Details for New Drug Application (NDA): 209115
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NDA 209115 describes RUBRACA, which is a drug marketed by Pharmaand and is included in one NDA. It is available from one supplier. There are nine patents protecting this drug. Additional details are available on the RUBRACA profile page.
The generic ingredient in RUBRACA is rucaparib camsylate. There is one drug master file entry for this compound. 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. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the rucaparib camsylate profile page.
Summary for 209115
| Tradename: | RUBRACA |
| Applicant: | Pharmaand |
| Ingredient: | rucaparib camsylate |
| Patents: | 9 |
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 | pharmaand GmbH | 82154-0783 | 82154-0783-1 | 60 TABLET, FILM COATED in 1 BOTTLE (82154-0783-1) |
| RUBRACA | rucaparib camsylate | TABLET;ORAL | 209115 | NDA | pharmaand GmbH | 82154-0784 | 82154-0784-1 | 60 TABLET, FILM COATED in 1 BOTTLE (82154-0784-1) |
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 17, 2028 | ||||||||
| Regulatory Exclusivity Use: | EXPANSION TO THE TREATMENT OF ADULT PATIENTS WITH A DELETERIOUS BRCA MUTATION (GERMLINE AND/OR SOMATIC)-ASSOCIATED METASTATIC CASTRATION-RESISTANT PROSTATE CANCER (MCRPC) INDICATION | ||||||||
| Patent: | 10,130,636 | 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: | 10,130,636 | 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 |
|---|---|---|---|---|---|---|---|
| Pharmaand | RUBRACA | rucaparib camsylate | TABLET;ORAL | 209115-003 | May 1, 2017 | 7,351,701 | ⤷ Start Trial |
| Pharmaand | RUBRACA | rucaparib camsylate | TABLET;ORAL | 209115-003 | May 1, 2017 | 6,495,541 | ⤷ Start Trial |
| Pharmaand | RUBRACA | rucaparib camsylate | TABLET;ORAL | 209115-001 | Dec 19, 2016 | 6,495,541 | ⤷ Start Trial |
| Pharmaand | RUBRACA | rucaparib camsylate | TABLET;ORAL | 209115-002 | Dec 19, 2016 | 6,495,541 | ⤷ Start Trial |
| Pharmaand | RUBRACA | rucaparib camsylate | TABLET;ORAL | 209115-002 | Dec 19, 2016 | 7,351,701 | ⤷ Start Trial |
| Pharmaand | RUBRACA | rucaparib camsylate | TABLET;ORAL | 209115-001 | Dec 19, 2016 | 7,531,530 | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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