GIMOTI (nda209388)- (EQ 15MG BASE/SPRAY)

Generic Name	METOCLOPRAMIDE HYDROCHLORIDE	Innovator	EVOKE PHARMA INC
Dosage	EQ 15MG BASE/SPRAY
ParaIV Filing	Yes	505(b)2 Filing	Yes
Last Patent Expiry	2030-May-16	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	2023-Jun-19
GAIN Expiry	None	Drug Complexity	No
Indication	GIMOTI is a dopamine-2 (D2) antagonist indicated for the relief of symptoms in adults with acute and recurrent diabetic gastroparesis.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
0	1	0

Other Developers

Total Other Developers	1

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
EQ 15MG BASE/SPRAY	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	0

Manufacturing Details of GIMOTI