Details for New Drug Application (NDA): 209115
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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: | 12 |
DrugPatentWatch® Estimated 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
Mechanism of Action | Poly(ADP-Ribose) Polymerase Inhibitors |
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: | RX | Dosage: | TABLET;ORAL | Strength | EQ 200MG BASE | ||||
Approval Date: | Dec 19, 2016 | TE: | 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, 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 | ||||||||
Regulatory Exclusivity Expiration: | May 15, 2023 | ||||||||
Regulatory Exclusivity Use: | 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 |
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