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RUBRACA Drug Profile

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Which patents cover Rubraca, and when can generic versions of Rubraca launch?

Rubraca is a drug marketed by Clovis Oncology Inc and is included in one NDA. There are ten patents protecting this drug.

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

Summary for RUBRACA

US Patents:	10
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	11
Clinical Trials:	1
Patent Applications:	41
Drug Prices:	Drug price information for RUBRACA
DailyMed Link:	RUBRACA at DailyMed

Generic Entry Opportunity Date for RUBRACA

NDA:

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 RUBRACA

Drug Class	Poly(ADP-Ribose) Polymerase Inhibitor
Mechanism of Action	Poly(ADP-Ribose) Polymerase Inhibitors

Synonyms for RUBRACA

283173-50-2

6-FLUORO-2-{4-[(METHYLAMINO)METHYL]PHENYL}-3,10-DIAZATRICYCLO[6.4.1.0?,(1)(3)]TRIDECA-1,4(13),5,7-TETRAEN-9-ONE

6H-Azepino(5,4,3-cd)indol-6-one, 8-fluoro-1,3,4,5-tetrahydro-2-(4-((methylamino)methyl)phenyl)-

6H-Pyrrolo(4,3,2-ef)(2)benzazepin-6-one, 8-fluoro-1,3,4,5-tetrahydro-2-(4-((methylamino)methyl)phenyl)-

6H-Pyrrolo[4,3,2-ef][2]benzazepin-6-one,8-fluoro-1,3,4,5-tetrahydro-2-[4-[(methylamino)methyl]phenyl]-

8-FLUOR-2-{4-[(METHYLAMINO)METHYL]FENYL}-1,3,4,5-TETRAHYDRO-6HAZEPINO[5,4,3-CD]INDOOL-6-ON

8-Fluoro-1,3,4,5-tetrahydro-2-[4-[(methylamino)methyl]phenyl]-6H-pyrrolo[4,3,2-ef][2]benzazepin-6-one

8-Fluoro-2-(4-((methylamino)methyl)phenyl)-1,3,4,5-tetrahydro-6H-azepino(5,4,3-cd)indol-6-one

8-FLUORO-2-(4-((METHYLAMINO)METHYL)PHENYL)-4,5-DIHYDRO-1H-AZEPINO[5,4,3-CD]INDOL-6(3H)-ONE

8-fluoro-2-(4-methylaminomethyl-phenyl)-1,3,4,5-tetrahydro-azepino[5,4,3-cd]indol-6-one

8-Fluoro-2-[4-[(methylamino)methyl]phenyl]-1,3,4,5-tetrahydro-6H-azepino[5,4,3-cd]indol-6-one

8-fluoro-2-{4-[(methylamino)methyl]phenyl}-1,3,4,5-tetrahydro-6H-azepino[5,4,3-cd]indol-6-one

8237F3U7EH

AC-24390

AG 014699

AG-14447

AG14447

AK317822

AKOS015898427

BDBM50446130

BRD-K88560311-011-01-4

CHEBI:134689

CHEBI:94311

CHEMBL1173055

CS-2785

CTK4G1217

D01SHZ

D10079

DB12332

DTXSID10182563

FT-0696622

GTPL7736

HMABYWSNWIZPAG-UHFFFAOYSA-N

HY-10617A

I10-0690

KB-73984

Kinome_3180

MolPort-028-744-762

NCGC00263173-01

NCGC00263173-03

PF 01367338

PF01367338

PL006099

RPB

Rubraca (TN)

RUCAPARIB

Rucaparib (free base)

Rucaparib (USAN/INN)

Rucaparib [USAN:INN]

Rucaparib(AG-014447)

SCHEMBL844585

Tube725

UNII-8237F3U7EH

Z-3241

ZINC25958

US Patents and Regulatory Information for RUBRACA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Clovis Oncology Inc	RUBRACA	rucaparib camsylate	TABLET;ORAL	209115-002	Dec 19, 2016		RX	Yes	Yes			Y
Clovis Oncology Inc	RUBRACA	rucaparib camsylate	TABLET;ORAL	209115-003	May 1, 2017		RX	Yes	No
Clovis Oncology Inc	RUBRACA	rucaparib camsylate	TABLET;ORAL	209115-003	May 1, 2017		RX	Yes	No			Y	Y
Clovis Oncology Inc	RUBRACA	rucaparib camsylate	TABLET;ORAL	209115-003	May 1, 2017		RX	Yes	No
Clovis Oncology Inc	RUBRACA	rucaparib camsylate	TABLET;ORAL	209115-003	May 1, 2017		RX	Yes	No

International Patents for RUBRACA

Country	Document Number	Estimated Expiration
Bulgaria	65210
Hungary	E025996
European Patent Office	1649017
Norway	2015008
Norway	320343

Supplementary Protection Certificates for RUBRACA

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
C0022	France		PRODUCT NAME: OLAPARIB,SELS ET SOLVATES DE CELUI-CI; REGISTRATION NO/DATE: EU 1/14/959 20141218
15/016	Ireland		PRODUCT NAME: OLAPARIB, AND SALTS AND SOLVATES THEREOF; REGISTRATION NO/DATE: EU/1/14/959/001 20141216
500012	Hungary		PRODUCT NAME: OLAPARIB
2015016	Lithuania		PRODUCT NAME: OLAPARIBUM; REGISTRATION NO/DATE: EU/1/14/959 20141216
00726	Netherlands		PRODUCT NAME: OLAPARIB, EN ZOUTEN EN; REGISTRATION NO/DATE: EU/1/14/959/001 20141216