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Last Updated: April 22, 2024

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RUBRACA Drug Patent Profile


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Which patents cover Rubraca, and when can generic versions of Rubraca launch?

Rubraca is a drug marketed by Zr Pharma and is included in one NDA. There are eleven patents protecting this drug.

This drug has two hundred and thirty-one patent family members in forty-two countries.

The generic ingredient in RUBRACA is rucaparib camsylate. Two suppliers are listed for this compound. Additional details are available on the rucaparib camsylate profile page.

DrugPatentWatch® 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.

There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Drug patent expirations by year for RUBRACA
Drug Prices for RUBRACA

See drug prices for RUBRACA

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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
Brown UniversityPhase 1/Phase 2
BayerPhase 1/Phase 2

See all RUBRACA clinical trials

Pharmacology for RUBRACA

US Patents and Regulatory Information for RUBRACA

RUBRACA is protected by twenty-five US patents and one FDA Regulatory Exclusivity.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of RUBRACA is ⤷  Try a Trial.

This potential generic entry date is based on patent ⤷  Try a Trial.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting RUBRACA

High dosage strength tablets of rucaparib
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: A METHOD FOR TREATING EPITHELIAL OVARIAN, FALLOPIAN TUBE, OR PRIMARY PERITONEAL CANCER, WHEREIN THE CANCER IS ASSOCIATED WITH A DELETERIOUS BRCA MUTATION

High dosage strength tablets of rucaparib
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: MAINTENANCE TREATMENT OF RECURRENT EPITHELIAL OVARIAN, FALLOPIAN TUBE OR PRIMARY PERITONEAL CANCER, WHO ARE IN A COMPLETE OR PARTIAL RESPONSE TO PLATINUM-BASED CHEMOTHERAPY

High dosage strength tablets of rucaparib
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: A METHOD FOR TREATING OVARIAN CANCER BY ADMINISTERING RUCAPARIB, WHEREIN THE CANCER IS ASSOCIATED WITH A DELETERIOUS BRCA MUTATION

High dosage strength tablets of rucaparib
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: A METHOD FOR TREATING METASTATIC CASTRATION-RESISTANT PROSTATE CANCER (MCRPC), WHEREIN THE CANCER IS ASSOCIATED WITH A DELETERIOUS BRCA-MUTATION

Salts and polymorphs of 8-fluoro-2-{4-[(methylamino)methyl]phenyl}-1,3,4,5-tetrahydro-6H-azepino[- 5,4,3-cd]indol-6-one
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Therapeutic compounds
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: A METHOD FOR TREATING OVARIAN CANCER BY ADMINISTERING RUCAPARIB, WHEREIN THE CANCER IS ASSOCIATED WITH A DELETERIOUS BRCA MUTATION

Therapeutic compounds
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: A METHOD FOR TREATING EPITHELIAL OVARIAN, FALLOPIAN TUBE, OR PRIMARY PERITONEAL CANCER, WHEREIN THE CANCER IS ASSOCIATED WITH A DELETERIOUS BRCA MUTATION

Therapeutic compounds
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: A METHOD FOR TREATING METASTATIC CASTRATION-RESISTANT PROSTATE CANCER (MCRPC), WHEREIN THE CANCER IS ASSOCIATED WITH A DELETERIOUS BRCA-MUTATION

Therapeutic compounds
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: A METHOD FOR TREATING EPITHELIAL OVARIAN, FALLOPIAN TUBE, OR PRIMARY PERITONEAL CANCER, WHEREIN THE CANCER IS ASSOCIATED WITH A DELETERIOUS BRCA MUTATION

Therapeutic compounds
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: A METHOD FOR TREATING OVARIAN CANCER BY ADMINISTERING RUCAPARIB, WHEREIN THE CANCER IS ASSOCIATED WITH A DELETERIOUS BRCA MUTATION

Therapeutic compounds
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: A METHOD FOR TREATING METASTATIC CASTRATION-RESISTANT PROSTATE CANCER (MCRPC), WHEREIN THE CANCER IS ASSOCIATED WITH A DELETERIOUS BRCA-MUTATION

DNA damage repair inhibitors for the treatment of cancer
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: A METHOD FOR TREATING EPITHELIAL OVARIAN, FALLOPIAN TUBE, OR PRIMARY PERITONEAL CANCER, WHEREIN THE CANCER IS ASSOCIATED WITH A DELETERIOUS BRCA MUTATION

DNA damage repair inhibitors for the treatment of cancer
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: A METHOD FOR TREATING OVARIAN CANCER BY ADMINISTERING RUCAPARIB, WHEREIN THE CANCER IS ASSOCIATED WITH A DELETERIOUS BRCA MUTATION

DNA damage repair inhibitors for the treatment of cancer
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: A METHOD FOR TREATING METASTATIC CASTRATION-RESISTANT PROSTATE CANCER (MCRPC), WHEREIN THE CANCER IS ASSOCIATED WITH A DELETERIOUS BRCA-MUTATION

DNA damage repair inhibitors for treatment of cancer
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: A METHOD FOR TREATING OVARIAN CANCER BY ADMINISTERING RUCAPARIB, WHEREIN THE CANCER IS ASSOCIATED WITH A DELETERIOUS BRCA MUTATION

DNA damage repair inhibitors for treatment of cancer
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: A METHOD FOR TREATING EPITHELIAL OVARIAN, FALLOPIAN TUBE, OR PRIMARY PERITONEAL CANCER, WHEREIN THE CANCER IS ASSOCIATED WITH A DELETERIOUS BRCA MUTATION

DNA damage repair inhibitors for treatment of cancer
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: A METHOD FOR TREATING METASTATIC CASTRATION-RESISTANT PROSTATE CANCER (MCRPC), WHEREIN THE CANCER IS ASSOCIATED WITH A DELETERIOUS BRCA-MUTATION

Salts and polymorphs of 8-fluoro-2-{4-[(methylamino)methyl]phenyl}-1,3,4,5-tetrahydro-6h-azepino[- 5,4,3-cd]indol-6-one
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Use of RNAI inhibiting PARP activity for the manufacture of a medicament for the treatment of cancer
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: A METHOD FOR TREATING OVARIAN CANCER BY ADMINISTERING RUCAPARIB, WHEREIN THE CANCER IS ASSOCIATED WITH A DELETERIOUS BRCA MUTATION

Use of RNAI inhibiting PARP activity for the manufacture of a medicament for the treatment of cancer
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: A METHOD FOR TREATING EPITHELIAL OVARIAN, FALLOPIAN TUBE, OR PRIMARY PERITONEAL CANCER, WHEREIN THE CANCER IS ASSOCIATED WITH A DELETERIOUS BRCA MUTATION

Use of RNAI inhibiting PARP activity for the manufacture of a medicament for the treatment of cancer
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: A METHOD FOR TREATING METASTATIC CASTRATION-RESISTANT PROSTATE CANCER (MCRPC), WHEREIN THE CANCER IS ASSOCIATED WITH A DELETERIOUS BRCA-MUTATION

Salts and polymorphs of 8-fluoro-2-{4-[(methylamino)methyl]phenyl}-1,3,4,5-tetrahydro-6H-azepino[- 5,4,3-cd]indol-6-one
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Salts and polymorphs of 8-fluoro-2-{4-[(methylamino)methyl]phenyl}-1,3,4,5-tetrahydro-6H-azepino[- 5,4,3-cd]indol-6-one
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: A METHOD FOR TREATING OVARIAN CANCER BY ADMINISTERING RUCAPARIB, WHEREIN THE CANCER IS ASSOCIATED WITH A DELETERIOUS BRCA MUTATION

Salts and polymorphs of 8-fluoro-2-{4-[(methylamino)methyl]phenyl}-1,3,4,5-tetrahydro-6H-azepino[- 5,4,3-cd]indol-6-one
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: A METHOD FOR TREATING EPITHELIAL OVARIAN, FALLOPIAN TUBE, OR PRIMARY PERITONEAL CANCER, WHEREIN THE CANCER IS ASSOCIATED WITH A DELETERIOUS BRCA MUTATION

High dosage strength tablets of rucaparib
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

FDA Regulatory Exclusivity protecting RUBRACA

FOR THE MAINTENANCE TREATMENT OF ADULT PATIENTS WITH RECURRENT EPITHELIAL OVARIAN, FALLOPIAN TUBE, OR PRIMARY PERITONEAL CANCER WHO ARE IN A COMPLETE OR PARTIAL RESPONSE TO PLATINUM-BASED CHEMOTHERAPY
Exclusivity Expiration: ⤷  Try a Trial

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

International Patents for RUBRACA

When does loss-of-exclusivity occur for RUBRACA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Patent: 15305696
Estimated Expiration: ⤷  Try a Trial

Patent: 19272064
Estimated Expiration: ⤷  Try a Trial

Brazil

Patent: 2017000865
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 55495
Estimated Expiration: ⤷  Try a Trial

China

Patent: 6794185
Estimated Expiration: ⤷  Try a Trial

Patent: 3209033
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 82975
Estimated Expiration: ⤷  Try a Trial

Israel

Patent: 9946
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 74477
Estimated Expiration: ⤷  Try a Trial

Patent: 97980
Estimated Expiration: ⤷  Try a Trial

Patent: 27101
Estimated Expiration: ⤷  Try a Trial

Patent: 17525712
Estimated Expiration: ⤷  Try a Trial

Patent: 20002149
Estimated Expiration: ⤷  Try a Trial

Patent: 21038242
Estimated Expiration: ⤷  Try a Trial

Mexico

Patent: 7260
Estimated Expiration: ⤷  Try a Trial

Patent: 17001540
Estimated Expiration: ⤷  Try a Trial

New Zealand

Patent: 8392
Estimated Expiration: ⤷  Try a Trial

Russian Federation

Patent: 05156
Estimated Expiration: ⤷  Try a Trial

Patent: 17109139
Estimated Expiration: ⤷  Try a Trial

Singapore

Patent: 201700265V
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 170043597
Estimated Expiration: ⤷  Try a Trial

Patent: 230097211
Estimated Expiration: ⤷  Try a Trial

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering RUBRACA around the world.

Country Patent Number Title Estimated Expiration
Japan 2006519827 ⤷  Try a Trial
Japan 5466814 ⤷  Try a Trial
Poland 1684736 ⤷  Try a Trial
Lithuania 2534153 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for RUBRACA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1633724 596 Finland ⤷  Try a Trial
1633724 213 50005-2015 Slovakia ⤷  Try a Trial PRODUCT NAME: OLAPARIB; REGISTRATION NO/DATE: EU/1/14/959 20141218
1633724 C01633724/01 Switzerland ⤷  Try a Trial PRODUCT NAME: OLAPARIB; REGISTRATION NO/DATE: SWISSMEDIC 65160 14.01.2016
2534153 C201830056 Spain ⤷  Try a Trial PRODUCT NAME: CAMSILATO DE RUCAPARIB; NATIONAL AUTHORISATION NUMBER: EU/1/17/1250; DATE OF AUTHORISATION: 20180524; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/17/1250; DATE OF FIRST AUTHORISATION IN EEA: 20180524
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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.