ADLARITY (nda212304)- (5MG/DAY,10MG/DAY)

Generic Name	DONEPEZIL HYDROCHLORIDE	Innovator	CORIUM
Dosage	5MG/DAY,10MG/DAY
ParaIV Filing	No	505(b)2 Filing	Yes
Last Patent Expiry	2038-Aug-11	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	2025-Mar-11
GAIN Expiry	None	Drug Complexity	No
Indication	ADLARITY is an acetylcholinesterase inhibitor indicated for the treatment of mild, moderate, and severe dementia of the Alzheimer’s type.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
0	0	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
5MG/DAY	**	**	-	-	-
10MG/DAY	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	0

Manufacturing Details of ADLARITY