RUBRACA Drug Patent Profile
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Which patents cover Rubraca, and what generic alternatives are available?
Rubraca is a drug marketed by Pharmaand and is included in one NDA. There are eleven patents protecting this drug.
This drug has two hundred and thirty-four patent family members in forty-three 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 have been four patent litigation cases 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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Summary for RUBRACA
| International Patents: | 234 |
| US Patents: | 11 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 70 |
| Clinical Trials: | 21 |
| Drug Prices: | Drug price information for RUBRACA |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for RUBRACA |
| What excipients (inactive ingredients) are in RUBRACA? | RUBRACA excipients list |
| DailyMed Link: | RUBRACA at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for RUBRACA
*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
| Sponsor | Phase |
|---|---|
| Brown University | Phase 1/Phase 2 |
| Bayer | Phase 1/Phase 2 |
| The Miriam Hospital | Phase 1/Phase 2 |
Pharmacology for RUBRACA
| Drug Class | Poly(ADP-Ribose) Polymerase Inhibitor |
| Mechanism of Action | Poly(ADP-Ribose) Polymerase Inhibitors |
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 ⤷ Sign Up.
This potential generic entry date is based on patent ⤷ Sign Up.
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Therapeutic compounds
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Use of RNAI inhibiting PARP activity for the manufacture of a medicament for the treatment of cancer
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Pharmaand | RUBRACA | rucaparib camsylate | TABLET;ORAL | 209115-003 | May 1, 2017 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Pharmaand | RUBRACA | rucaparib camsylate | TABLET;ORAL | 209115-003 | May 1, 2017 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Pharmaand | RUBRACA | rucaparib camsylate | TABLET;ORAL | 209115-003 | May 1, 2017 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Pharmaand | RUBRACA | rucaparib camsylate | TABLET;ORAL | 209115-002 | Dec 19, 2016 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Pharmaand | RUBRACA | rucaparib camsylate | TABLET;ORAL | 209115-003 | May 1, 2017 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Pharmaand | RUBRACA | rucaparib camsylate | TABLET;ORAL | 209115-003 | May 1, 2017 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Pharmaand | RUBRACA | rucaparib camsylate | TABLET;ORAL | 209115-001 | Dec 19, 2016 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| >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 |
|---|---|---|---|---|---|---|---|
| Pharmaand | RUBRACA | rucaparib camsylate | TABLET;ORAL | 209115-002 | Dec 19, 2016 | ⤷ Sign Up | ⤷ Sign Up |
| Pharmaand | RUBRACA | rucaparib camsylate | TABLET;ORAL | 209115-002 | Dec 19, 2016 | ⤷ Sign Up | ⤷ Sign Up |
| Pharmaand | RUBRACA | rucaparib camsylate | TABLET;ORAL | 209115-002 | Dec 19, 2016 | ⤷ Sign Up | ⤷ Sign Up |
| Pharmaand | RUBRACA | rucaparib camsylate | TABLET;ORAL | 209115-001 | Dec 19, 2016 | ⤷ Sign Up | ⤷ Sign Up |
| Pharmaand | RUBRACA | rucaparib camsylate | TABLET;ORAL | 209115-003 | May 1, 2017 | ⤷ Sign Up | ⤷ Sign Up |
| Pharmaand | RUBRACA | rucaparib camsylate | TABLET;ORAL | 209115-003 | May 1, 2017 | ⤷ Sign Up | ⤷ Sign Up |
| Pharmaand | RUBRACA | rucaparib camsylate | TABLET;ORAL | 209115-001 | Dec 19, 2016 | ⤷ Sign Up | ⤷ Sign Up |
| >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
Patent: High dosage strength tablets of rucaparib
Estimated Expiration: ⤷ Sign Up
Patent: 19272064
Patent: High dosage strength tablets of rucaparib
Estimated Expiration: ⤷ Sign Up
Brazil
Patent: 2017000865
Patent: comprimidos de rucaparibe de concentração de dosagem alta
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 55495
Patent: COMPRIMES DE RUCAPARIB A DOSAGE ELEVE (HIGH DOSAGE STRENGTH TABLETS OF RUCAPARIB)
Estimated Expiration: ⤷ Sign Up
China
Patent: 6794185
Patent: Rucaparib的高剂量强度片剂 (High dosage strength tablets of rucaparib)
Estimated Expiration: ⤷ Sign Up
Patent: 3209033
Patent: Rucaparib的高剂量强度片剂 (High dosage strength tablets of rucaparib)
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 82975
Patent: COMPRIMÉS DE RUCAPARIB À DOSAGE ÉLEVÉ (HIGH DOSAGE STRENGTH TABLETS OF RUCAPARIB)
Estimated Expiration: ⤷ Sign Up
Israel
Patent: 9946
Patent: טבליות רוקפריב בחוזק מינון גבוה (High dosage strength tablets of rucaparib)
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 74477
Estimated Expiration: ⤷ Sign Up
Patent: 97980
Estimated Expiration: ⤷ Sign Up
Patent: 27101
Estimated Expiration: ⤷ Sign Up
Patent: 17525712
Patent: ルカパリブの高投与力価錠剤
Estimated Expiration: ⤷ Sign Up
Patent: 20002149
Patent: ルカパリブの高投与力価錠剤 (HIGH DOSAGE STRENGTH TABLETS OF RUCAPARIB)
Estimated Expiration: ⤷ Sign Up
Patent: 21038242
Patent: ルカパリブの高投与力価錠剤 (HIGH DOSAGE STRENGTH TABLETS OF RUCAPARIB)
Estimated Expiration: ⤷ Sign Up
Mexico
Patent: 7260
Patent: TABLETAS DE RUCAPARIB DE DOSIFICACIÓN ELEVADA. (HIGH DOSAGE STRENGTH TABLETS OF RUCAPARIB.)
Estimated Expiration: ⤷ Sign Up
Patent: 17001540
Patent: TABLETAS DE RUCAPARIB DE DOSIFICACION ELEVADA. (HIGH DOSAGE STRENGTH TABLETS OF RUCAPARIB.)
Estimated Expiration: ⤷ Sign Up
New Zealand
Patent: 8392
Patent: High dosage strength tablets of rucaparib
Estimated Expiration: ⤷ Sign Up
Russian Federation
Patent: 05156
Patent: ТАБЛЕТКИ, СОДЕРЖАЩИЕ БОЛЬШУЮ ДОЗУ РУКАПАРИБА (HIGH DOSAGE STRENGTH TABLETS OF RUCAPARIB)
Estimated Expiration: ⤷ Sign Up
Patent: 17109139
Patent: ТАБЛЕТКИ, СОДЕРЖАЩИЕ БОЛЬШУЮ ДОЗУ РУКАПАРИБА
Estimated Expiration: ⤷ Sign Up
Singapore
Patent: 201700265V
Patent: HIGH DOSAGE STRENGTH TABLETS OF RUCAPARIB
Estimated Expiration: ⤷ Sign Up
South Korea
Patent: 170043597
Patent: 루카파립의 고 용량 강도 정제 (High Dosage Strength Tablets of Rucaparib)
Estimated Expiration: ⤷ Sign Up
Patent: 230097211
Patent: 루카파립의 고 용량 강도 정제 (High Dosage Strength Tablets of Rucaparib)
Estimated Expiration: ⤷ Sign Up
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 |
|---|---|---|---|
| World Intellectual Property Organization (WIPO) | 2005012524 | ⤷ Sign Up | |
| New Zealand | 545307 | Use of RNAI inhibiting parp activity for the manufacture of a medicament for the treatment of cancer | ⤷ Sign Up |
| Cyprus | 2018031 | ⤷ Sign Up | |
| Austria | 261963 | ⤷ Sign Up | |
| Finland | 2534153 | ⤷ Sign Up | |
| China | 1856572 | Use of RNAi inhibiting parp activtiy for the manufacture of a medicament for the treatment of cancer | ⤷ Sign Up |
| China | 100418967 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for RUBRACA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1633724 | 122015000025 | Germany | ⤷ Sign Up | PRODUCT NAME: OLAPARIB, SOWIE SALZE UND SOLVATE DAVON; REGISTRATION NO/DATE: EU/1/14/959/001 20141216 |
| 1633724 | 1590019-4 | Sweden | ⤷ Sign Up | PRODUCT NAME: OLAPARIB, AND SALTS AND SOLVATES THEREOF; REG. NO/DATE: EU/1/14/959 20141218 |
| 2534153 | 2018039 | Norway | ⤷ Sign Up | PRODUCT NAME: RUKAPARIBKAMSYLAT; REG. NO/DATE: EU/1/17/1250 20180531 |
| 2534153 | 122018000131 | Germany | ⤷ Sign Up | PRODUCT NAME: RUCAPARIB CAMSYLAT; REGISTRATION NO/DATE: EU/1/17/1250 20180524 |
| 1633724 | C20150012 00136 | Estonia | ⤷ Sign Up | PRODUCT NAME: OLAPARIIB;REG NO/DATE: EU/1/14/959 18.12.2014 |
| 2534153 | 18C1049 | France | ⤷ Sign Up | PRODUCT NAME: CAMSYLATE DE RUCAPARIB; NAT. REGISTRATION NO/DATE: EU/1/17/1250 20180529; FIRST REGISTRATION: - EU/1/17/1250 20180529 |
| 1633724 | C 2015 011 | Romania | ⤷ Sign Up | 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 |
| >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.
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