TALZENNA (nda211651)- (EQ 0.25MG BASE,EQ 1MG BASE,EQ 0.5MG BASE,EQ 0.75MG BASE,EQ 0.1MG BASE,EQ 0.35MG BASE)

Generic Name	TALAZOPARIB TOSYLATE	Innovator	PFIZER
Dosage	EQ 0.25MG BASE,EQ 1MG BASE,EQ 0.5MG BASE,EQ 0.75MG BASE,EQ 0.1MG BASE,EQ 0.35MG BASE
ParaIV Filing	No	505(b)2 Filing	No
Last Patent Expiry	2031-Oct-20	NCE Excl Expiry	2023-Oct-16
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	TALZENNA is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated for the treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) HER2-negative locally advanced or metastatic breast cancer. Select patients for therapy based on an FDA-approved companion diagnostic for TALZENNA

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 0.25MG BASE	**	**	-	-	-
EQ 1MG BASE	**	**	-	-	-
EQ 0.5MG BASE	**	**	-	-	-
EQ 0.75MG BASE	**	**	-	-	-
EQ 0.1MG BASE	**	**	-	-	-
EQ 0.35MG BASE	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	0

Manufacturing Details of TALZENNA