MIRAPEX (nda020667)- (0.125MG,0.25MG,0.5MG,0.75MG,1MG,1.25MG,1.5MG)

Generic Name	PRAMIPEXOLE DIHYDROCHLORIDE	Innovator	BOEHRINGER INGELHEIM
Dosage	0.125MG,0.25MG,0.5MG,0.75MG,1MG,1.25MG,1.5MG
ParaIV Filing	Yes	505(b)2 Filing	No
Last Patent Expiry	2018-Jan-16	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	MIRAPEX is a non-ergot dopamine agonist indicated for the treatment of: • Parkinson’s disease (PD) • Moderate-to-severe primary Restless Legs Syndrome (RLS).

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
8	0	6

Other Developers

Total Other Developers	6

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
0.125MG	**	**	-	-	5
0.25MG	**	**	-	5	-
0.5MG	**	**	-	4	-
0.75MG	**	**	-	-	2
1MG	**	**	-	4	-
1.25MG	**	**	-	-	-
1.5MG	**	**	-	4	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	6

Manufacturing Details of MIRAPEX