ACCUTANE (nda018662)- (10MG,20MG,40MG)

Generic Name	ISOTRETINOIN	Innovator	HOFFMANN LA ROCHE
Dosage	10MG,20MG,40MG
ParaIV Filing	No	505(b)2 Filing	No
Last Patent Expiry	2002-Feb-07	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	Accutane is indicated for the treatment of severe recalcitrant nodular acne.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
7	0	7

Other Developers

Total Other Developers	None

Drugs with Suitability

Drugs with Suitability	Yes

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
10MG	**	**	-	-	6
20MG	**	**	-	-	6
40MG	**	**	-	-	6

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	7

Manufacturing Details of ACCUTANE