RUBRACA (nda209115)- (EQ 200MG BASE,EQ 300MG BASE,EQ 250MG BASE)

Generic Name	RUCAPARIB CAMSYLATE	Innovator	PHARMAAND
Dosage	EQ 200MG BASE,EQ 300MG BASE,EQ 250MG BASE
ParaIV Filing	No	505(b)2 Filing	No
Last Patent Expiry	2035-Aug-17	NCE Excl Expiry	2021-Dec-19
ODE Expiry	2023-Dec-19	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	RUBRACA is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated: Ovarian cancer • for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. Prostate cancer • for the treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for RUBRACA.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
0	0	0

Other Developers

Total Other Developers	1

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
EQ 200MG BASE	**	**	-	-	-
EQ 300MG BASE	**	**	-	-	-
EQ 250MG BASE	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	0

Manufacturing Details of RUBRACA