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Generic Rozlytrek Availability

Last updated on Nov 7, 2023.

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

ROZLYTREK (entrectinib - capsule;oral)

  • Manufacturer: GENENTECH INC
    Approval date: August 15, 2019
    Strength(s): 100MG [RLD], 200MG [RLD]

ROZLYTREK (entrectinib - pellets;oral)

  • Manufacturer: GENENTECH INC
    Approval date: October 20, 2023
    Strength(s): 50MG/PACKET [RLD]

Has a generic version of Rozlytrek been approved?

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

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

  • Molecules for administration to ROS1 mutant cancer cells
    Patent 10,231,965
    Issued: March 19, 2019
    Inventor(s): Lim Jonathan & Ardini Elena & Menichincheri Maria

    Substituted indazole derivatives of formula (I) or formula 2.(I) and pharmaceutically acceptable salts thereof, as defined in the specification, 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 deregulated protein kinase activity, like cancer.

    Patent expiration dates:

    • February 17, 2035
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      Patent use: TREATMENT OF SOLID TUMORS THAT HAVE A NEUROTROPHIC TYROSINE RECEPTOR KINASE (NTRK) GENE FUSION
    • February 17, 2035
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      Patent use: TREATMENT OF ROS1-POSITIVE NON-SMALL CELL LUNG CANCER
  • Pharmaceutical compositions and dosage forms
    Patent 10,398,693
    Issued: September 3, 2019
    Inventor(s): Codallos & Jr. Daniel & Orr Robert & Li Ching-Yuan & Start Valerie Denise
    Assignee(s): IGNYTA, INC.

    Disclosed herein are pharmaceutical compositions and dosage forms including N-[5-(3,5-difluorobenzyl)-1H-indazol-3-yl]-4-(4-methyl-piperazin-1-yl)-2-(tetrahydro-2H-pyran-4-ylamino) benzamide that are useful in the treatment of subjects having cancer. The present disclosure also provides methods for preparing these pharmaceutical compositions and dosage forms, and methods of treating subjects having cancer utilizing the pharmaceutical compositions and dosage forms provided herein.

    Patent expiration dates:

    • July 18, 2038
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      Drug product
  • Methods for treating neuroblastoma
    Patent 10,561,651
    Issued: February 18, 2020
    Inventor(s): Lim Jonathan & Ardini Elena & Menichincheri Maria

    Methods of treating neuroblastoma associated with a deregulated protein kinase activity are disclosed. The treatment may include administration of substituted indazole derivatives of formula (I) or formula 2.(I) and pharmaceutically acceptable salts therefor, as degined in the specification.

    Patent expiration dates:

    • February 19, 2035
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      Patent use: TREATMENT OF NEUROBLASTOMAS THAT HAVE A NEUROTROPHIC TYROSINE RECEPTOR KINASE (NTRK) GENE FUSION
  • Crystalline form of N-[5-(3,5-difluoro-benzyl)-1H-indazol-3-yl]-4-(4-methyl-piperazin-1-yl)-2-(tetrahydro-pyran-4-ylamino)-benzamide
    Patent 10,738,037
    Issued: August 11, 2020
    Inventor(s): Candiani Ilaria & Ottaiano Giovanni & Tomasi Attilio
    Assignee(s): NERVIANO MEDICAL SCIENCES S.R.L.

    The present invention relates to a new crystalline form of N-[5-(3,5-difluoro-benzyl)-1H-indazol-3-yl]-4-(4-methyl-piperazin-1-yl)-2-(tetrahydro-pyran-4-ylamino)-benzamide, process for its preparation, its utility in treating diseases caused by deregulated protein kinase activity and pharmaceutical compositions containing it.

    Patent expiration dates:

    • May 18, 2037
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      Patent use: TREATMENT OF COLORECTAL CANCER THAT HAS A NEUROTROPHIC TYROSINE RECEPTOR KINASE(NTRK) GENE FUSION
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      Drug substance
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      Drug product
  • Patent 11,091,469
    Issued: November 30, -0001

    Patent expiration dates:

    • May 18, 2037
      ✓ 
      Patent use: TREATMENT OF ROS1-POSITIVE NON-SMALL CELL LUNG CANCER
    • May 18, 2037
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      Patent use: TREATMENT OF SOLID TUMORS THAT HAVE A NEUROTROPHIC TYROSINE RECEPTOR KINASE (NTRK) GENE FUSION
  • Pharmaceutical compositions and dosage forms
    Patent 11,253,515
    Issued: February 22, 2022
    Inventor(s): Codallos & Jr. Daniel & Orr Robert & Li Ching-Yuan & Start Valerie Denise
    Assignee(s): Ignyta, Inc.

    Disclosed herein are pharmaceutical compositions and dosage forms including N-[5-(3,5-difluorobenzyl)-1H-indazol-3-yl]-4-(4-methyl-piperazin-1-yl)-2-(tetrahydro-2H-pyran-4-ylamino) benzamide that are useful in the treatment of subjects having cancer. The present disclosure also provides methods for preparing these pharmaceutical compositions and dosage forms, and methods of treating subjects having cancer utilizing the pharmaceutical compositions and dosage forms provided herein.

    Patent expiration dates:

    • July 18, 2038
      ✓ 
      Drug product
  • Substituted indazole derivatives active as kinase inhibitors
    Patent 8,299,057
    Issued: October 30, 2012
    Inventor(s): Lombardi Borgia Andrea & Menichincheri Maria & Orsini Paolo & Panzeri Achille & Perrone Ettore & Vanotti Ermes & Nesi Marcella & Marchionni Chiara
    Assignee(s): Nerviano Medical Sciences S.R.L.

    Substituted indazole derivatives of formula (I) and pharmaceutically acceptable salts thereof, as defined in the specification, 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 deregulated protein kinase activity, like cancer.

    Patent expiration dates:

    • March 1, 2029
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      Drug substance
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      Drug product
  • Substituted indazole derivatives active as kinase inhibitors
    Patent 8,673,893
    Issued: March 18, 2014
    Inventor(s): Lombardi Borgia Andrea & Menichincheri Maria & Orsini Paolo & Panzeri Achille & Perrone Ettore & Vanotti Ermes & Nesi Marcella & Marchionni Chiara
    Assignee(s): Nerviano Medical Sciences S.r.l.

    Substituted indazole derivatives of formula (I) and pharmaceutically acceptable salts thereof, as defined in the specification, 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 deregulated protein kinase activity, like cancer.

    Patent expiration dates:

    • July 8, 2028
      ✓ 
      Patent use: TREATMENT OF SOLID TUMORS THAT HAVE A NEUROTROPHIC TYROSINE RECEPTOR KINASE (NTRK) GENE FUSION
    • July 8, 2028
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      Patent use: TREATMENT OF ROS1-POSITIVE NON-SMALL CELL LUNG CANCER
  • Substituted indazole derivatives active as kinase inhibitors
    Patent 9,029,356
    Issued: May 12, 2015
    Inventor(s): Lombardi Borgia Andrea & Menichincheri Maria & Orsini Paolo & Panzeri Achille & Perrone Ettore & Vanotti Ermes & Nesi Marcella & Marchionni Chiara
    Assignee(s): Nerviano Medical Sciences S.R.L.

    Substituted indazole derivatives of formula (I) and pharmaceutically acceptable salts thereof, as defined in the specification; the compounds of the invention may be useful in therapy in the treatment of diseases associated with a deregulated protein kinase activity, like cancer.

    Patent expiration dates:

    • July 8, 2028
      ✓ 
      Drug substance
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      Drug product
  • Substituted indazole derivatives active as kinase inhibitors
    Patent 9,085,558
    Issued: July 21, 2015
    Inventor(s): Lombardi Borgia Andrea & Menichincheri Maria & Orsini Paolo & Panzeri Achille & Perrone Ettore & Vanotti Ermes & Nesi Marcella & Marchionni Chiara
    Assignee(s): NERVIANO MEDICAL SCIENCES S.R.L.

    Substituted indazole derivatives of formula (I) and pharmaceutically acceptable salts thereof, as defined in the specification; the compounds of the invention may be useful in therapy in the treatment of diseases associated with a deregulated protein kinase activity, like cancer.

    Patent expiration dates:

    • July 8, 2028
      ✓ 
      Drug product
  • Process for the preparation of N-[5-(3,5-difluoro-benzyl)-1H-indazol-3-yl]-4-(4-methyl-piperazin-1-yl)-2-(tetrahydro-pyran-4-ylamino)-benzamide
    Patent 9,085,565
    Issued: July 21, 2015
    Inventor(s): Barbugian Natale Alvaro & Forino Romualdo & Fumagalli Tiziano & Orsini Paolo
    Assignee(s): NERVIANO MEDICAL SCIENCES S.R.L.

    The present invention relates to a process for the preparation of N-[5-(3,5-difluoro-benzyl)-1H-indazol-3-yl]-4-(4-methyl-piperazin-1-yl)-2-(tetrahydro-pyran-4-ylamino)-benzamide. Novel solid forms of this compound, their utility in treating diseases caused by deregulated protein kinase activity and pharmaceutical compositions containing them are also object of the present invention.

    Patent expiration dates:

    • May 22, 2033
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      Drug substance
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      Drug product
  • Substituted indazole derivatives active as kinase inhibitors
    Patent 9,255,087
    Issued: February 9, 2016
    Inventor(s): Lombardi Borgia Andrea & Menichincheri Maria & Orsini Paolo & Panzeri Achille & Perrone Ettore & Vanotti Ermes & Nesi Marcella & Marchionni Chiara
    Assignee(s): NERVIANO MEDICAL SCIENCES S.R.L.

    Substituted indazole derivatives of formula (I) and pharmaceutically acceptable salts thereof, as defined in the specification; the compounds of the invention may be useful in therapy in the treatment of diseases associated with a deregulated protein kinase activity, like cancer.

    Patent expiration dates:

    • July 8, 2028
      ✓ 
      Patent use: TREATMENT OF SOLID TUMORS THAT HAVE A NEUROTROPHIC TYROSINE RECEPTOR KINASE (NTRK) GENE FUSION
    • July 8, 2028
      ✓ 
      Patent use: TREATMENT OF ROS1-POSITIVE NON-SMALL CELL LUNG CANCER
  • Substituted indazole derivatives active as kinase inhibitors
    Patent 9,616,059
    Issued: April 11, 2017
    Inventor(s): Lombardi Borgia Andrea & Menichincheri Maria & Orsini Paolo & Panzeri Achille & Perrone Ettore & Vanotti Ermes & Nesi Marcella & Marchionni Chiara
    Assignee(s): NERVIANO MEDICAL SCIENCES S.R.L.

    Substituted indazole derivatives of formula (I) and pharmaceutically acceptable salts thereof, as defined in the specification; the compounds of the invention may be useful in therapy in the treatment of diseases associated with a deregulated protein kinase activity, like cancer.

    Patent expiration dates:

    • July 8, 2028
      ✓ 
      Patent use: TREATMENT OF SOLID TUMORS THAT HAVE A NEUROTROPHIC TYROSINE RECEPTOR KINASE (NTRK) GENE FUSION
  • Treatment of diseases through administration of N-[5-(3,5-difluoro-benzyl)-1H-indazol-3-yl]-4-(4-methyl-piperazin-1-yl)-2-(tetrahydro-pyran-4-ylamino)-benzamide
    Patent 9,649,306
    Issued: May 16, 2017
    Inventor(s): Barbugian Natale Alvaro & Forino Romualdo & Fumagalli Tiziano & Orsini Paolo
    Assignee(s): NERVIANO MEDICAL SCIENCES S.R.L.

    The present invention relates to a process for the preparation of N-[5-(3,5-difluoro-benzyl)-1H-indazol-3-yl]-4-(4-methyl-piperazin-1-yl)-2-(tetrahydro-pyran-4-ylamino)-benzamide. Novel solid forms of this compound, their utility in treating diseases caused by deregulated protein kinase activity and pharmaceutical compositions containing them are also object of the present invention.

    Patent expiration dates:

    • May 22, 2033
      ✓ 
      Patent use: TREATMENT OF SOLID TUMORS THAT HAVE A NEUROTROPHIC TYROSINE RECEPTOR KINASE (NTRK) GENE FUSION
    • May 22, 2033
      ✓ 
      Patent use: TREATMENT OF ROS1-POSITIVE NON-SMALL CELL LUNG CANCER

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:

    • August 15, 2024 - NEW CHEMICAL ENTITY
    • August 15, 2026 - INDICATED FOR THE TREATMENT OF ADULT PATIENTS WITH METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WHOSE TUMORS ARE ROS1-POSITIVE
    • August 15, 2026 - INDICATED FOR THE TREATMENT OF ADULT AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER WITH SOLID TUMORS THAT HAVE A NEUROTROPHIC TYROSINE RECEPTOR KINASE (NTRK) GENE FUSION WITHOUT A KNOWN ACQUIRED RESISTANCE MUTATION, ARE METASTATIC OR WHERE SURGICAL RES

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.

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