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Last Updated: January 28, 2023

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 one NDA. There are fourteen patents protecting this drug.

This drug has one hundred and seventeen patent family members in twenty-nine 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 will be eligible for patent challenges on August 15, 2023. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be July 18, 2038. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for ROZLYTREK
International Patents:117
US Patents:14
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 53
Clinical Trials: 7
Patent Applications: 577
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 Generic Entry Opportunity Date for ROZLYTREK
Generic Entry Date for ROZLYTREK*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
CAPSULE;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
Genentech, Inc.Phase 1
Taiho OncologyPhase 1
Oregon Health and Science UniversityPhase 2

See all ROZLYTREK clinical trials

US Patents and Regulatory Information for ROZLYTREK

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

Based on analysis by DrugPatentWatch, the earliest date for a generic version of ROZLYTREK is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF ROS1-POSITIVE NON-SMALL CELL LUNG CANCER

Pharmaceutical compositions and dosage forms
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Methods for treating neuroblastoma
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF COLORECTAL CANCER THAT HAS A NEUROTROPHIC TYROSINE RECEPTOR KINASE(NTRK) GENE FUSION


Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF ROS1-POSITIVE NON-SMALL CELL LUNG CANCER


Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF SOLID TUMORS THAT HAVE A NEUROTROPHIC TYROSINE RECEPTOR KINASE (NTRK) GENE FUSION

Pharmaceutical compositions and dosage forms
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Substituted indazole derivatives active as kinase inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Substituted indazole derivatives active as kinase inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF ROS1-POSITIVE NON-SMALL CELL LUNG CANCER

Substituted indazole derivatives active as kinase inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Substituted indazole derivatives active as kinase inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Substituted indazole derivatives active as kinase inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF ROS1-POSITIVE NON-SMALL CELL LUNG CANCER

Substituted indazole derivatives active as kinase inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing

NEW CHEMICAL ENTITY
Exclusivity Expiration: See Plans and Pricing

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 RESISTENACE 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: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Genentech Inc ROZLYTREK entrectinib CAPSULE;ORAL 212725-002 Aug 15, 2019 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Genentech Inc ROZLYTREK entrectinib CAPSULE;ORAL 212725-002 Aug 15, 2019 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Genentech Inc ROZLYTREK entrectinib CAPSULE;ORAL 212725-001 Aug 15, 2019 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Genentech Inc ROZLYTREK entrectinib CAPSULE;ORAL 212725-001 Aug 15, 2019 RX Yes No See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Genentech Inc ROZLYTREK entrectinib CAPSULE;ORAL 212725-002 Aug 15, 2019 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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: See Plans and Pricing

Brazil

Patent: 2020000793
Estimated Expiration: See Plans and Pricing

Canada

Patent: 69339
Estimated Expiration: See Plans and Pricing

China

Patent: 0913842
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 54952
Estimated Expiration: See Plans and Pricing

Israel

Patent: 1759
Estimated Expiration: See Plans and Pricing

Japan

Patent: 20527575
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 200031115
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 1907924
Estimated Expiration: See Plans and Pricing

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
South Korea 20150016352 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 See Plans and Pricing
Mexico 2016010519 MOLECULAS PARA ADMINISTRACION A CELULAS CANCEROSAS MUTANTES ROS1. (COMPOUNDS FOR TREATING PATIENTS WITH ROS1 MUTANT CANCER CELLS.) See Plans and Pricing
Australia 2018201037 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 See Plans and Pricing
European Patent Office 3967689 NOUVELLE FORME CRISTALLINE DE N-[5-(3,5-DIFLUORO-BENZYL)-1H-INDAZOL-3-YL]-4-(4-MÉTHYL-PIPERAZIN-1-YL)-2-(TÉTRAHYDROPYRAN-4-YLAMINO)-BENZAMIDE (NEW CRYSTALLINE FORM OF N-[5-(3,5-DIFLUORO-BENZYL)-1H-INDAZOL-3-YL]-4-(4-METHYL-PIPERAZIN-1-YL)-2-(TETRAHYDROPYRAN-4-YLAMINO)-BENZAMIDE) See Plans and Pricing
Singapore 183049 SUBSTITUTED INDAZOLE DERIVATIVES ACTIVE AS KINASE INHIBITORS See Plans and Pricing
European Patent Office 3333166 PROCÉDÉ POUR LA PRÉPARATION DE N-[5-(3,5-DIFLUORO-BENZYL)-1H-INDAZOL-3-YL]-4-(4-MÉTHYL-PIPERAZIN-1-YL)-2-(TETRAHYDRO-PYRAN-4-YLAMINO)-BENZAMIDE (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) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ROZLYTREK

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2176231 301090 Netherlands See Plans and Pricing PRODUCT NAME: ENTRECTINIB, DAN WEL TAUTOMEREN, OF FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/20/1460 20200803
2176231 LUC00191 Luxembourg See Plans and Pricing PRODUCT NAME: ENTRECTINIB OU LES ISOMERES, TAUTOMERES, OU SELS PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/20/1460 20200803
3107541 21/2021 Austria See Plans and Pricing PRODUCT NAME: ENTRECTINIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/20/1460 (MITTEILUNG) 20200803
2176231 2020C/551 Belgium See Plans and Pricing PRODUCT NAME: ENTRECTINIB OF ISOMEREN, TAUTOMEREN OF FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; AUTHORISATION NUMBER AND DATE: EU/1/20/1460 20200803
2176231 132020000000164 Italy See Plans and Pricing PRODUCT NAME: ENTRECTINIB O SUOI ISOMERI, TAUTOMERI O SALI FARMACEUTICAMENTE ACCETTABILI(ROZLYTREK); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/20/1460, 20200803
3107541 122021000032 Germany See Plans and Pricing PRODUCT NAME: ENTRECTINIB IN ALLEN DEM GRUNDPATENT ZUGRUNDE LIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/20/1460 20200731
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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