BASE;500MG,EQ 20MG BASE;375MG
ParaIV Filing	Yes	505(b)2 Filing	Yes
Last Patent Expiry	2031-Oct-17	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	VIMOVO is a combination of naproxen, a non-steroidal anti-inflammatory drug (NSAID), and esomeprazole magnesium, a proton pump inhibitor (PPI) indicated in adult and adolescent patients 12 years of age and older weighing at least 38 kg, requiring naproxen for symptomatic relief of arthritis and esomeprazole magnesium to decrease the risk of developing naproxenassociated gastric ulcers. The naproxen component of VIMOVO is indicated for relief of signs and symptoms of: • osteoarthritis, rheumatoid arthritis and ankylosing spondylitis in adults. • juvenile idiopathic arthritis (JIA) in adolescent patients. The esomeprazole magnesium component of VIMOVO is indicated to decrease the risk of developing naproxen-associated gastric ulcers.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
5	2	4

Other Developers

Total Other Developers	8

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
EQ 20MG BASE;500MG	**	**	-	-	3
EQ 20MG BASE;375MG	**	**	-	-	3

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	3

Manufacturing Details of VIMOVO