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Generic Vitrakvi Availability

Last updated on Sep 8, 2021.

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

VITRAKVI (larotrectinib sulfate - capsule;oral)

  • Manufacturer: BAYER HLTHCARE
    Approval date: November 26, 2018
    Strength(s): EQ 25MG BASE [RLD], EQ 100MG BASE [RLD]

VITRAKVI (larotrectinib sulfate - solution;oral)

  • Manufacturer: BAYER HEALTHCARE
    Approval date: November 26, 2018
    Strength(s): EQ 20MG BASE/ML [RLD]

Has a generic version of Vitrakvi been approved?

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

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

  • Method of treatment using substituted pyrazolo[1,5-a] pyrimidine compounds
    Patent 10,005,783
    Issued: June 26, 2018
    Assignee(s): Array BioPharma Inc.

    Compounds useful in the synthesis of compounds for treating pain, cancer, inflammation, neurodegenerative disease or Typanosoma cruzi infection in a mammal.

    Patent expiration dates:

    • October 21, 2029
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      Patent use: METHOD OF TREATING NEUROBLASTOMA, GLIOMA, THYROID, AND BREAST CANCER SOLID TUMORS THAT EXHIBIT AN NTRK GENE FUSION
  • Methods of treating pediatric cancers
    Patent 10,045,991
    Issued: August 14, 2018
    Assignee(s): Loxo Oncology, Inc.

    A method of treating a pediatric cancer in a subject in need thereof. The method includes administering to the subject a therapeutically effective amount of (S)—N-(5-((R)-2-(2,5-difluorophenyl)pyrrolidin-1-yl)-pyrazolo[1,5-a]pyrimidin-3-yl)-3-hydroxypyrrolidine-1-carboxamide, or a pharmaceutically acceptable salt thereof, or a combination thereof.

    Patent expiration dates:

    • April 4, 2037
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      Patent use: METHOD OF TREATING CMN, IFS, HGG, DIPGS, PTC, SOFT TISSUE SARCOMA, AND SPINDLE CELL SARCOMA SOLID TUMORS EXHIBITING AN NTRK GENE FUSION IN A PEDIATRIC PATIENT WITH AN ORAL SOLUTION
  • Method of treatment using substituted pyrazolo[1,5-a] pyrimidine compounds
    Patent 10,047,097
    Issued: August 14, 2018
    Assignee(s): Array BioPharma Inc.

    Compounds useful in the synthesis of compounds for treating pain, cancer, inflammation, neurodegenerative disease or Typanosoma cruzi infection in a mammal.

    Patent expiration dates:

    • October 21, 2029
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      Patent use: METHOD OF TREATING SOLID TUMORS THAT EXHIBIT AN NTRK GENE FUSION AFTER SURGICAL RESECTION
  • Liquid formulations of (S)-N-(5-((R)-2-(2,5-difluorophenyl)-pyrrolidin-1-yl)-pyrazolo[1,5-A]pyrimidin-3-yl)-3-hydroxypyrrolidine-1-carboxamide
    Patent 10,137,127
    Issued: November 27, 2018
    Assignee(s): Loxo Oncology, Inc.

    A liquid formulation of (S)—N-(5-((R)-2-(2,5-difluorophenyl)pyrrolidin-1-yl)-pyrazolo[1,5-a]pyrimidin-3-yl)-3-hydroxypyrrolidine-1-carboxamide, pharmaceutically acceptable salts thereof, or a combination thereof and the use of the liquid formulation in the treatment of pain, cancer, inflammation, and certain infectious diseases are disclosed.

    Patent expiration dates:

    • April 4, 2037
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      Drug product
  • Crystalline form of (S)-N-(5-((R)-2-(2,5-difluorophenyl)-pyrrolidin-1-yl)-pyrazolo[1,5-A]pyrimidin-3-yl)-3-hydroxypyrrolidine-1-carboxamide hydrogen sulfate
    Patent 10,172,861
    Issued: January 8, 2019
    Assignee(s): Array BioPharma Inc.

    A novel crystalline form of (S)-N-(5-((R)-2-(2,5-difluorophenyl)pyrrolidin-1-yl)-pyrazolo[1,5-a]pyrimidin-3-yl)-3-hydroxypyrrolidine-1-carboxamide, pharmaceutical compositions containing said crystalline form and the use of said crystalline form in the treatment of pain, cancer, inflammation, neurodegenerative disease or Trypanosoma cruzi infection are disclosed. In some embodiments, the novel crystalline form comprises a stable polymorph of (S)-N-(5-((R)-2-(2,5-difluorophenyl)pyrrolidin-1-yl)-pyrazolo[1,5-a]pyrimidin-3-yl)-3-hydroxypyrrolidine-1-carboxamide hydrogen sulfate. The present invention is further directed to a process for the preparation of the novel crystalline form.

    Patent expiration dates:

    • November 16, 2035
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      Drug substance
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      Drug product
    • November 16, 2035
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      Drug substance
  • Crystalline form of (S)-N-(5-((R)-2-(2,5-difluorophenyl)-pyrrolidin-1-yl)-pyrazolo[1,5-a]pyrimidin-3-yl)-3-hydroxypyrrolidine-1-carboxamide hydrogen sulfate
    Patent 10,285,993
    Issued: May 14, 2019
    Assignee(s): Array BioPharma Inc.

    A novel crystalline form of (S)-N-(5-((R)-2-(2,5-difluorophenyl)pyrrolidin-1-yl)-pyrazolo[1,5-a]pyrimidin-3-yl)-3-hydroxypyrrolidine-1-carboxamide, pharmaceutical compositions containing said crystalline form and the use of said crystalline form in the treatment of pain, cancer, inflammation, neurodegenerative disease or Trypanosoma cruzi infection are disclosed. In some embodiments, the novel crystalline form comprises a stable polymorph of (S)-N-(5-((R)-2-(2,5-difluorophenyl)pyrrolidin-1-yl)-pyrazolo[1,5-a]pyrimidin-3-yl)-3-hydroxypyrrolidine-1-carboxamide hydrogen sulfate. The present invention is further directed to a process for the preparation of the novel crystalline form.

    Patent expiration dates:

    • November 16, 2035
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      Patent use: METHOD OF TREATING SOLID TUMORS THAT EXHIBIT AN NTRK GENE FUSION
  • Patent 10,668,072

    Patent expiration dates:

    • April 4, 2037
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      Drug product
  • Patent 10,774,085

    Patent expiration dates:

    • October 21, 2029
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      Patent use: METHOD OF TREATING SOLID TUMORS THAT EXHIBIT AN NTRK GENE FUSION
  • Patent 10,799,505

    Patent expiration dates:

    • August 15, 2036
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      Drug substance
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      Drug product
    • August 15, 2036
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      Drug substance
  • Patent 10,813,936

    Patent expiration dates:

    • November 16, 2035
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      Patent use: METHOD OF TREATING LUNG CANCER, UNDIFFERENTIATED SARCOMA, OR COLORECTAL CANCER THAT EXHIBITS AN NTRK GENE FUSION
  • Substituted pyrazolo[1,5-a]pyrimidine compounds as Trk kinase inhibitors
    Patent 8,513,263
    Issued: August 20, 2013
    Assignee(s): Array BioPharma Inc.

    Compounds of Formula (I) in which R1, R2, R3, R4, X, Y and n have the meanings given in the specification, are inhibitors of Trk kinases and are useful in the treatment of diseases which can be treated with a Trk kinase inhibitor.

    Patent expiration dates:

    • December 23, 2029
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      Drug substance
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      Drug product
  • Method of treatment using substituted pyrazolo[1,5-a]pyrimidine compounds
    Patent 8,865,698
    Issued: October 21, 2014
    Assignee(s): Array BioPharma Inc.

    Provided herein are methods for treating pain, cancer, inflammation, neurodegenerative disease or Typanosoma cruzi infection in a mammal, which comprises administering to said mammal in need thereof a therapeutically effective amount of a compound of Formula I: in which R1, R2, R3, R4, X, Y and n have the meanings given in the specification.

    Patent expiration dates:

    • October 21, 2029
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      Patent use: METHOD OF TREATING CANCEROUS SOLID TUMORS
  • Method of treatment using substituted pyrazolo[1,5-a] pyrimidine compounds
    Patent 9,127,013
    Issued: September 8, 2015
    Assignee(s): Array BioPharma, Inc.

    Compounds useful in the synthesis of compounds for treating pain, cancer, inflammation, neurodegenerative disease or Typanosoma cruzi infection in a mammal.

    Patent expiration dates:

    • October 21, 2029
      ✓ 
      Drug substance
      ✓ 
      Drug product
  • Method of treatment using substituted pyrazolo[1,5-a]pyrimidine compounds
    Patent 9,447,104
    Issued: September 20, 2016
    Assignee(s): Array BioPharma, Inc.

    Compounds useful in the synthesis of compounds for treating pain, cancer, inflammation, neurodegenerative disease or Typanosoma cruzi infection in a mammal.

    Patent expiration dates:

    • October 21, 2029
      ✓ 
      Patent use: METHOD OF TREATING SOLID TUMORS THAT EXHIBIT AN NTRK GENE FUSION
  • Method of treatment using substituted pyrazolo[1,5-A] pyrimidine compounds
    Patent 9,676,783
    Issued: June 13, 2017
    Assignee(s): Array BioPharma, Inc.

    Compounds useful in the synthesis of compounds for treating pain, cancer, inflammation, neurodegenerative disease or Typanosoma cruzi infection in a mammal.

    Patent expiration dates:

    • October 21, 2029
      ✓ 
      Patent use: METHOD OF TREATING CANCEROUS SOLID TUMORS
  • Crystalline form of (S)-N-(5-((R)-2-(2,5-difluorophenyl)-pyrrolidin-1-yl)-pyrazolo[1,5-A]pyrimidin-3-yl)-3-hydroxypyrrolidine-1-carboxamide hydrogen sulfate
    Patent 9,782,414
    Issued: October 10, 2017
    Assignee(s): Array BioPharma, Inc.

    A novel crystalline form of (S)—N-(5-((R)-2-(2,5-difluorophenyl)pyrrolidin-1-yl)-pyrazolo[1,5-a]pyrimidin-3-yl)-3-hydroxypyrrolidine-1-carboxamide, pharmaceutical compositions containing said crystalline form and the use of said crystalline form in the treatment of pain, cancer, inflammation, neurodegenerative disease or Trypanosoma cruzi infection are disclosed. In some embodiments, the novel crystalline form comprises a stable polymorph of (S)—N-(5-((R)-2-(2,5-difluorophenyl)pyrrolidin-1-yl)-pyrazolo[1,5-a]pyrimidin-3-yl)-3-hydroxypyrrolidine-1-carboxamide hydrogen sulfate. The present invention is further directed to a process for the preparation of the novel crystalline form.

    Patent expiration dates:

    • November 16, 2035
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      Patent use: METHOD OF TREATING SOLID TUMORS THAT EXHIBIT AN NTRK GENE FUSION IN A PEDIATRIC PATIENT
    • November 16, 2035
      ✓ 
      Patent use: METHOD OF TREATING SOLID TUMORS THAT EXHIBIT AN NTRK FUSION GENE IN A PEDIATRIC PATIENT

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:

    • November 26, 2023 - NEW CHEMICAL ENTITY
    • November 26, 2025 -
    • November 26, 2025 -
    • November 26, 2025 -

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.