EYSUVIS (nda210933)- (0.25%)

Generic Name	LOTEPREDNOL ETABONATE	Innovator	ALCON LABS INC
Dosage	0.25%
ParaIV Filing	No	505(b)2 Filing	Yes
Last Patent Expiry	2033-May-03	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	2023-Oct-26
GAIN Expiry	None	Drug Complexity	No
Indication	EYSUVIS is a corticosteroid indicated for the short-term (up to two weeks) treatment of the signs and symptoms of dry eye disease.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
0	0	0

Other Developers

Total Other Developers	2

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
0.25%	**	**	Up	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	0

Manufacturing Details of EYSUVIS