ELUCIREM (NDA216986)- (1.4553GM/3ML (485.1MG/ML),3.63825GM/7.5ML (485.1MG/ML),4.851GM/10ML (485.1MG/ML),7.2765GM/15ML (485.1MG/ML),14.553GM/30ML (485.1MG/ML),24.255GM/50ML (485.1MG/ML),48.51GM/100ML (485.1MG/ML))

Generic Name	GADOPICLENOL	Innovator	GUERBET
Dosage	1.4553GM/3ML (485.1MG/ML),3.63825GM/7.5ML (485.1MG/ML),4.851GM/10ML (485.1MG/ML),7.2765GM/15ML (485.1MG/ML),14.553GM/30ML (485.1MG/ML),24.255GM/50ML (485.1MG/ML),48.51GM/100ML (485.1MG/ML)
ParaIV Filing	No	505(b)2 Filing	No
Last Patent Expiry	2040-Jan-17	NCE Excl Expiry	2027-Sep-21
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	ELUCIREM is a gadolinium-based contrast agent indicated in adult and pediatric patients aged 2 years and older for use with magnetic resonance imaging (MRI) to detect and visualize lesions with abnormal vascularity in: • the central nervous system (brain, spine, and associated tissues), • the body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system).

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
1.4553GM/3ML (485.1MG/ML)	**	**	-	-	-
3.63825GM/7.5ML (485.1MG/ML)	**	**	-	-	-
4.851GM/10ML (485.1MG/ML)	**	**	-	-	-
7.2765GM/15ML (485.1MG/ML)	**	**	-	-	-
14.553GM/30ML (485.1MG/ML)	**	**	-	-	-
24.255GM/50ML (485.1MG/ML)	**	**	-	-	-
48.51GM/100ML (485.1MG/ML)	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	0

Manufacturing Details of ELUCIREM