RECARBRIO (nda212819)- (EQ 500MG BASE/VIAL;500MG/VIAL;250MG/VIAL)

Generic Name	CILASTATIN SODIUM; IMIPENEM; RELEBACTAM	Innovator	MSD MERCK CO
Dosage	EQ 500MG BASE/VIAL;500MG/VIAL;250MG/VIAL
ParaIV Filing	No	505(b)2 Filing	No
Last Patent Expiry	2033-Mar-21	NCE Excl Expiry	2024-Jul-16
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	RECARBRIO is a combination of imipenem, a penem antibacterial, cilastatin, a renal dehydropeptidase inhibitor, and relebactam, a betalactamase inhibitor, indicated in patients 18 years of age and older for the treatment of the following infections caused by susceptible gram-negative microorganisms:  Hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP)  Complicated urinary tract infections, including pyelonephritis (cUTI) in patients who have limited or no alternative treatment options.  Complicated intra-abdominal infections (cIAI) in patients who have limited or no alternative treatment options

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
0	0	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
EQ 500MG BASE/VIAL;500MG/VIAL;250MG/VIAL	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	0

Manufacturing Details of RECARBRIO