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Generic Rubraca Availability

Rubraca is a brand name of rucaparib, approved by the FDA in the following formulation(s):

RUBRACA (rucaparib camsylate - tablet;oral)

  • Manufacturer: CLOVIS ONCOLOGY INC
    Approval date: December 19, 2016
    Strength(s): EQ 200MG BASE [RLD], EQ 300MG BASE [RLD]
  • Manufacturer: CLOVIS ONCOLOGY INC
    Approval date: May 1, 2017
    Strength(s): EQ 250MG BASE [RLD]

Has a generic version of Rubraca been approved?

No. There is currently no therapeutically equivalent version of Rubraca available in the United States.

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Rubraca. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.

See also: Generic Drug FAQs.

Related Patents

Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.

  • Tricyclic inhibitors of poly(ADP-ribose) polymerases
    Patent 6,495,541
    Issued: December 17, 2002
    Inventor(s): Stephen Evan; Webber & Stacie S.; Canan-Koch & Jayashree; Tikhe & Lars Henrik; Thoresen
    Assignee(s): Agouron Pharmaceuticals, Inc.

    Compounds of the formula below are poly(ADP-ribosyl)transferase (PARP) inhibitors, and are useful as therapuetics in treatment of cancers and the amelioration of the effects of stroke, head trauma, and nuerodegenerative disease. As cancer therapuetics, the compounds of the invention may be used, e.g., in combination with cytotoxic agents and/or radiation.

    Patent expiration dates:

    • January 10, 2020
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      Drug substance
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      Drug product
  • Therapeutic compounds
    Patent 7,351,701
    Issued: April 1, 2008
    Inventor(s): Helleday; Thomas & Curtin; Nicola
    Assignee(s): Cancer Research Technology Limited Pfizer, Inc.

    The invention relates to trycyclic lactam indole derivatives and triacyclic lactam benzimodole derivatives and their use in inhibiting the activity of PARP enzyme. The invention also relates to the use of these compounds in the preparation of medicaments.

    Patent expiration dates:

    • July 23, 2024
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      Patent use: MAINTENANCE TREATMENT OF RECURRENT EPITHELIAL OVARIAN, FALLOPIAN TUBE OR PRIMARY PERITONEAL CANCER, WHO ARE IN A COMPLETE OR PARTIAL RESPONSE TO PLATINUM-BASED CHEMOTHERAPY
    • July 23, 2024
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      Patent use: A METHOD FOR TREATING OVARIAN CANCER BY ADMINISTERING RUCAPARIB, WHEREIN THE CANCER IS ASSOCIATED WITH A DELETERIOUS BRCA MUTATION
    • July 23, 2024
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      Patent use: A METHOD FOR TREATING EPITHELIAL OVARIAN, FALLOPIAN TUBE, OR PRIMARY PERITONEAL CANCER, WHEREIN THE CANCER IS ASSOCIATED WITH A DELETERIOUS BRCA MUTATION
  • Therapeutic compounds
    Patent 7,531,530
    Issued: May 12, 2009
    Inventor(s): Helleday; Thomas & Curtin; Nicola
    Assignee(s): Cancer Research Technology Limited Pfizer

    The invention relates to trycyclic lactam indole derivatives and triacyclic lactam benzimodole derivatives and their use in inhibiting the activity of PARP enzyme. The invention also relates to the use of these compounds in the preparation of medicaments.

    Patent expiration dates:

    • July 23, 2024
      ✓ 
      Patent use: MAINTENANCE TREATMENT OF RECURRENT EPITHELIAL OVARIAN, FALLOPIAN TUBE OR PRIMARY PERITONEAL CANCER, WHO ARE IN A COMPLETE OR PARTIAL RESPONSE TO PLATINUM-BASED CHEMOTHERAPY
    • July 23, 2024
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      Patent use: A METHOD FOR TREATING EPITHELIAL OVARIAN, FALLOPIAN TUBE, OR PRIMARY PERITONEAL CANCER, WHEREIN THE CANCER IS ASSOCIATED WITH A DELETERIOUS BRCA MUTATION
    • July 23, 2024
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      Patent use: A METHOD FOR TREATING OVARIAN CANCER BY ADMINISTERING RUCAPARIB, WHEREIN THE CANCER IS ASSOCIATED WITH A DELETERIOUS BRCA MUTATION
  • DNA damage repair inhibitors for the treatment of cancer
    Patent 8,071,579
    Issued: December 6, 2011
    Inventor(s): Ashworth; Alan & Jackson; Stephen & Martin; Niall & Smith; Graeme
    Assignee(s): The Institute of Cancer Research: Royal Cancer Hospital Kudos Pharmaceuticals Limited

    The present invention relates to the recognition that inhibition of the base excision repair pathway is selectively lethal in cells which are deficient in HR dependent DNA DSB repair. Methods and means relating to the treatment of cancers which are deficient in HR dependent DNA DSB repair using inhibitors which target base excision repair components, such as PARP, is provided herein.

    Patent expiration dates:

    • August 12, 2027
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      Patent use: MAINTENANCE TREATMENT OF RECURRENT EPITHELIAL OVARIAN, FALLOPIAN TUBE OR PRIMARY PERITONEAL CANCER, WHO ARE IN A COMPLETE OR PARTIAL RESPONSE TO PLATINUM-BASED CHEMOTHERAPY
    • August 12, 2027
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      Patent use: A METHOD FOR TREATING OVARIAN CANCER BY ADMINISTERING RUCAPARIB, WHEREIN THE CANCER IS ASSOCIATED WITH A DELETERIOUS BRCA MUTATION
    • August 12, 2027
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      Patent use: A METHOD FOR TREATING EPITHELIAL OVARIAN, FALLOPIAN TUBE, OR PRIMARY PERITONEAL CANCER, WHEREIN THE CANCER IS ASSOCIATED WITH A DELETERIOUS BRCA MUTATION
  • DNA damage repair inhibitors for treatment of cancer
    Patent 8,143,241
    Issued: March 27, 2012
    Inventor(s): Ashworth; Alan & Jackson; Stephen & Martin; Niall & Smith; Graeme & O'Connor; Mark
    Assignee(s): Kudos Pharmaceuticals Limited The Institute of Cancer Research

    The present invention relates to the recognition that inhibition of the base excision repair pathway is selectively lethal in cells which are deficient in HR dependent DNA DSB repair. Methods and means relating to the treatment of cancers which are deficient in HR dependent DNA DSB repair using inhibitors which target base excision repair components, such as PARP, is provided herein.

    Patent expiration dates:

    • August 12, 2027
      ✓ 
      Patent use: MAINTENANCE TREATMENT OF RECURRENT EPITHELIAL OVARIAN, FALLOPIAN TUBE OR PRIMARY PERITONEAL CANCER, WHO ARE IN A COMPLETE OR PARTIAL RESPONSE TO PLATINUM-BASED CHEMOTHERAPY
    • August 12, 2027
      ✓ 
      Patent use: A METHOD FOR TREATING EPITHELIAL OVARIAN, FALLOPIAN TUBE, OR PRIMARY PERITONEAL CANCER, WHEREIN THE CANCER IS ASSOCIATED WITH A DELETERIOUS BRCA MUTATION
    • August 12, 2027
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      Patent use: A METHOD FOR TREATING OVARIAN CANCER BY ADMINISTERING RUCAPARIB, WHEREIN THE CANCER IS ASSOCIATED WITH A DELETERIOUS BRCA MUTATION
  • Salts and polymorphs of 8-fluoro-2-{4-[(methylamino)methyl]phenyl}-1,3,4,5-tetrahydro-6h-azepino[5,4,3-cd]indol-6-one
    Patent 8,754,072
    Issued: June 17, 2014
    Assignee(s): Pfizer Inc.

    The present invention relates to novel polymorphic forms of 8-fluoro-2-{4-[(methylamino)methyl]phenyl}-1,3,4,5-tetrahydro-6H-azepino[5,4,3-cd]indol-6-one, and to processes for their preparation. Such polymorphic forms may be a component of a pharmaceutical composition and may be used to treat a mammalian disease condition mediated by poly(ADP-ribose) polymerase activity including the disease condition such as cancer.

    Patent expiration dates:

    • February 10, 2031
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      Drug substance
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      Drug product
  • Use of RNAI inhibiting PARP activity for the manufacture of a medicament for the treatment of cancer
    Patent 8,859,562
    Issued: October 14, 2014
    Assignee(s): The University of Sheffield

    The present invention relates to the use of an agent that inhibits the activity of an enzyme that mediates repair of a DNA strand break in the manufacture of a medicament for the treatment of diseases caused by a defect in a gene that mediates homologous recombination.

    Patent expiration dates:

    • August 4, 2031
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      Patent use: MAINTENANCE TREATMENT OF RECURRENT EPITHELIAL OVARIAN, FALLOPIAN TUBE OR PRIMARY PERITONEAL CANCER, WHO ARE IN A COMPLETE OR PARTIAL RESPONSE TO PLATINUM-BASED CHEMOTHERAPY
    • August 4, 2031
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      Patent use: A METHOD FOR TREATING EPITHELIAL OVARIAN, FALLOPIAN TUBE, OR PRIMARY PERITONEAL CANCER, WHEREIN THE CANCER IS ASSOCIATED WITH A DELETERIOUS BRCA MUTATION
    • August 4, 2031
      ✓ 
      Patent use: A METHOD FOR TREATING OVARIAN CANCER BY ADMINISTERING RUCAPARIB, WHEREIN THE CANCER IS ASSOCIATED WITH A DELETERIOUS BRCA MUTATION
  • Salts and polymorphs of 8-fluoro-2-{4-[(methylamino)methyl]phenyl}-1,3,4,5-tetrahydro-6H-azepino[5,4,3-cd]indol-6-one
    Patent 9,045,487
    Issued: June 2, 2015
    Assignee(s): PFIZER INC.

    The present invention relates to novel polymorphic forms of 8-fluoro-2-{4-[(methylamino)methyl]phenyl}-1,3,4,5-tetrahydro-6H-azepino[5,4,3-cd]indol-6-one, and to processes for their preparation. Such polymorphic forms may be a component of a pharmaceutical composition and may be used to treat a mammalian disease condition mediated by poly(ADP-ribose) polymerase activity including the disease condition such as cancer.

    Patent expiration dates:

    • February 10, 2031
      ✓ 
      Drug substance
      ✓ 
      Drug product
  • Salts and polymorphs of 8-fluoro-2-{4-[(methylamino)methyl]phenyl}-1,3,4,5-tetrahydro-6H-azepino[5,4,3-cd]indol-6-one
    Patent 9,861,638
    Issued: January 9, 2018
    Assignee(s): PFIZER INC.

    The present invention relates to novel polymorphic forms of 8-fluoro-2-{4-[(methylamino)methyl]phenyl}-1,3,4,5-tetrahydro-6H-azepino[5,4,3-cd]indol-6-one, and to processes for their preparation. Such polymorphic forms may be a component of a pharmaceutical composition and may be used to treat a mammalian disease condition mediated by poly(ADP-ribose) polymerase activity including the disease condition such as cancer.

    Patent expiration dates:

    • February 10, 2031
      ✓ 
      Patent use: MAINTENANCE TREATMENT OF RECURRENT EPITHELIAL OVARIAN, FALLOPIAN TUBE OR PRIMARY PERITONEAL CANCER, WHO ARE IN A COMPLETE OR PARTIAL RESPONSE TO PLATINUM-BASED CHEMOTHERAPY
    • February 10, 2031
      ✓ 
      Patent use: A METHOD FOR TREATING EPITHELIAL OVARIAN, FALLOPIAN TUBE, OR PRIMARY PERITONEAL CANCER, WHEREIN THE CANCER IS ASSOCIATED WITH A DELETERIOUS BRCA MUTATION
    • February 10, 2031
      ✓ 
      Patent use: A METHOD FOR TREATING OVARIAN CANCER BY ADMINISTERING RUCAPARIB, WHEREIN THE CANCER IS ASSOCIATED WITH A DELETERIOUS BRCA MUTATION
  • High dosage strength tablets of rucaparib
    Patent 9,987,285
    Issued: June 5, 2018
    Assignee(s): CLOVIS ONCOLOGY, INC.

    A tablet including high dosage of 8-fluoro-2-{4-[(methylamino)methyl]phenyl}-1,3,4,5-tetrahydro-6H-azepino[5,4,3-cd]indol-6-one camsylate salt has been disclosed.

    Patent expiration dates:

    • August 17, 2035
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      Drug product

Related Exclusivities

Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.

  • Exclusivity expiration dates:

    • April 6, 2021 - 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
    • December 19, 2021 - NEW CHEMICAL ENTITY
    • December 19, 2023 -
    • April 6, 2025 -
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Glossary
TermDefinition
Drug PatentA drug patent is assigned by the U.S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation.
Drug ExclusivityExclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant.
RLDA Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart.

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