OPZELURA (nda215309)- (EQ 1.5% BASE)

Generic Name	RUXOLITINIB PHOSPHATE	Innovator	INCYTE CORP
Dosage	EQ 1.5% BASE
ParaIV Filing	Yes	505(b)2 Filing	No
Last Patent Expiry	2041-May-05	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	2024-Sep-21
GAIN Expiry	None	Drug Complexity	No
Indication	OPZELURA is a Janus kinase (JAK) inhibitor indicated for: • the topical short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis in non-immunocompromised adult and pediatric patients 12 years of age and older whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. • the topical treatment of nonsegmental vitiligo in adult and pediatric patients 12 years of age and older.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
0	0	0

Other Developers

Total Other Developers	8

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
EQ 1.5% BASE	**	**	Up	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	0

Manufacturing Details of OPZELURA