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Last Updated: January 19, 2021

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rubraca Drug Profile

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US ANDA Litigation and Generic Entry Outlook for Rubraca

Rubraca was eligible for patent challenges on December 19, 2020.

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

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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
Rhode Island HospitalPhase 1/Phase 2
The Miriam HospitalPhase 1/Phase 2
BayerPhase 1/Phase 2

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Pharmacology for rubraca

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 209115-003 May 1, 2017 RX Yes No   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 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 209115-003 May 1, 2017 RX Yes No   Start Trial   Start Trial Y 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

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 209115-002 Dec 19, 2016   Start Trial   Start Trial
Clovis Oncology Inc RUBRACA rucaparib camsylate TABLET;ORAL 209115-003 May 1, 2017   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
1633724 C 2015 011 Romania   Start Trial PRODUCT NAME: OLAPARIB; NATIONAL AUTHORISATION NUMBER: EU/1/14/959/001; DATE OF NATIONAL AUTHORISATION: 20141216; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/14/959/001; DATE OF FIRST AUTHORISATION IN EEA: 20141216
2534153 1890042-3 Sweden   Start Trial PRODUCT NAME: RUCAPARIB CAMSYLATE; REG. NO/DATE: EU/1/17/1250 20180529
1633724 122015000025 Germany   Start Trial PRODUCT NAME: OLAPARIB, SOWIE SALZE UND SOLVATE DAVON; REGISTRATION NO/DATE: EU/1/14/959/001 20141216
1633724 92680 Luxembourg   Start Trial PRODUCT NAME: OLAPARIB AINSI QUE DES SELS ET DES SOLVATES DE CELUI-CI. FIRST REGISTRATION: 20141218
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Colorcon
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Harvard Business School
McKesson
Merck

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 verification 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.