MIRAPEX ER (nda022421)- (0.375MG,0.75MG,1.5MG,2.25MG,3MG,3.75MG,4.5MG)

Generic Name	PRAMIPEXOLE DIHYDROCHLORIDE	Innovator	BOEHRINGER INGELHEIM
Dosage	0.375MG,0.75MG,1.5MG,2.25MG,3MG,3.75MG,4.5MG
ParaIV Filing	Yes	505(b)2 Filing	No
Last Patent Expiry	2029-Sep-08	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	MIRAPEX ER is a non-ergot dopamine agonist indicated for the treatment of Parkinson’s disease (PD).

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
10	0	6

Other Developers

Total Other Developers	4

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
0.375MG	**	**	Up	-	5
0.75MG	**	**	Up	-	5
1.5MG	**	**	Up	-	4
2.25MG	**	**	-	-	3
3MG	**	**	Up	-	4
3.75MG	**	**	-	-	3
4.5MG	**	**	Up	-	4

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	4

Manufacturing Details of MIRAPEX ER