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RUBRACA Drug Profile

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When do Rubraca patents expire, and what generic alternatives are available?

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

This drug has two hundred and twenty-six patent family members in fifty-two countries.

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

International Patents:	226
US Patents:	9
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	6
Clinical Trials:	1
Patent Applications:	41
Drug Prices:	see details
DailyMed Link:	RUBRACA at DailyMed

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
Clovis Oncology Inc	RUBRACA	rucaparib camsylate	TABLET;ORAL	209115-002	Dec 19, 2016		RX	Yes	Yes
Clovis Oncology Inc	RUBRACA	rucaparib camsylate	TABLET;ORAL	209115-002	Dec 19, 2016		RX	Yes	Yes
Clovis Oncology Inc	RUBRACA	rucaparib camsylate	TABLET;ORAL	209115-002	Dec 19, 2016		RX	Yes	Yes			Y	Y

Non-Orange Book US Patents for RUBRACA

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
7,449,464	Phthalazinone derivatives
7,662,818	Phthalazinone derivatives
7,981,889	Phthalazinone derivatives
6,977,298	Tricyclic inhibitors of poly(ADP-ribose) polymerases

International Patents for RUBRACA

Country	Document Number	Estimated Expiration
Japan	2016216507
Slovenia	2534153
Lithuania	4936
Poland	1684736

Supplementary Protection Certificates for RUBRACA

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
90019-4	Sweden		PRODUCT NAME: OLAPARIB, AND SALTS AND SOLVATES THEREOF; REG. NO/DATE: EU/1/14/959 20141218
00726	Netherlands		PRODUCT NAME: OLAPARIB, EN ZOUTEN EN; REGISTRATION NO/DATE: EU/1/14/959/001 20141216
/2015	Austria		PRODUCT NAME: OLAPARIB UND SALZE UND SOLVATE DAVON; REGISTRATION NO/DATE: EU/1/14/959 20141216
3 50005-2015	Slovakia		PRODUCT NAME: OLAPARIB; REGISTRATION NO/DATE: EU/1/14/959 20141218