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Last Updated: February 16, 2020

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RUBRACA Drug Profile


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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
Drug patent expirations by year for RUBRACA
Drug Prices for RUBRACA

See drug prices for RUBRACA

Generic Entry Opportunity Date for RUBRACA
Generic Entry Date for RUBRACA*:
Constraining patent/regulatory exclusivity:
NDA:
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

SponsorPhase
Bristol-Myers SquibbPhase 1/Phase 2
Anwaar SaeedPhase 1/Phase 2
Clovis Oncology, Inc.Phase 1/Phase 2

See all RUBRACA clinical trials

Pharmacology for RUBRACA
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   Start Trial   Start Trial Y   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 209115-003 May 1, 2017 RX Yes No   Start Trial   Start Trial Y Y   Start Trial
Clovis Oncology Inc RUBRACA rucaparib camsylate TABLET;ORAL 209115-002 Dec 19, 2016 RX Yes Yes   Start Trial   Start Trial   Start Trial
Clovis Oncology Inc RUBRACA rucaparib camsylate TABLET;ORAL 209115-001 Dec 19, 2016 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   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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

Supplementary Protection Certificates for RUBRACA

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

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Serving leading biopharmaceutical companies globally:

Harvard Business School
Merck
Medtronic
Express Scripts
Baxter
Dow

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.