VYZULTA (nda207795)- (0.024%)

Generic Name	LATANOPROSTENE BUNOD	Innovator	BAUSCH AND LOMB
Dosage	0.024%
ParaIV Filing	Yes	505(b)2 Filing	No
Last Patent Expiry	2029-Feb-21	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	VYZULTA is a prostaglandin analog indicated for the reduction of intraocular pressure in patients with open-angle glaucoma or ocular hypertension.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
0	1	0

Other Developers

Total Other Developers	17

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
0.024%	**	**	Up	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	0

Manufacturing Details of VYZULTA