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Last Updated: February 7, 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
OHSU Knight Cancer InstitutePhase 2
Oregon Health and Science UniversityPhase 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 212725-002 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 212725-002 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 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
China 110913842 包括恩曲替尼的药物组合物 (PHARMACEUTICAL COMPOSITIONS COMPRISING ENTRECTINIB) See Plans and Pricing
Russian Federation 2014151565 СПОСОБ ПОЛУЧЕНИЯ N-[5-(3,5-ДИФТОРБЕНЗИЛ)-1Н-ИНДАЗОЛ-3-ИЛ]-4-(4-МЕТИЛПИПЕРАЗИН-1-ИЛ)-2-(ТЕТРАГИДРОПИРАН-4-ИЛАМИНО)БЕНЗАМИДА See Plans and Pricing
Canada 3069339 COMPOSITIONS PHARMACEUTIQUES CONTENANT DE L'ENTRECTINIB (PHARMACEUTICAL COMPOSITIONS COMPRISING ENTRECTINIB) See Plans and Pricing
Taiwan 201907924 Pharmaceutical compositions and dosage forms 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 C02176231/01 Switzerland See Plans and Pricing PRODUCT NAME: ENTRECTINIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67280 05.11.2020
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
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 C202030070 Spain See Plans and Pricing PRODUCT NAME: ENTRECTINIB O SUS ISOMEROS, TAUTOMEROS, O SALES FARMACEUTICAMENTE ACEPTABLES.; NATIONAL AUTHORISATION NUMBER: EU/1/20/1460; DATE OF AUTHORISATION: 20200731; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/20/1460; DATE OF FIRST AUTHORISATION IN EEA: 20200731
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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