OMONTYS PRESERVATIVE FREE (nda202799)- (EQ 1MG BASE/0.5ML (EQ 1MG BASE/0.5ML),EQ 2MG BASE/0.5ML (EQ 2MG BASE/0.5ML),EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML),EQ 4MG BASE/0.5ML (EQ 4MG BASE/0.5ML),EQ 5MG BASE/0.5ML (EQ 5MG BASE/0.5ML),EQ 6MG BASE/0.5ML (EQ 6MG BASE/0.5ML))

Generic Name	PEGINESATIDE ACETATE	Innovator	TAKEDA PHARMS USA
Dosage	EQ 1MG BASE/0.5ML (EQ 1MG BASE/0.5ML),EQ 2MG BASE/0.5ML (EQ 2MG BASE/0.5ML),EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML),EQ 4MG BASE/0.5ML (EQ 4MG BASE/0.5ML),EQ 5MG BASE/0.5ML (EQ 5MG BASE/0.5ML),EQ 6MG BASE/0.5ML (EQ 6MG BASE/0.5ML)
ParaIV Filing	No	505(b)2 Filing	No
Last Patent Expiry	2026-Jun-02	NCE Excl Expiry	2017-Mar-27
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	OMONTYS is an erythropoiesis-stimulating agent (ESA) indicated for the treatment of anemia due to chronic kidney disease (CKD) in adult patients on dialysis.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
0	0	0

Other Developers

Total Other Developers	None

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
EQ 1MG BASE/0.5ML (EQ 1MG BASE/0.5ML)	**	**	-	-	-
EQ 2MG BASE/0.5ML (EQ 2MG BASE/0.5ML)	**	**	-	-	-
EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML)	**	**	-	-	-
EQ 4MG BASE/0.5ML (EQ 4MG BASE/0.5ML)	**	**	-	-	-
EQ 5MG BASE/0.5ML (EQ 5MG BASE/0.5ML)	**	**	-	-	-
EQ 6MG BASE/0.5ML (EQ 6MG BASE/0.5ML)	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	0

Manufacturing Details of OMONTYS PRESERVATIVE FREE