OMONTYS (nda202799)- (EQ 10MG BASE/ML (EQ 10MG BASE/ML),EQ 20MG BASE/2ML (EQ 10MG BASE/ML))

Generic Name	PEGINESATIDE ACETATE	Innovator	TAKEDA PHARMS USA
Dosage	EQ 10MG BASE/ML (EQ 10MG BASE/ML),EQ 20MG BASE/2ML (EQ 10MG BASE/ML)
ParaIV Filing	No	505(b)2 Filing	No
Last Patent Expiry	2026-Jun-02	NCE Excl Expiry	Expired
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 10MG BASE/ML (EQ 10MG BASE/ML)	**	**	-	-	-
EQ 20MG BASE/2ML (EQ 10MG BASE/ML)	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	0

Manufacturing Details of OMONTYS