Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Serving leading biopharmaceutical companies globally:

Merck
Express Scripts
Harvard Business School
McKesson
Boehringer Ingelheim
McKinsey

Last Updated: October 15, 2019

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RUBRACA Drug Profile

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Summary for RUBRACA
Drug patent expirations by year for RUBRACA
Drug Prices for RUBRACA

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

Supplementary Protection Certificates for RUBRACA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1633724 C20150012 00136 Estonia   See Pricing PRODUCT NAME: OLAPARIIB;REG NO/DATE: EU/1/14/959 18.12.2014
1633724 C01633724/01 Switzerland   See Pricing PRODUCT NAME: OLAPARIB; REGISTRATION NO/DATE: SWISSMEDIC 65160 14.01.2016
2534153 CA 2018 00041 Denmark   See Pricing PRODUCT NAME: RUCAPARIB CAMSYLATE; REG. NO/DATE: EU/1/17/1250/001-003 20180529
2534153 PA2018517 Lithuania   See Pricing PRODUCT NAME: RUKAPARIBO KAMSILATAS; 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:

Baxter
McKesson
Mallinckrodt
Johnson and Johnson
AstraZeneca
Colorcon

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.