PICATO (nda202833)- (0.015%,0.05%)

Generic Name	INGENOL MEBUTATE	Innovator	LEO LABS
Dosage	0.015%,0.05%
ParaIV Filing	Yes	505(b)2 Filing	No
Last Patent Expiry	2033-May-15	NCE Excl Expiry	2017-Jan-23
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	Picato gel is an inducer of cell death indicated for the topical treatment of actinic keratosis.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
0	2	0

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
0.015%	**	**	-	-	-
0.05%	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	0

Manufacturing Details of PICATO