TYRVAYA (nda213978)- (EQ 0.03MG BASE/SPRAY)

Generic Name	VARENICLINE TARTRATE	Innovator	OYSTER POINT PHARMA
Dosage	EQ 0.03MG BASE/SPRAY
ParaIV Filing	Yes	505(b)2 Filing	No
Last Patent Expiry	2035-Oct-19	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	2024-Oct-15
GAIN Expiry	None	Drug Complexity	No
Indication	TYRVAYA (varenicline solution) nasal spray is a cholinergic agonist indicated for the 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	4

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
EQ 0.03MG BASE/SPRAY	**	**	Up	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	0

Manufacturing Details of TYRVAYA