EMPAVELI (nda215014)- (1080MG/20ML (54MG/ML))

Generic Name	PEGCETACOPLAN	Innovator	APELLIS PHARMS
Dosage	1080MG/20ML (54MG/ML)
ParaIV Filing	No	505(b)2 Filing	No
Last Patent Expiry	2038-Dec-09	NCE Excl Expiry	2026-May-14
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	EMPAVELI is a complement inhibitor indicated for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH).

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
1080MG/20ML (54MG/ML)	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	0

Manufacturing Details of EMPAVELI