REQUIP XL (nda022008)- (EQ 2MG BASE,EQ 3MG BASE,EQ 4MG BASE,EQ 8MG BASE,EQ 12MG BASE,EQ 6MG BASE)

Generic Name	ROPINIROLE HYDROCHLORIDE	Innovator	GLAXOSMITHKLINE LLC
Dosage	EQ 2MG BASE,EQ 3MG BASE,EQ 4MG BASE,EQ 8MG BASE,EQ 12MG BASE,EQ 6MG BASE
ParaIV Filing	Yes	505(b)2 Filing	No
Last Patent Expiry	2021-Dec-02	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	REQUIP XL is a non-ergoline dopamine agonist indicated for the treatment of Parkinson’s disease.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
6	0	5

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 2MG BASE	**	**	-	4	-
EQ 3MG BASE	**	**	-	-	-
EQ 4MG BASE	**	**	-	4	-
EQ 8MG BASE	**	**	-	4	-
EQ 12MG BASE	**	**	-	4	-
EQ 6MG BASE	**	**	-	4	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	4

Manufacturing Details of REQUIP XL