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Generic Braftovi Availability

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

BRAFTOVI (encorafenib - capsule;oral)

  • Manufacturer: ARRAY BIOPHARMA INC
    Approval date: June 27, 2018
    Strength(s): 50MG (discontinued) [RLD], 75MG [RLD]

Has a generic version of Braftovi been approved?

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

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

  • Compounds and compositions as protein kinase inhibitors
    Patent 10,005,761
    Issued: June 26, 2018
    Assignee(s): Array BioPharma Inc.

    The invention provides a novel class of compounds, pharmaceutical compositions comprising such compounds and methods of using such compounds to treat or prevent diseases or disorders associated with abnormal or deregulated kinase activity, particularly diseases or disorders that involve abnormal activation of B-Raf.

    Patent expiration dates:

    • August 27, 2030
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      Patent use: TREATMENT OF MELANOMA
    • August 27, 2030
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      Patent use: BRAFTOVI IS A KINASE INHIBITOR INDICATED IN COMBINATION WITH CETUXIMAB, FOR THE TREATMENT OF ADULT PATIENTS WITH METASTATIC COLORECTAL CANCER (CRC) WITH A BRAF V600E MUTATION, AS DETECTED BY AN FDA-APPROVED TEST, AFTER PRIOR THERAPY
    • August 27, 2030
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      Patent use: BRAFTOVI IS A KINASE INHIBITOR INDICATED IN COMBINATION WITH BINIMETINIB, FOR THE TREATMENT OF PATIENTS WITH UNRESECTABLE OR METASTATIC MELANOMA WITH A BRAF V600E OR V600K MUTATION, AS DETECTED BY AN FDA- APPROVED TEST
  • Method of treating colorectal cancer by administration of pharmaceutical formulations of (S)-methyl (1-((4-(3-(5-chloro-2-fluoro-3-(methylsulfonamido)pheny1)-1-isopropyl-1H-pyrazol-4-yl)pyrimidin-2-yl)amino)propan-2-yl) carbamate
    Patent 10,258,622
    Issued: April 16, 2019
    Assignee(s): Array BioPharma Inc.

    This invention relates to solid oral pharmaceutical formulations of (S)-methyl (1-((4-(3-(5-chloro-2-fluoro-3-(methyl-sulfonamido)phenyl)-1-isopropyl-1H-pyrazol-4-yl)pyrimidin-2-yl)amino)propan-2-yl)carbamate (COMPOUND A) and the use of these formulations for treating proliferative diseases, such as solid tumor diseases.

    Patent expiration dates:

    • November 21, 2032
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      Patent use: BRAFTOVI IS A KINASE INHIBITOR INDICATED IN COMBINATION WITH CETUXIMAB, FOR THE TREATMENT OF ADULT PATIENTS WITH METASTATIC COLORECTAL CANCER (CRC) WITH A BRAF V600E MUTATION, AS DETECTED BY AN FDA-APPROVED TEST, AFTER PRIOR THERAPY
  • Compounds and compositions as protein kinase inhibitors
    Patent 8,501,758
    Issued: August 6, 2013
    Assignee(s): IRM LLC Novartis AG

    The invention provides a novel class of compounds, pharmaceutical compositions comprising such compounds and methods of using such compounds to treat or prevent diseases or disorders associated with abnormal or deregulated kinase activity, particularly diseases or disorders that involve abnormal activation of B-Raf.

    Patent expiration dates:

    • March 4, 2031
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      Drug substance
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      Drug product
  • 3,4-diarylpyrazoles as protein kinase inhibitors
    Patent 8,541,575
    Issued: September 24, 2013
    Assignee(s): Nerviano Medical Sciences S.R.L.

    3,4-diarylpyrazole derivatives of formula (I) as defined in the specification, and pharmaceutically acceptable salts thereof, process for their preparation and pharmaceutical compositions comprising them are disclosed; the compounds of the invention may be useful, in therapy, in the treatment of diseases associated with a disregulated protein kinase activity, like cancer.

    Patent expiration dates:

    • February 26, 2030
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      Patent use: TREATMENT OF MELANOMA
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      Drug substance
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      Drug product
    • February 26, 2030
      ✓ 
      Patent use: BRAFTOVI IS A KINASE INHIBITOR INDICATED IN COMBINATION WITH BINIMETINIB, FOR THE TREATMENT OF PATIENTS WITH UNRESECTABLE OR METASTATIC MELANOMA WITH A BRAF V600E OR V600K MUTATION, AS DETECTED BY AN FDA- APPROVED TEST
      ✓ 
      Drug substance
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      Drug product
    • February 26, 2030
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      Patent use: BRAFTOVI IS A KINASE INHIBITOR INDICATED IN COMBINATION WITH CETUXIMAB, FOR THE TREATMENT OF ADULT PATIENTS WITH METASTATIC COLORECTAL CANCER (CRC) WITH A BRAF V600E MUTATION, AS DETECTED BY AN FDA-APPROVED TEST, AFTER PRIOR THERAPY
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      Drug substance
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      Drug product
  • 3,4-diarylpyrazoles as protein kinase inhibitors
    Patent 8,946,250
    Issued: February 3, 2015
    Assignee(s): Nerviano Medical Sciences S.R.L.

    3,4-diarylpyrazole derivatives of formula (I) as defined in the specification, and pharmaceutically acceptable salts thereof, process for their preparation and pharmaceutical compositions comprising them are disclosed; the compounds of the invention may be useful, in therapy, in the treatment of diseases associated with a disregulated protein kinase activity, like cancer.

    Patent expiration dates:

    • July 23, 2029
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      Drug substance
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      Drug product
  • Compounds and compositions as protein kinase inhibitors
    Patent 9,314,464
    Issued: April 19, 2016
    Assignee(s): Novartis AG

    The invention provides a novel class of compounds, pharmaceutical compositions comprising such compounds and methods of using such compounds to treat or prevent diseases or disorders associated with abnormal or deregulated kinase activity, particularly diseases or disorders that involve abnormal activation of B-Raf.

    Patent expiration dates:

    • July 4, 2031
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      Patent use: TREATMENT OF MELANOMA MEDIATED BY A B-RAF PROTEIN KINASE
    • July 4, 2031
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      Patent use: BRAFTOVI IS A KINASE INHIBITOR INDICATED IN COMBINATION WITH CETUXIMAB, FOR THE TREATMENT OF ADULT PATIENTS WITH METASTATIC COLORECTAL CANCER (CRC) WITH A BRAF V600E MUTATION, AS DETECTED BY AN FDA-APPROVED TEST, AFTER PRIOR THERAPY
    • July 4, 2031
      ✓ 
      Patent use: BRAFTOVI IS A KINASE INHIBITOR INDICATED IN COMBINATION WITH BINIMETINIB, FOR THE TREATMENT OF PATIENTS WITH UNRESECTABLE OR METASTATIC MELANOMA WITH A BRAF V600E OR V600K MUTATION, AS DETECTED BY AN FDA- APPROVED TEST
  • Pharmaceutical formulations of (S)-methyl (1-((4-(3-(5-chloro-2-fluoro-3-(methylsulfonamido)phenyl)-1-isopropyl-1H-pyrazol-4-yl)pyrimidin-2-yl)amino)propan-2-yl)carbamate
    Patent 9,387,208
    Issued: July 12, 2016
    Assignee(s): Novartis AG

    This invention relates to solid oral pharmaceutical formulations of (S)-methyl (1-((4-(3-(5-chloro-2-fluoro-3-(methylsulfonamido)phenyl)-1-isopropyl-1H-pyrazol-4-yl)pyrimidin-2-yl)amino)propan-2-yl)carbamate (COMPOUND A) and the use of the formulations for treating proliferative diseases, such as solid tumor diseases.

    Patent expiration dates:

    • November 21, 2032
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      Drug product
  • Pharmaceutical combinations comprising a B-RAF inhibitor, and EGFR inhibitor and optionally a PI3K-α inhibitor
    Patent 9,474,754
    Issued: October 25, 2016
    Assignee(s): NOVARTIS AG

    A pharmaceutical combination comprising (a) a B-Raf inhibitor, (b) a EGFR inhibitor and, optionally, (c) a PI3K inhibitor; the uses of such combination in the treatment of proliferative diseases; and methods of treating a subject suffering from a proliferative disease comprising administering a therapeutically effective amount of such combination.

    Patent expiration dates:

    • August 5, 2033
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      Patent use: BRAFTOVI IS A KINASE INHIBITOR INDICATED IN COMBINATION WITH CETUXIMAB, FOR THE TREATMENT OF ADULT PATIENTS WITH METASTATIC COLORECTAL CANCER (CRC) WITH A BRAF V600E MUTATION, AS DETECTED BY AN FDA-APPROVED TEST, AFTER PRIOR THERAPY
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      Drug product
  • Compounds and compositions as protein kinase inhibitors
    Patent 9,593,099
    Issued: March 14, 2017
    Assignee(s): Array BioPharma, Inc.

    The invention provides a novel class of compounds, pharmaceutical compositions comprising such compounds and methods of using such compounds to treat or prevent diseases or disorders associated with abnormal or deregulated kinase activity, particularly diseases or disorders that involve abnormal activation of B-Raf.

    Patent expiration dates:

    • August 27, 2030
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      Drug substance
  • Compounds and compositions as protein kinase inhibitors
    Patent 9,593,100
    Issued: March 14, 2017
    Assignee(s): Array BioPharma, Inc.

    The invention provides a novel class of compounds, pharmaceutical compositions comprising such compounds and methods of using such compounds to treat or prevent diseases or disorders associated with abnormal or deregulated kinase activity, particularly diseases or disorders that involve abnormal activation of B-Raf.

    Patent expiration dates:

    • August 27, 2030
      ✓ 
      Drug product
  • Method of treating melanoma by administration of pharmaceutical formulations of (S)-methyl (1-((4-(3-(5-chloro-2-fluoro-3-(methylsulfonamido)phenyl)-1-isopropyl-1H-pyrazol-4-yl)pyrimidin-2-yl)amino)propan-2-yl)carbamate
    Patent 9,763,941
    Issued: September 19, 2017
    Assignee(s): Array BioPharma, Inc.

    This invention relates to solid oral pharmaceutical formulations of (S)-methyl (1-((4-(3-(5-chloro-2-fluoro-3-(methyl -sulfonamido)phenyl)-1-isopropyl-1H-pyrazol-4-yl)pyrimidin-2-yl)amino)propan-2-yl)carbamate (COMPOUND A) and the use of these formulations for treating proliferative diseases, such as solid tumor diseases.

    Patent expiration dates:

    • November 21, 2032
      ✓ 
      Patent use: TREATMENT OF MELANOMA
  • Compounds and compositions as protein kinase inhibitors
    Patent 9,850,229
    Issued: December 26, 2017
    Assignee(s): Array BioPharma, Inc.

    The invention provides a novel class of compounds, pharmaceutical compositions comprising such compounds and methods of using such compounds to treat or prevent diseases or disorders associated with abnormal or deregulated kinase activity, particularly diseases or disorders that involve abnormal activation of B-Raf.

    Patent expiration dates:

    • August 27, 2030
      ✓ 
      Patent use: INDICATED IN COMBINATION WITH BINIMETINIB FOR THE TREATMENT OF MELANOMA WITH A BRAF MUTATION
  • Compounds and compositions as protein kinase inhibitors
    Patent 9,850,230
    Issued: December 26, 2017
    Assignee(s): Array BioPharma, Inc.

    The invention provides a novel class of compounds, pharmaceutical compositions comprising such compounds and methods of using such compounds to treat or prevent diseases or disorders associated with abnormal or deregulated kinase activity, particularly diseases or disorders that involve abnormal activation of B-Raf.

    Patent expiration dates:

    • August 27, 2030
      ✓ 
      Patent use: TREATMENT OF MELANOMA WITH A BRAF MUTATION
    • August 27, 2030
      ✓ 
      Patent use: BRAFTOVI IS A KINASE INHIBITOR INDICATED IN COMBINATION WITH CETUXIMAB, FOR THE TREATMENT OF ADULT PATIENTS WITH METASTATIC COLORECTAL CANCER (CRC) WITH A BRAF V600E MUTATION, AS DETECTED BY AN FDA-APPROVED TEST, AFTER PRIOR THERAPY
    • August 27, 2030
      ✓ 
      Patent use: BRAFTOVI IS A KINASE INHIBITOR INDICATED IN COMBINATION WITH BINIMETINIB, FOR THE TREATMENT OF PATIENTS WITH UNRESECTABLE OR METASTATIC MELANOMA WITH A BRAF V600E OR V600K MUTATION, AS DETECTED BY AN FDA- APPROVED TEST

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 8, 2023 - ENCORAFENIB, IN COMBINATION WITH CETUXIMAB, FOR THE TREATMENT OF ADULTPATIENTS WITH METASTATIC COLORECTAL CANCER WITH A BRAF V600E MUTATION, AS DETECTED BY AN FDA-APPROVED TEST, AFTER PRIOR THERAPY
    • June 27, 2023 - NEW CHEMICAL ENTITY
    • June 27, 2025 -

Further information

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

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.