RUCAPARIB CAMSYLATE - Generic Drug Details
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What are the generic drug sources for rucaparib camsylate and what is the scope of freedom to operate?
Rucaparib camsylate
is the generic ingredient in one branded drug marketed by Zr Pharma and is included in one NDA. There are eleven patents protecting this compound. Additional information is available in the individual branded drug profile pages.Rucaparib camsylate has two hundred and thirty-one patent family members in forty-two countries.
Two suppliers are listed for this compound.
Summary for RUCAPARIB CAMSYLATE
| International Patents: | 231 |
| US Patents: | 11 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 31 |
| Clinical Trials: | 6 |
| Patent Applications: | 9 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for RUCAPARIB CAMSYLATE |
| DailyMed Link: | RUCAPARIB CAMSYLATE at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for RUCAPARIB CAMSYLATE
Generic Entry Date for RUCAPARIB CAMSYLATE*:
Constraining patent/regulatory exclusivity:
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 RUCAPARIB CAMSYLATE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Alliance for Clinical Trials in Oncology | Phase 3 |
| National Cancer Institute (NCI) | Phase 3 |
| Clovis Oncology, Inc. | Phase 2 |
Pharmacology for RUCAPARIB CAMSYLATE
| Drug Class | Poly(ADP-Ribose) Polymerase Inhibitor |
| Mechanism of Action | Poly(ADP-Ribose) Polymerase Inhibitors |
US Patents and Regulatory Information for RUCAPARIB CAMSYLATE
| 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 | 209115-001 | Dec 19, 2016 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | 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 | ||||
| Zr Pharma | RUBRACA | rucaparib camsylate | TABLET;ORAL | 209115-001 | Dec 19, 2016 | 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 | ⤷ Try a Trial | ||||
| Zr Pharma | RUBRACA | rucaparib camsylate | TABLET;ORAL | 209115-001 | Dec 19, 2016 | 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 | ⤷ 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 RUCAPARIB CAMSYLATE
| 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 RUCAPARIB CAMSYLATE
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| World Intellectual Property Organization (WIPO) | 2004080976 | ⤷ Try a Trial | |
| Colombia | 5650256 | DERIVADOS DE FTALAZINONA | ⤷ Try a Trial |
| Denmark | 3150610 | ⤷ Try a Trial | |
| Mexico | 367260 | TABLETAS DE RUCAPARIB DE DOSIFICACIÓN ELEVADA. (HIGH DOSAGE STRENGTH TABLETS OF RUCAPARIB.) | ⤷ Try a Trial |
| Spain | 2545613 | ⤷ Try a Trial | |
| United Kingdom | 0520754 | ⤷ Try a Trial | |
| Japan | 7127101 | ⤷ Try a Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for RUCAPARIB CAMSYLATE
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1633724 | C 2015 011 | Romania | ⤷ Try a 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 | PA2018517 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: RUKAPARIBO KAMSILATAS; REGISTRATION NO/DATE: EU/1/17/1250 20180524 |
| 1633724 | 122015000025 | Germany | ⤷ Try a Trial | PRODUCT NAME: OLAPARIB, SOWIE SALZE UND SOLVATE DAVON; REGISTRATION NO/DATE: EU/1/14/959/001 20141216 |
| 1633724 | PA2015016 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: OLAPARIBUM; REGISTRATION NO/DATE: EU/1/14/959 20141216 |
| 1633724 | 92680 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: OLAPARIB AINSI QUE DES SELS ET DES SOLVATES DE CELUI-CI. FIRST REGISTRATION: 20141218 |
| 2534153 | 2018/043 | Ireland | ⤷ Try a Trial | PRODUCT NAME: RUCAPARIB CAMSYLATE; REGISTRATION NO/DATE: EU/1/17/1250 20180524 |
| 1633724 | S1500012 | Hungary | ⤷ Try a Trial | PRODUCT NAME: OLAPARIB |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
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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