Details for New Drug Application (NDA): 209115

NDA 209115 describes RUBRACA, which is a drug marketed by Pharmaand and is included in one NDA. It is available from two suppliers. There are nine patents protecting this drug. Additional details are available on the RUBRACA profile page.

The generic ingredient in RUBRACA is rucaparib camsylate. Two suppliers are listed for this compound. Additional details are available on the rucaparib camsylate profile page.

Summary for 209115

Tradename:	RUBRACA
Applicant:	Pharmaand
Ingredient:	rucaparib camsylate
Patents:	9

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 209115

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for NDA: 209115

Mechanism of Action

Poly(ADP-Ribose) Polymerase Inhibitors

Suppliers and Packaging for NDA: 209115

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
RUBRACA	rucaparib camsylate	TABLET;ORAL	209115	NDA	Clovis Oncology, Inc.	69660-201	69660-201-91	60 TABLET, FILM COATED in 1 BOTTLE (69660-201-91)
RUBRACA	rucaparib camsylate	TABLET;ORAL	209115	NDA	pharmaand GmbH	82154-0783	82154-0783-1	60 TABLET, FILM COATED in 1 BOTTLE (82154-0783-1)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 200MG BASE
Approval Date:	Dec 19, 2016	TE:		RLD:	Yes
Regulatory Exclusivity Expiration:	Apr 6, 2025
Regulatory Exclusivity Use:	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
Patent:		Patent Expiration:	Aug 17, 2035	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	A METHOD FOR TREATING EPITHELIAL OVARIAN, FALLOPIAN TUBE, OR PRIMARY PERITONEAL CANCER, WHEREIN THE CANCER IS ASSOCIATED WITH A DELETERIOUS BRCA MUTATION
Patent:		Patent Expiration:	Aug 17, 2035	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	A METHOD FOR TREATING METASTATIC CASTRATION-RESISTANT PROSTATE CANCER (MCRPC), WHEREIN THE CANCER IS ASSOCIATED WITH A DELETERIOUS BRCA-MUTATION

Expired US Patents for NDA 209115

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pharmaand	RUBRACA	rucaparib camsylate	TABLET;ORAL	209115-003	May 1, 2017
Pharmaand	RUBRACA	rucaparib camsylate	TABLET;ORAL	209115-002	Dec 19, 2016
Pharmaand	RUBRACA	rucaparib camsylate	TABLET;ORAL	209115-001	Dec 19, 2016
Pharmaand	RUBRACA	rucaparib camsylate	TABLET;ORAL	209115-003	May 1, 2017
Pharmaand	RUBRACA	rucaparib camsylate	TABLET;ORAL	209115-003	May 1, 2017
Pharmaand	RUBRACA	rucaparib camsylate	TABLET;ORAL	209115-002	Dec 19, 2016
Pharmaand	RUBRACA	rucaparib camsylate	TABLET;ORAL	209115-002	Dec 19, 2016

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