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Generated: November 16, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 209115

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NDA 209115 describes RUBRACA, which is a drug marketed by Clovis Oncology Inc and is included in one NDA. It is available from one supplier. There are ten patents protecting this drug. Additional details are available on the RUBRACA profile page.

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.
Summary for 209115
Tradename:RUBRACA
Applicant:Clovis Oncology Inc
Ingredient:rucaparib camsylate
Patents:10
Generic Entry Opportunity Date for 209115
Generic Entry Date for 209115*:
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.

Pharmacology for NDA: 209115
Suppliers and Packaging for NDA: 209115
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RUBRACA rucaparib camsylate TABLET;ORAL 209115 NDA Clovis Oncology, Inc. 69660-201 69660-201-91 60 TABLET, FILM COATED in 1 BOTTLE (69660-201-91)
RUBRACA rucaparib camsylate TABLET;ORAL 209115 NDA Clovis Oncology, Inc. 69660-202 69660-202-91 60 TABLET, FILM COATED in 1 BOTTLE (69660-202-91)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 200MG BASE
Approval Date:Dec 19, 2016TE:RLD:Yes
Regulatory Exclusivity Expiration:Dec 19, 2023
Regulatory Exclusivity Use: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
Regulatory Exclusivity Expiration:Apr 6, 2021
Regulatory Exclusivity Use: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
Regulatory Exclusivity Expiration:Apr 6, 2025
Regulatory Exclusivity Use: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

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Julphar
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