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Last Updated: June 18, 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-three patent family members in thirty countries.

One supplier is listed for this compound.

Summary for entrectinib
International Patents:123
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 212725-001 Aug 15, 2019 RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Genentech Inc ROZLYTREK entrectinib CAPSULE;ORAL 212725-002 Aug 15, 2019 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 Y ⤷  Sign Up
Genentech Inc ROZLYTREK entrectinib CAPSULE;ORAL 212725-002 Aug 15, 2019 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 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
Argentina 067599 DERIVADOS DE INDAZOL SUSTITUIDO ACTIVOS COMO INHIBIDORES DE QUINASA ⤷  Sign Up
Israel 246544 תרכובת לטיפול בחולים עם תאי סרטן מוטנט ros1 (Compounds for treating patients with ros1 mutant cancer cells) ⤷  Sign Up
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) ⤷  Sign Up
Eurasian Patent Organization 201070167 ЗАМЕЩЕННЫЕ ПРОИЗВОДНЫЕ ИНДАЗОЛА, АКТИВНЫЕ КАК ИНГИБИТОРЫ КИНАЗЫ ⤷  Sign Up
European Patent Office 3290414 FORME CRISTALLINE DE N-[5-(3,5-DIFLUORO-BENZYL)-1H-INDAZOL-3-YL]-4-(4-MÉTHYL-PIPERAZIN-1-YL)-2-(TETRAHYDRO-PYRAN-4-YLAMINO)-BENZAMIDE (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) ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for entrectinib

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
3107541 132021000000107 Italy ⤷  Sign Up PRODUCT NAME: ENTRECTINIB IN TUTTE LE SUE FORME PROTETTE DAL BREVETTO DI BASE: ENTRECTINIB O SUOI ISOMERI, TAUTOMERI O SALI FARMACEUTICAMENTE ACCETTABILI(ROZLYTREK ); AUTHORISATION NUMBER(S) AND DATE(S): 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
2176231 2090052-8 Sweden ⤷  Sign Up PRODUCT NAME: ENTRECTINIB OR TAUTOMERS, OR PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REG. NO/DATE: EU/1/20/1460 20200803
2176231 122020000081 Germany ⤷  Sign Up PRODUCT NAME: ENTRECTINIB ODER ISOMERE, TAUTOMERE ODER PHARMAZEUTISCH ANNEHMBARE SALZE DAVON; REGISTRATION NO/DATE: EU/1/20/1460 20200731
3107541 122021000032 Germany ⤷  Sign Up 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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