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Last Updated: February 9, 2023

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 one NDA. There are fourteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Entrectinib has one hundred and seventeen patent family members in twenty-nine countries.

One supplier is listed for this compound.

Summary for entrectinib
International Patents:117
US Patents:14
Tradenames:1
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 56
Clinical Trials: 29
Patent Applications: 1,127
What excipients (inactive ingredients) are in entrectinib?entrectinib excipients list
DailyMed Link:entrectinib at DailyMed
Recent Clinical Trials for entrectinib

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

SponsorPhase
Taiho OncologyPhase 1
Oregon Health and Science UniversityPhase 2
OHSU Knight Cancer InstitutePhase 2

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 See Plans and Pricing See Plans and Pricing 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 212725-001 Aug 15, 2019 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Genentech Inc ROZLYTREK entrectinib CAPSULE;ORAL 212725-002 Aug 15, 2019 RX Yes Yes See Plans and Pricing See Plans and Pricing 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 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 Y Y 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 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
Israel 246544 תרכובת לטיפול בחולים עם תאי סרטן מוטנט ros1 (Compounds for treating patients with ros1 mutant cancer cells) See Plans and Pricing
South Korea 20150058568 키나제 억제제로서 활성인 치환된 인다졸 유도체 (SUBSTITUTED INDAZOLE DERIVATIVES ACTIVE AS KINASE INHIBITORS) See Plans and Pricing
European Patent Office 2855460 PROCÉDÉ DE PRÉPARATION DE N-[5-(3,5-DIFLUORO-BENZYL)-1H-INDAZOL-3-YL]-4-(4-METHYL-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
Eurasian Patent Organization 201691151 СОЕДИНЕНИЯ ДЛЯ ЛЕЧЕНИЯ ПАЦИЕНТОВ С ROS1-МУТАНТНЫМИ РАКОВЫМИ КЛЕТКАМИ See Plans and Pricing
Taiwan 200911233 Substituted indazole derivatives active as kinase inhibitors See Plans and Pricing
Ukraine 118773 СПОЛУКИ ДЛЯ ЛІКУВАННЯ ПАЦІЄНТІВ З ROS1-МУТАНТНИМИ РАКОВИМИ КЛІТИНАМИ (COMPOUNDS FOR TREATING PATIENTS WITH ROS1 MUTANT CANCER CELLS) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for entrectinib

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2176231 2090052-8 Sweden See Plans and Pricing PRODUCT NAME: ENTRECTINIB OR TAUTOMERS, OR PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REG. NO/DATE: EU/1/20/1460 20200803
2176231 CA 2020 00058 Denmark See Plans and Pricing PRODUCT NAME: ENTRECTINIB ELLER ISOMERER, TAUTOMERER ELLER FARMACEUTISK ACCEPTABLE SALTE DERAF; REG. NO/DATE: EU/1/20/1460 20200803
2176231 122020000081 Germany See Plans and Pricing PRODUCT NAME: ENTRECTINIB ODER ISOMERE, TAUTOMERE ODER PHARMAZEUTISCH ANNEHMBARE SALZE DAVON; REGISTRATION NO/DATE: EU/1/20/1460 20200731
3107541 132021000000107 Italy See Plans and Pricing 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 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
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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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