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Last Updated: May 25, 2024

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ROZLYTREK Drug Patent Profile


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Which patents cover Rozlytrek, and what generic alternatives are available?

Rozlytrek is a drug marketed by Genentech Inc and is included in two NDAs. There are fourteen patents protecting this drug.

This drug has one hundred and twenty-three patent family members in thirty countries.

The generic ingredient in ROZLYTREK is entrectinib. One supplier is listed for this compound. Additional details are available on the entrectinib profile page.

DrugPatentWatch® Generic Entry Outlook for Rozlytrek

Rozlytrek was eligible for patent challenges on August 15, 2023.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be October 20, 2030. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for ROZLYTREK
International Patents:123
US Patents:14
Applicants:1
NDAs:2
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 59
Clinical Trials: 9
Patent Applications: 473
Drug Prices: Drug price information for ROZLYTREK
What excipients (inactive ingredients) are in ROZLYTREK?ROZLYTREK excipients list
DailyMed Link:ROZLYTREK at DailyMed
Drug patent expirations by year for ROZLYTREK
Drug Prices for ROZLYTREK

See drug prices for ROZLYTREK

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for ROZLYTREK
Generic Entry Dates for ROZLYTREK*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
CAPSULE;ORAL
Generic Entry Dates for ROZLYTREK*:
Constraining patent/regulatory exclusivity:
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 METASTATIC OR WHERE SURGICAL RESECTION IS LIKELY TO RESULT IN SEVERE MORBIDITY, AND HAVE PROGRESSED FOLLOWING TREATMENT OR HAVE NO SATISFACTORY ALTERNATIVE THERAPY
NDA:
Dosage:
PELLETS;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for ROZLYTREK

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Cancer Research UKPhase 2/Phase 3
Royal Marsden NHS Foundation TrustPhase 2/Phase 3
University of ManchesterPhase 2/Phase 3

See all ROZLYTREK clinical trials

US Patents and Regulatory Information for ROZLYTREK

ROZLYTREK is protected by nineteen US patents and six FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of ROZLYTREK is ⤷  Sign Up.

This potential generic entry date is based on 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 METASTATIC OR WHERE SURGICAL RESECTION IS LIKELY TO RESULT IN SEVERE MORBIDITY, AND HAVE PROGRESSED FOLLOWING TREATMENT OR HAVE NO SATISFACTORY ALTERNATIVE THERAPY.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting ROZLYTREK

Molecules for administration to ROS1 mutant cancer cells
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF SOLID TUMORS THAT HAVE A NEUROTROPHIC TYROSINE RECEPTOR KINASE (NTRK) GENE FUSION

Molecules for administration to ROS1 mutant cancer cells
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF ROS1-POSITIVE NON-SMALL CELL LUNG CANCER

Pharmaceutical compositions and dosage forms
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Methods for treating neuroblastoma
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented 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 Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF COLORECTAL CANCER THAT HAS A NEUROTROPHIC TYROSINE RECEPTOR KINASE(NTRK) GENE FUSION


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF ROS1-POSITIVE NON-SMALL CELL LUNG CANCER


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF SOLID TUMORS THAT HAVE A NEUROTROPHIC TYROSINE RECEPTOR KINASE (NTRK) GENE FUSION

Pharmaceutical compositions and dosage forms
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Substituted indazole derivatives active as kinase inhibitors
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Substituted indazole derivatives active as kinase inhibitors
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF SOLID TUMORS THAT HAVE A NEUROTROPHIC TYROSINE RECEPTOR KINASE (NTRK) GENE FUSION

Substituted indazole derivatives active as kinase inhibitors
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF ROS1-POSITIVE NON-SMALL CELL LUNG CANCER

Substituted indazole derivatives active as kinase inhibitors
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Substituted indazole derivatives active as kinase inhibitors
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

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 Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Substituted indazole derivatives active as kinase inhibitors
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF SOLID TUMORS THAT HAVE A NEUROTROPHIC TYROSINE RECEPTOR KINASE (NTRK) GENE FUSION

Substituted indazole derivatives active as kinase inhibitors
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF ROS1-POSITIVE NON-SMALL CELL LUNG CANCER

Substituted indazole derivatives active as kinase inhibitors
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented 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 Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented 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 Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF ROS1-POSITIVE NON-SMALL CELL LUNG CANCER

FDA Regulatory Exclusivity protecting ROZLYTREK

INDICATED FOR THE TREATMENT OF ADULT PATIENTS WITH METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WHOSE TUMORS ARE ROS1-POSITIVE
Exclusivity Expiration: ⤷  Sign Up

NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷  Sign Up

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 RESECTION IS LIKELY TO RESULT IN SEVERE MORBIDITY, AND HAVE EITHER PROGRESSED FOLLOWING TREATMENT OR HAVE NO SATISFACTORY ALTERNATIVE THERAPY
Exclusivity Expiration: ⤷  Sign Up

NEW PATIENT POPULATION
Exclusivity Expiration: ⤷  Sign Up

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 METASTATIC OR WHERE SURGICAL RESECTION IS LIKELY TO RESULT IN SEVERE MORBIDITY, AND HAVE PROGRESSED FOLLOWING TREATMENT OR HAVE NO SATISFACTORY ALTERNATIVE THERAPY
Exclusivity Expiration: ⤷  Sign Up

NEW PRODUCT
Exclusivity Expiration: ⤷  Sign Up

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Genentech Inc ROZLYTREK entrectinib CAPSULE;ORAL 212725-002 Aug 15, 2019 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
Genentech Inc ROZLYTREK entrectinib PELLETS;ORAL 218550-001 Oct 20, 2023 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Genentech Inc ROZLYTREK entrectinib CAPSULE;ORAL 212725-002 Aug 15, 2019 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

EU/EMA Drug Approvals for ROZLYTREK

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Roche Registration GmbH  Rozlytrek entrectinib EMEA/H/C/004936
Rozlytrek as monotherapy is indicated for the treatment of adult and paediatric patients 12 years of age and older with solid tumours expressing a neurotrophic tyrosine receptor kinase (NTRK) gene fusion,who have a disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity, andwho have not received a prior NTRK inhibitorwho have no satisfactory treatment options.Rozlytrek as monotherapy is indicated for the treatment of adult patients with ROS1 positive, advanced non small cell lung cancer (NSCLC) not previously treated with ROS1 inhibitors.
Authorised no no no 2020-07-31
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for ROZLYTREK

When does loss-of-exclusivity occur for ROZLYTREK?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Patent: 18302170
Estimated Expiration: ⤷  Sign Up

Brazil

Patent: 2020000793
Estimated Expiration: ⤷  Sign Up

Canada

Patent: 69339
Estimated Expiration: ⤷  Sign Up

China

Patent: 0913842
Estimated Expiration: ⤷  Sign Up

European Patent Office

Patent: 54952
Estimated Expiration: ⤷  Sign Up

Israel

Patent: 1759
Estimated Expiration: ⤷  Sign Up

Japan

Patent: 03083
Estimated Expiration: ⤷  Sign Up

Patent: 20527575
Estimated Expiration: ⤷  Sign Up

South Korea

Patent: 200031115
Estimated Expiration: ⤷  Sign Up

Taiwan

Patent: 85074
Estimated Expiration: ⤷  Sign Up

Patent: 1907924
Estimated Expiration: ⤷  Sign Up

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering ROZLYTREK around the world.

Country Patent Number Title Estimated Expiration
Singapore 11201605816T COMPOUNDS FOR TREATING PATIENTS WITH ROS1 MUTANT CANCER CELLS ⤷  Sign Up
Ukraine 99141 ЗАМЕЩЕННЫЕ ПРОИЗВОДНЫЕ ИНДАЗОЛА, АКТИВНЫЕ В КАЧЕСТВЕ ИНГИБИТОРОВ КИНАЗЫ;ЗАМІЩЕНІ ПОХІДНІ ІНДАЗОЛУ, АКТИВНІ ЯК ІНГІБІТОРИ КІНАЗИ (SUBSTITUTED INDAZOLE DERIVATIVES ACTIVE AS KINASE INHIBITORS) ⤷  Sign Up
South Korea 102634514 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ROZLYTREK

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2176231 122020000081 Germany ⤷  Sign Up PRODUCT NAME: ENTRECTINIB ODER ISOMERE, TAUTOMERE ODER PHARMAZEUTISCH ANNEHMBARE SALZE DAVON; REGISTRATION NO/DATE: EU/1/20/1460 20200731
2176231 20C1064 France ⤷  Sign Up PRODUCT NAME: ENTRECTINIB OU SES TAUTOMERES OU SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/20/1460 20200803
2176231 2020042 Norway ⤷  Sign Up PRODUCT NAME: ENTREKTINIB ELLER ISOMERER TAUTOMERER, ELLER FARMASOEYTISK AKSEPTABLE SALTER DERAV; REG. NO/DATE: EU/1/20/1460 20200810
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.