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 Clovis Oncology Inc and is included in one NDA. There are twelve patents protecting this drug.
This drug has two hundred and eighty-one patent family members in fifty-four countries.
The generic ingredient in RUBRACA is rucaparib camsylate. One supplier is 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
Summary for RUBRACA
| International Patents: | 281 |
| US Patents: | 12 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 69 |
| Clinical Trials: | 21 |
| Patent Applications: | 1,592 |
| 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
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
| Sponsor | Phase |
|---|---|
| Rhode Island Hospital | Phase 1/Phase 2 |
| Brown University | Phase 1/Phase 2 |
| Bayer | Phase 1/Phase 2 |
Pharmacology for RUBRACA
| Drug Class | Poly(ADP-Ribose) Polymerase Inhibitor |
| Mechanism of Action | Poly(ADP-Ribose) Polymerase Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for RUBRACA
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 ⤷ 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
Tricyclic inhibitors of poly(ADP-ribose) polymerases
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
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: ⤷ Try a Trial
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
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: ⤷ 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Clovis Oncology Inc | RUBRACA | rucaparib camsylate | TABLET;ORAL | 209115-002 | Dec 19, 2016 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Clovis Oncology Inc | RUBRACA | rucaparib camsylate | TABLET;ORAL | 209115-002 | Dec 19, 2016 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Clovis Oncology Inc | RUBRACA | rucaparib camsylate | TABLET;ORAL | 209115-003 | May 1, 2017 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
| Clovis Oncology Inc | 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 |
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: 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
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
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 | ⤷ Try a Trial | |
| Indonesia | 30138 | ⤷ Try a Trial | |
| Japan | 6797980 | ⤷ Try a Trial | |
| World Intellectual Property Organization (WIPO) | 2005012305 | ⤷ 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 |
|---|---|---|---|---|
| 2534153 | CA 2018 00041 | Denmark | ⤷ Try a Trial | PRODUCT NAME: RUCAPARIB CAMSYLATE; REG. NO/DATE: EU/1/17/1250/001-003 20180529 |
| 1633724 | S1500012 | Hungary | ⤷ Try a Trial | PRODUCT NAME: OLAPARIB |
| 1633724 | C20150012 00136 | Estonia | ⤷ Try a Trial | PRODUCT NAME: OLAPARIIB;REG NO/DATE: EU/1/14/959 18.12.2014 |
| 2534153 | C20180033 00273 | Estonia | ⤷ Try a Trial | PRODUCT NAME: RUKAPARIIB;REG NO/DATE: EU/1/17/1250 29.05.2018 |
| >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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