Details for New Drug Application (NDA): 209115
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NDA 209115 describes RUBRACA, which is a drug marketed by Zr Pharma and is included in one NDA. It is available from two suppliers. There are eleven patents protecting this drug. Additional details are available on the RUBRACA profile page.
The generic ingredient in RUBRACA is rucaparib camsylate. Two suppliers are listed for this compound. Additional details are available on the rucaparib camsylate profile page.
The generic ingredient in RUBRACA is rucaparib camsylate. Two suppliers are listed for this compound. Additional details are available on the rucaparib camsylate profile page.
Summary for 209115
| Tradename: | RUBRACA |
| Applicant: | Zr Pharma |
| Ingredient: | rucaparib camsylate |
| Patents: | 11 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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: | 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 | ||||||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Aug 17, 2035 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | A METHOD FOR TREATING EPITHELIAL OVARIAN, FALLOPIAN TUBE, OR PRIMARY PERITONEAL CANCER, WHEREIN THE CANCER IS ASSOCIATED WITH A DELETERIOUS BRCA MUTATION | ||||||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Aug 17, 2035 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | A METHOD FOR TREATING METASTATIC CASTRATION-RESISTANT PROSTATE CANCER (MCRPC), WHEREIN THE CANCER IS ASSOCIATED WITH A DELETERIOUS BRCA-MUTATION | ||||||||
Expired US Patents for NDA 209115
| 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 |
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