You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: December 22, 2024

Details for New Drug Application (NDA): 209115


✉ Email this page to a colleague

« Back to Dashboard


NDA 209115 describes RUBRACA, which is a drug marketed by Pharmaand 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.
Summary for 209115
Tradename:RUBRACA
Applicant:Pharmaand
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
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: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:⤷  SubscribePatent Expiration:Aug 17, 2035Product 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:⤷  SubscribePatent Expiration:Aug 17, 2035Product 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 209115-001 Dec 19, 2016 ⤷  Subscribe ⤷  Subscribe
Pharmaand RUBRACA rucaparib camsylate TABLET;ORAL 209115-003 May 1, 2017 ⤷  Subscribe ⤷  Subscribe
Pharmaand RUBRACA rucaparib camsylate TABLET;ORAL 209115-002 Dec 19, 2016 ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.