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Last Updated: March 28, 2024

Entrectinib - Generic Drug Details


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What are the generic sources for entrectinib and what is the scope of patent protection?

Entrectinib is the generic ingredient in one branded drug marketed by Genentech Inc and is included in two NDAs. There are fourteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Entrectinib has one hundred and twenty-two patent family members in thirty countries.

One supplier is listed for this compound.

Summary for entrectinib
International Patents:122
US Patents:14
Tradenames:1
Applicants:1
NDAs:2
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 59
Clinical Trials: 31
Patent Applications: 986
What excipients (inactive ingredients) are in entrectinib?entrectinib excipients list
DailyMed Link:entrectinib at DailyMed
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for entrectinib
Generic Entry Dates for entrectinib*:
Constraining patent/regulatory exclusivity:
Dosage:
CAPSULE;ORAL
Generic Entry Dates for entrectinib*:
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
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 entrectinib

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

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

See all entrectinib clinical trials

US Patents and Regulatory Information for entrectinib

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 a Trial ⤷  Try a Trial ⤷  Try a Trial
Genentech Inc ROZLYTREK entrectinib CAPSULE;ORAL 212725-002 Aug 15, 2019 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Genentech Inc ROZLYTREK entrectinib CAPSULE;ORAL 212725-001 Aug 15, 2019 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Genentech Inc ROZLYTREK entrectinib CAPSULE;ORAL 212725-001 Aug 15, 2019 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Genentech Inc ROZLYTREK entrectinib CAPSULE;ORAL 212725-002 Aug 15, 2019 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Genentech Inc ROZLYTREK entrectinib CAPSULE;ORAL 212725-001 Aug 15, 2019 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Genentech Inc ROZLYTREK entrectinib CAPSULE;ORAL 212725-002 Aug 15, 2019 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
>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 entrectinib

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 entrectinib

Country Patent Number Title Estimated Expiration
Mexico 2018014298 NUEVA FORMA CRISTALINA DE N-[5-(3,5-DIFLUORO-BENCILO)-1H-INDAZOL-3 -IL]-4-(4-METILO-PIPERAZINA-1-IL)-2-(TETRAHIDRO-PIRANO-4-ILAMINO) -BENZAMIDA. (NEW CRYSTALLINE FORM OF N-[5-(3,5-DIFLUORO-BENZYL)-1H-INDAZOL-3-Y L]-4-(4-METHYL-PIPERAZIN-1-YL)-2-(TETRAHYDRO-PYRAN-4-YLAMINO)-BE NZAMIDE.) ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 2015124697 ⤷  Try a Trial
European Patent Office 3464276 NOUVELLE FORME CRISTALLINE DE N-[5-(3,5-DIFLUORO-BENZYL)-1H-INDAZOL-3-YL]-4-(4-MÉTHYL-PIPÉRAZIN-1-YL)-2-(TÉTRAHYDRO-PYRAN-4-YLAMINO)-BENZAMIDE (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) ⤷  Try a Trial
China 104395308 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 ⤷  Try a Trial
Taiwan 201400479 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 ⤷  Try a Trial
Singapore 11201605816T COMPOUNDS FOR TREATING PATIENTS WITH ROS1 MUTANT CANCER CELLS ⤷  Try a Trial
China 106167485 苯甲酰胺类,含有苯甲酰胺类的组合物以及苯甲酰胺类的制备方法 (Benzamide, compositions containing same, and preparation process thereof) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for entrectinib

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2176231 2020C/551 Belgium ⤷  Try a Trial PRODUCT NAME: ENTRECTINIB OF ISOMEREN, TAUTOMEREN OF FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; AUTHORISATION NUMBER AND DATE: EU/1/20/1460 20200803
2176231 LUC00191 Luxembourg ⤷  Try a Trial PRODUCT NAME: ENTRECTINIB OU LES ISOMERES, TAUTOMERES, OU SELS PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/20/1460 20200803
2176231 132020000000164 Italy ⤷  Try a Trial PRODUCT NAME: ENTRECTINIB O SUOI ISOMERI, TAUTOMERI O SALI FARMACEUTICAMENTE ACCETTABILI(ROZLYTREK); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/20/1460, 20200803
2176231 301090 Netherlands ⤷  Try a Trial PRODUCT NAME: ENTRECTINIB, DAN WEL TAUTOMEREN, OF FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/20/1460 20200803
2176231 C02176231/01 Switzerland ⤷  Try a Trial PRODUCT NAME: ENTRECTINIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67280 05.11.2020
2176231 46/2020 Austria ⤷  Try a Trial PRODUCT NAME: ENTRECTINIB ODER ISOMERE, TAUTOMERE ODER PHARMAZEUTISCH ANNEHMBARE SALZE DAVON; REGISTRATION NO/DATE: EU/1/20/1460 (MITTEILUNG) 20200803
2176231 122020000081 Germany ⤷  Try a Trial PRODUCT NAME: ENTRECTINIB ODER ISOMERE, TAUTOMERE ODER PHARMAZEUTISCH ANNEHMBARE SALZE DAVON; REGISTRATION NO/DATE: EU/1/20/1460 20200731
>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.