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Last Updated: May 26, 2022

RUBRACA Drug Patent Profile


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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.

Indicators of Generic Entry

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Summary for RUBRACA
International Patents:278
US Patents:12
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 64
Clinical Trials: 21
Patent Applications: 85
Drug Prices: Drug price information for RUBRACA
What excipients (inactive ingredients) are in RUBRACA?RUBRACA excipients list
DailyMed Link:RUBRACA at DailyMed
Drug patent expirations by year for RUBRACA
Drug Prices for RUBRACA

See drug prices for RUBRACA

DrugPatentWatch® Estimated 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
BayerPhase 1/Phase 2
The Miriam HospitalPhase 1/Phase 2
Rhode Island HospitalPhase 1/Phase 2

See all RUBRACA clinical trials

US Patents and Regulatory Information for RUBRACA

RUBRACA is protected by twenty-six US patents and three FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of RUBRACA is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Tricyclic inhibitors of poly(ADP-ribose) polymerases
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Therapeutic compounds
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Use of RNAI inhibiting PARP activity for the manufacture of a medicament for the treatment of cancer
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

FDA Regulatory Exclusivity protecting RUBRACA

AS MONOTHERAPY FOR THE TREATMENT OF PATIENTS WITH DELETERIOUS BRCA MUTATION (GERMLINE AND/OR SOMATIC) ASSOCIATED ADVANCED OVARIAN CANCER WHO HAVE BEEN TREATED WITH TWO OR MORE CHEMOTHERAPIES
Exclusivity Expiration: See Plans and Pricing

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: See Plans and Pricing

TREATMENT OF ADULT PATIENTS WITH A DELETERIOUS BRCA MUTATION (GERMLINE AND/OR SOMATIC)-ASSOCIATED METASTATIC CASTRATION-RESISTANT PROSTATE CANCER WHO HAVE BEEN TREATED WITH ANDROGEN RECEPTOR-DIRECTED THERAPY AND A TAXANE-BASED CHEMOTHERAPY
Exclusivity Expiration: See Plans and Pricing

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 Plans and Pricing See Plans and Pricing See Plans and Pricing
Clovis Oncology Inc RUBRACA rucaparib camsylate TABLET;ORAL 209115-002 Dec 19, 2016 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Clovis Oncology Inc RUBRACA rucaparib camsylate TABLET;ORAL 209115-003 May 1, 2017 RX Yes No See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
>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

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: See Plans and Pricing

Patent: 19272064
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 2017000865
Estimated Expiration: See Plans and Pricing

Canada

Patent: 55495
Estimated Expiration: See Plans and Pricing

China

Patent: 6794185
Estimated Expiration: See Plans and Pricing

Patent: 3209033
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 82975
Estimated Expiration: See Plans and Pricing

Israel

Patent: 9946
Estimated Expiration: See Plans and Pricing

Japan

Patent: 74477
Estimated Expiration: See Plans and Pricing

Patent: 97980
Estimated Expiration: See Plans and Pricing

Patent: 17525712
Estimated Expiration: See Plans and Pricing

Patent: 20002149
Estimated Expiration: See Plans and Pricing

Patent: 21038242
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 7260
Estimated Expiration: See Plans and Pricing

Patent: 17001540
Estimated Expiration: See Plans and Pricing

Russian Federation

Patent: 05156
Estimated Expiration: See Plans and Pricing

Patent: 17109139
Estimated Expiration: See Plans and Pricing

Singapore

Patent: 201700265V
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 170043597
Estimated Expiration: See Plans and Pricing

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
Poland 1633724 See Plans and Pricing
South Africa 200600679 THERAPEUTIC COMPOUNDS See Plans and Pricing
Argentina 109356 SALES Y POLIMORFOS DE 8-FLUORO-2-{4-[(METILAMINO)METIL]FENIL}-1,3,4,5-TETRAHIDRO-6H-ACEPINO[5,4,3-CD]INDOL-6-ONA See Plans and Pricing
>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 See Plans and Pricing
2534153 PA2018517 Lithuania See Plans and Pricing PRODUCT NAME: RUKAPARIBO KAMSILATAS; REGISTRATION NO/DATE: EU/1/17/1250 20180524
2534153 1890042-3 Sweden See Plans and Pricing PRODUCT NAME: RUCAPARIB CAMSYLATE; REG. NO/DATE: EU/1/17/1250 20180529
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Medtronic
McKesson
Baxter
Moodys
Johnson and Johnson
AstraZeneca

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.