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Last Updated: January 19, 2022

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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 one NDA. There are thirteen patents protecting this drug.

This drug has one hundred and eleven 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:111
US Patents:13
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 50
Clinical Trials: 5
Patent Applications: 486
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
Helsinki University Central HospitalPhase 2
Hoffmann-La RochePhase 2
OHSU Knight Cancer InstitutePhase 1

See all ROZLYTREK clinical trials

US Patents and Regulatory Information for ROZLYTREK

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

Based on analysis by DrugPatentWatch, the earliest date for a generic version of ROZLYTREK is ⤷  Try it Free.

This potential generic entry date is based on patent ⤷  Try it Free.

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: ⤷  Try it Free
Patent Expiration: ⤷  Try it Free
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: ⤷  Try it Free
Patent Expiration: ⤷  Try it Free
Patented Use: TREATMENT OF ROS1-POSITIVE NON-SMALL CELL LUNG CANCER

Pharmaceutical compositions and dosage forms
Patent Number: ⤷  Try it Free
Patent Expiration: ⤷  Try it Free

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


Patent Number: ⤷  Try it Free
Patent Expiration: ⤷  Try it Free
Patented Use: TREATMENT OF ROS1-POSITIVE NON-SMALL CELL LUNG CANCER


Patent Number: ⤷  Try it Free
Patent Expiration: ⤷  Try it Free
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: ⤷  Try it Free
Patent Expiration: ⤷  Try it Free

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

Substituted indazole derivatives active as kinase inhibitors
Patent Number: ⤷  Try it Free
Patent Expiration: ⤷  Try it Free

Substituted indazole derivatives active as kinase inhibitors
Patent Number: ⤷  Try it Free
Patent Expiration: ⤷  Try it Free

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: ⤷  Try it Free
Patent Expiration: ⤷  Try it Free

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

Substituted indazole derivatives active as kinase inhibitors
Patent Number: ⤷  Try it Free
Patent Expiration: ⤷  Try it Free
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: ⤷  Try it Free
Patent Expiration: ⤷  Try it Free
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: ⤷  Try it Free
Patent Expiration: ⤷  Try it Free
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: ⤷  Try it Free

NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷  Try it Free

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: ⤷  Try it Free

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

Supplementary Protection Certificates for ROZLYTREK

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
3107541 21/2021 Austria ⤷  Try it Free PRODUCT NAME: ENTRECTINIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/20/1460 (MITTEILUNG) 20200803
2176231 122020000081 Germany ⤷  Try it Free PRODUCT NAME: ENTRECTINIB ODER ISOMERE, TAUTOMERE ODER PHARMAZEUTISCH ANNEHMBARE SALZE DAVON; REGISTRATION NO/DATE: EU/1/20/1460 20200731
2176231 132020000000164 Italy ⤷  Try it Free PRODUCT NAME: ENTRECTINIB O SUOI ISOMERI, TAUTOMERI O SALI FARMACEUTICAMENTE ACCETTABILI(ROZLYTREK); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/20/1460, 20200803
2176231 2020C/551 Belgium ⤷  Try it Free PRODUCT NAME: ENTRECTINIB OF ISOMEREN, TAUTOMEREN OF FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; AUTHORISATION NUMBER AND DATE: EU/1/20/1460 20200803
2176231 301090 Netherlands ⤷  Try it Free PRODUCT NAME: ENTRECTINIB, DAN WEL TAUTOMEREN, OF FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/20/1460 20200803
2176231 C02176231/01 Switzerland ⤷  Try it Free PRODUCT NAME: ENTRECTINIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67280 05.11.2020
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Merck
Express Scripts
AstraZeneca
Boehringer Ingelheim
Moodys
Colorcon

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.