XDEMVY (NDA217603)- (0.25%)

Generic Name	LOTILANER	Innovator	TARSUS
Dosage	0.25%
ParaIV Filing	No	505(b)2 Filing	No
Last Patent Expiry	2038-Dec-14	NCE Excl Expiry	2028-Jul-24
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	XDEMVY is an ectoparasiticide (anti-parasitic) indicated for the treatment of Demodex blepharitis.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
0	0	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
0.25%	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	0

Manufacturing Details of XDEMVY