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RUBRACA Drug 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 seventy-two patent family members in fifty-three 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.
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
Summary for RUBRACA
| International Patents: | 272 |
| US Patents: | 12 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 56 |
| Clinical Trials: | 15 |
| Patent Applications: | 773 |
| Drug Prices: | Drug price information for RUBRACA |
| DailyMed Link: | RUBRACA at DailyMed |
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
| Sponsor | Phase |
|---|---|
| Rhode Island Hospital | Phase 1/Phase 2 |
| The Miriam Hospital | 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 |
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 | ||
| Clovis Oncology Inc | RUBRACA | rucaparib camsylate | TABLET;ORAL | 209115-002 | Dec 19, 2016 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Clovis Oncology Inc | RUBRACA | rucaparib camsylate | TABLET;ORAL | 209115-003 | May 1, 2017 | RX | Yes | No | Start Trial | Start Trial | 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 |
International Patents for RUBRACA
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Portugal | 3150610 | Start Trial |
| Japan | 6013551 | Start Trial |
| Argentina | 080164 | Start Trial |
| Norway | 2015008 | Start Trial |
| Cyprus | 1118319 | Start Trial |
| European Patent Office | 1633724 | Start Trial |
| >Country | >Patent Number | >Estimated 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 |
| 1633724 | CR 2015 00012 | Denmark | Start Trial | PRODUCT NAME: OLAPARIB, OG SALTE OG SOLVATER DERAF; REG. NO/DATE: EU/1/14/959/001 20141216 |
| 1633724 | 15C0022 | France | Start Trial | PRODUCT NAME: OLAPARIB,SELS ET SOLVATES DE CELUI-CI; REGISTRATION NO/DATE: EU 1/14/959 20141218 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
