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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 twelve patents protecting this drug.

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

US ANDA Litigation and Generic Entry Outlook for Rubraca

Rubraca will be eligible for patent challenges on December 19, 2020. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be August 17, 2035. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for RUBRACA

International Patents:	256
US Patents:	12
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	52
Clinical Trials:	14
Patent Applications:	63
Drug Prices:	Drug price information for RUBRACA
DailyMed Link:	RUBRACA at DailyMed

See drug prices for RUBRACA

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.

Recent Clinical Trials for RUBRACA

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Bristol-Myers Squibb	Phase 1/Phase 2
Anwaar Saeed	Phase 1/Phase 2
Clovis Oncology, Inc.	Phase 1/Phase 2

See all RUBRACA clinical trials

Pharmacology for RUBRACA

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

Synonyms for RUBRACA

283173-50-2

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

BCP07633

BDBM50446130

BRD-K88560311-011-01-4

CHEBI:134689

CHEBI:94311

CHEMBL1173055

CS-2785

CTK4G1217

D10079

DB12332

DTXSID10182563

EX-A2700

FT-0696622

GTPL7736

HMABYWSNWIZPAG-UHFFFAOYSA-N

HY-10617A

I10-0690

KB-73984

Kinome_3180

MolPort-028-744-762

NCGC00263173-01

NCGC00263173-03

NCGC00263173-13

PF 01367338

RPB

RUCAPARIB

Rucaparib (free base)

Rucaparib (USAN/INN)

Rucaparib [USAN:INN]

Rucaparib; AG 014699; PF-01367338

Rucaparib(AG-014447)

SB16538

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	209115-002	Dec 19, 2016		RX	Yes	Yes
Clovis Oncology Inc	RUBRACA	rucaparib camsylate	TABLET;ORAL	209115-001	Dec 19, 2016		RX	Yes	No
Clovis Oncology Inc	RUBRACA	rucaparib camsylate	TABLET;ORAL	209115-002	Dec 19, 2016		RX	Yes	Yes

Expired US Patents for RUBRACA

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

International Patents for RUBRACA

Country	Patent Number	Estimated Expiration
Russian Federation	2006121459
Mexico	PA06006120
Germany	602004032537
Taiwan	201144316
Spain	2364140
Norway	2018039

Supplementary Protection Certificates for RUBRACA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2534153	300958	Netherlands		PRODUCT NAME: RUCAPARIB CAMSYLAAT; REGISTRATION NO/DATE: EU/1/17/1250 20180529
1633724	15C0022	France		PRODUCT NAME: OLAPARIB,SELS ET SOLVATES DE CELUI-CI; REGISTRATION NO/DATE: EU 1/14/959 20141218
1633724	CR 2015 00012	Denmark		PRODUCT NAME: OLAPARIB, OG SALTE OG SOLVATER DERAF; REG. NO/DATE: EU/1/14/959/001 20141216
1633724	PA2015016,C1633724	Lithuania		PRODUCT NAME: OLAPARIBAS IR JO DRUSKOS IR SOLVATAI; REGISTRATION NO/DATE: EU/1/14/959 20141216
1633724	C01633724/01	Switzerland		PRODUCT NAME: OLAPARIB; REGISTRATION NO/DATE: SWISSMEDIC 65160 14.01.2016
2534153	122018000131	Germany		PRODUCT NAME: RUCAPARIB CAMSYLAT; REGISTRATION NO/DATE: EU/1/17/1250 20180524