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Details for New Drug Application (NDA): 209115
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 eleven 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.
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: | 11 |
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, 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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