PYRUKYND (nda216196)- (EQ 5MG BASE,EQ 20MG BASE,EQ 50MG BASE)

Generic Name	MITAPIVAT SULFATE	Innovator	AGIOS PHARMS INC
Dosage	EQ 5MG BASE,EQ 20MG BASE,EQ 50MG BASE
ParaIV Filing	No	505(b)2 Filing	No
Last Patent Expiry	2041-Jul-31	NCE Excl Expiry	2027-Feb-17
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	PYRUKYND is a pyruvate kinase activator indicated for the treatment of hemolytic anemia in adults with pyruvate kinase (PK) deficiency.

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 5MG BASE	**	**	-	-	-
EQ 20MG BASE	**	**	-	-	-
EQ 50MG BASE	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	0

Manufacturing Details of PYRUKYND