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Generic Cabometyx Availability

Last updated on Oct 6, 2021.

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

CABOMETYX (cabozantinib s-malate - tablet;oral)

  • Manufacturer: EXELIXIS INC
    Approval date: April 25, 2016
    Strength(s): EQ 20MG BASE [RLD], EQ 40MG BASE [RLD], EQ 60MG BASE [RLD]

Has a generic version of Cabometyx been approved?

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

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Cabometyx. 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 FAQ.

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.

  • C-met modulator pharmaceutical compositions
    Patent 10,034,873
    Issued: July 31, 2018
    Assignee(s): Exelixis, Inc.

    Pharmaceutical compositions and unit dosage forms comprising Compound I are disclosed.

    Patent expiration dates:

    • July 18, 2031
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      Patent use: TREATMENT OF PATIENTS WITH HEPATOCELLULAR CARCINOMA (HCC) WHO HAVE BEEN PREVIOUSLY TREATED WITH SORAFENIB
  • C-Met modulator pharmaceutical compositions
    Patent 10,039,757
    Issued: August 7, 2018
    Assignee(s): Exelixis, Inc.

    Pharmaceutical compositions and unit dosage forms comprising Compound I are disclosed.

    Patent expiration dates:

    • July 18, 2031
      ✓ 
      Patent use: TREATMENT OF ADVANCED RENAL CELL CARCINOMA
  • Patent 11,091,439

    Patent expiration dates:

    • January 15, 2030
      ✓ 
      Drug substance
  • Patent 11,091,440

    Patent expiration dates:

    • January 15, 2030
      ✓ 
      Drug product
  • Patent 11,098,015

    Patent expiration dates:

    • January 15, 2030
      ✓ 
      Patent use: TREATMENT OF PATIENTS WITH HEPATOCELLULAR CARCINOMA (HCC) WHO HAVE BEEN PREVIOUSLY TREATED WITH SORAFENIB
    • January 15, 2030
      ✓ 
      Patent use: TREATMENT OF RENAL CELL CARCINOMA
    • January 15, 2030
      ✓ 
      Patent use: TREATMENT OF ADVANCED RENAL CELL CARCINOMA
  • c-Met modulators and methods of use
    Patent 7,579,473
    Issued: August 25, 2009
    Inventor(s): Bannen; Lynne Canne & Chan; Diva Sze-Ming & Forsyth; Timothy Patrick & Khoury; Richard George & Leahy; James William & Mac; Morrisson B. & Mann; Larry W. & Nuss; John M. & Parks; Jason Jevious & Wang; Yong & Xu; Wie
    Assignee(s): Exelixis, Inc.

    The present invention provides compounds for modulating protein kinase enzymatic activity for modulating cellular activities such as proliferation, differentiation, programmed cell death, migration and chemoinvasion. More specifically, the invention provides quinazolines and quinolines which inhibit, regulate, and/or modulate kinase receptor, particularly c-Met, KDF, c-Kit, flt-3 and flt-4, signal transduction pathways related to the changes in cellular activities as mentioned above, compositions which contain these compounds, and methods of using them to treat kinase-dependent diseases and conditions. The present invention also provides methods for making compounds as mentioned above, and compositions which contain these compounds.

    Patent expiration dates:

    • August 14, 2026
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      Drug substance
      ✓ 
      Drug product
  • C-met modulators and method of use
    Patent 8,497,284
    Issued: July 30, 2013
    Assignee(s): Exelixis, Inc.

    The present invention provides compounds for modulating protein kinase enzymatic activity for modulating cellular activities such as proliferation, differentiation, programmed cell death, migration and chemoinvasion. More specifically, the invention provides quinazolines and quinolines which inhibit, regulate, and/or modulate kinase receptor, particularly c-Met, KDF, c-Kit, flt-3 and flt-4, signal transduction pathways related to the changes in cellular activities as mentioned above, compositions which contain these compounds, and methods of using them to treat kinase-dependent diseases and conditions. The present invention also provides methods for making compounds as mentioned above, and compositions which contain these compounds.

    Patent expiration dates:

    • September 24, 2024
      ✓ 
      Patent use: TREATMENT OF RENAL CELL CARCINOMA
    • September 24, 2024
      ✓ 
      Patent use: TREATMENT OF PATIENTS WITH HEPATOCELLULAR CARCINOMA (HCC) WHO HAVE BEEN PREVIOUSLY TREATED WITH SORAFENIB
    • September 24, 2024
      ✓ 
      Patent use: TREATMENT OF ADVANCED RENAL CELL CARCINOMA
  • (L)-malate salt of N-(4-{[6,7-bis(methyloxy) quinolin-4-yl]oxy}phenyl)-N'-(4-fluorophenyl)cyclopropane-1,1-dicarboxamide
    Patent 8,877,776
    Issued: November 4, 2014
    Assignee(s): Exelixis, Inc.

    Disclosed are malate salts of N-(4-{[6,7-bis(methyloxy)-quinolin-4-yl]oxy}phenyl)-N′-(4-fluorophenyl)cyclopropane -1,1-dicarboxamide, including a (L)-malate salt, a (D)-malate salt, a (DL) malate salt, and mixtures thereof; and crystalline and amorphous forms of the malate salts. Also disclosed are pharmaceutical compositions comprising at least one malate salts of N-(4-{[6,7-bis(methyloxy)quinolin-4-yl]oxy}phenyl)-N′-(4-fluorophenyl)-cyclopropane-1,1-dicarboxamide; and methods of treating cancer comprising administering at least one malate salt of N-(4-{[6,7-bis(methyloxy)quinolin-4-yl]oxy}phenyl)-N′-(4-ffuorophenyl)cyclopropane-1,1-dicarboxamide.

    Patent expiration dates:

    • October 8, 2030
      ✓ 
      Drug substance
      ✓ 
      Drug product
  • C-met modulator pharmaceutical compositions
    Patent 9,724,342
    Issued: August 8, 2017
    Assignee(s): Exelixis, Inc.

    Pharmaceutical compositions and unit dosage forms comprising Compound I are disclosed.

    Patent expiration dates:

    • July 9, 2033
      ✓ 
      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:

    • January 14, 2022 - TREATMENT OF PATIENTS WITH HEPATOCELLULAR CARCINOMA WHO HAVE BEEN PREVIOUSLY TREATED WITH SORAFENIB
    • January 22, 2024 - FOR THE TREATMENT OF PATIENTS WITH ADVANCED RENAL CELL CARCINOMA, AS A FIRST-LINE TREATMENT IN COMBINATION WITH NIVOLUMAB
    • January 14, 2026 -

Glossary

Term Definition
Drug Patent A 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 Exclusivity Exclusivity 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.
RLD A 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.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.