INVANZ (nda021337)- (EQ 1GM BASE/VIAL)

Generic Name	ERTAPENEM SODIUM	Innovator	MSD SUB MERCK
Dosage	EQ 1GM BASE/VIAL
ParaIV Filing	Yes	505(b)2 Filing	No
Last Patent Expiry	2017-Nov-15	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	INVANZ is a penem antibacterial indicated in adult patients and pediatric patients (3 months of age and older) for the treatment of the following moderate to severe infections caused by susceptible bacteria: • Complicated intra-abdominal infections. • Complicated skin and skin structure infections, including diabetic foot infections without osteomyelitis. • Community-acquired pneumonia. • Complicated urinary tract infections including pyelonephritis. • Acute pelvic infections including postpartum endomyometritis, septic abortion and post-surgical gynecologic infections. INVANZ is indicated in adults for the prophylaxis of surgical site infection following elective colorectal surgery.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
5	0	4

Other Developers

Total Other Developers	5

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
EQ 1GM BASE/VIAL	**	**	-	-	4

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	4

Manufacturing Details of INVANZ