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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 twelve patents protecting this drug.

This drug has two hundred and sixty-eight 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

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Summary for RUBRACA

International Patents:	268
US Patents:	12
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	53
Clinical Trials:	15
Patent Applications:	63
Drug Prices:	Drug price information for RUBRACA
DailyMed Link:	RUBRACA at DailyMed

Drug patent expirations by year for RUBRACA

Generic Entry Opportunity Date for RUBRACA

Generic Entry Date for RUBRACA^: Start Trial* Constraining patent/regulatory exclusivity: Start Trial 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
The Miriam Hospital	Phase 1/Phase 2
Bayer	Phase 1/Phase 2
Brown University	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
6-fluoro-2-[4-(methylaminomethyl)phenyl]-3,10-diazatricyclo[6.4.1.0^{4,13]trideca-1,4,6,8(13)-tetraen-9-one
6-fluoro-2-{4-[(methylamino)methyl]phenyl}-3,10-diazatricyclo[6.4.1.0?,(1)(3)]trideca-1,4,6,8(13)-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]
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
A14182
AC-24390
AG-14447
AG14447
AK317822
AKOS015898427
AS-74779
BCP07633
BDBM50446130
BRD-K88560311-011-01-4
C19H18FN3O
CHEBI:134689
CHEBI:94311
CHEMBL1173055
CS-2785
CTK4G1217
D10079
DB12332
DTXSID10182563
EX-A2700
FT-0696622
GTPL7736
HMABYWSNWIZPAG-UHFFFAOYSA-N
HY-10617A
Kinome_3180
NCGC00263173-01
NCGC00263173-03
NCGC00263173-13
Q7376558
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

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Glossary

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

International Patents for RUBRACA

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Country	Patent Number	Estimated Expiration
United Kingdom	0603874	Start Trial
Hungary	0105414	Start Trial
European Patent Office	2305221	Start Trial
>Country	>Patent Number	>Estimated Expiration

Supplementary Protection Certificates for RUBRACA

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2534153	C20180033 00273	Estonia	Start Trial	PRODUCT NAME: RUKAPARIIB;REG NO/DATE: EU/1/17/1250 29.05.2018
1633724	13/2015	Austria	Start Trial	PRODUCT NAME: OLAPARIB UND SALZE UND SOLVATE DAVON; REGISTRATION NO/DATE: EU/1/14/959 20141216
1633724	C20150012 00136	Estonia	Start Trial	PRODUCT NAME: OLAPARIIB;REG NO/DATE: EU/1/14/959 18.12.2014
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description