ALYFTREK (NDA218730)- (50MG;20MG;EQ 4MG BASE,125MG;50MG;EQ 10MG BASE)

Generic Name	DEUTIVACAFTOR; TEZACAFTOR; VANZACAFTOR CALCIUM	Innovator	VERTEX PHARMS INC
Dosage	50MG;20MG;EQ 4MG BASE,125MG;50MG;EQ 10MG BASE
ParaIV Filing	No	505(b)2 Filing	No
Last Patent Expiry	2040-Aug-13	NCE Excl Expiry	2029-Dec-20
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	ALYFTREK is a combination of deutivacaftor, a CFTR potentiator, tezacaftor, and vanzacaftor indicated for the treatment of cystic fibrosis (CF) in patients aged 6 years and older who have at least one F508del mutation or another responsive mutation in the CFTR gene. If the patient’s genotype is unknown, an FDA-cleared CF mutation test should be used to confirm the presence of at least one indicated mutation.

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
50MG;20MG;EQ 4MG BASE	**	**	-	-	-
125MG;50MG;EQ 10MG BASE	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	0

Manufacturing Details of ALYFTREK