DOTAREM (nda204781)- (1.8845GM/5ML (376.9MG/ML),3.769GM/10ML (376.9MG/ML),5.6535GM/15ML (376.9MG/ML),7.538GM/20ML (376.9MG/ML),37.69GM/100ML (376.9MG/ML))

Generic Name	GADOTERATE MEGLUMINE	Innovator	GUERBET
Dosage	1.8845GM/5ML (376.9MG/ML),3.769GM/10ML (376.9MG/ML),5.6535GM/15ML (376.9MG/ML),7.538GM/20ML (376.9MG/ML),37.69GM/100ML (376.9MG/ML)
ParaIV Filing	No	505(b)2 Filing	No
Last Patent Expiry	Expired	NCE Excl Expiry	2018-Mar-20
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	DOTAREM is a gadolinium-based contrast agent indicated: for intravenous use with magnetic resonance imaging (MRI) in brain (intracranial), spine and associated tissues in adult and pediatric patients (including term neonates) to detect and visualize areas with disruption of the blood brain barrier (BBB) and/or abnormal vascularity.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
3	0	3

Other Developers

Total Other Developers	2

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
1.8845GM/5ML (376.9MG/ML)	**	**	-	-	-
3.769GM/10ML (376.9MG/ML)	**	**	-	-	-
5.6535GM/15ML (376.9MG/ML)	**	**	-	-	-
7.538GM/20ML (376.9MG/ML)	**	**	-	-	-
37.69GM/100ML (376.9MG/ML)	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	2

Manufacturing Details of DOTAREM