Generic Rozlytrek Availability

Last updated on Jan 8, 2025.

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.

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
Patent expiration dates:
- May 18, 2037
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  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
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  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
  ✓
  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
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  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 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
- August 15, 2026 - INDICATED FOR THE TREATMENT OF ADULT PATIENTS WITH METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WHOSE TUMORS ARE ROS1-POSITIVE
- October 20, 2026 - NEW PRODUCT
- October 20, 2026 - NEW PATIENT POPULATION
- October 20, 2030 - TREATMENT OF PEDIATRIC PATIENTS OLDER THAN 1 MONTH UP TO 12 YEARS OF AGE WITH SOLID TUMORS THAT HAVE A NEUROTROPHIC TYROSINE RECEPTOR KINASE (NTRK) GENE FUSION, AS DETECTED BY AN FDA-APPROVED TEST WITHOUT A KNOWN ACQUIRED RESISTANCE MUTATION, ARE METASTAT

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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

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Drug Status

Availability Prescription only Rx

Pregnancy & Lactation Risk data available

CSA Schedule* Not a controlled drug N/A

Approval History Drug history at FDA

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