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Last Updated: May 26, 2022

ENTRECTINIB - Generic Drug Details


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What are the generic drug sources for entrectinib and what is the scope of freedom to operate?

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 fourteen patent family members in twenty-nine countries.

One supplier is listed for this compound.

Summary for ENTRECTINIB
International Patents:114
US Patents:14
Tradenames:1
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 48
Clinical Trials: 28
Patent Applications: 980
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
Oregon Health and Science UniversityPhase 2
OHSU Knight Cancer InstitutePhase 2
Helsinki University Central HospitalPhase 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 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 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 212725-001 Aug 15, 2019 RX Yes No 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

International Patents for ENTRECTINIB

Country Patent Number Title Estimated Expiration
Ukraine 118773 СПОЛУКИ ДЛЯ ЛІКУВАННЯ ПАЦІЄНТІВ З ROS1-МУТАНТНИМИ РАКОВИМИ КЛІТИНАМИ (COMPOUNDS FOR TREATING PATIENTS WITH ROS1 MUTANT CANCER CELLS) See Plans and Pricing
Mexico 2016010519 MOLECULAS PARA ADMINISTRACION A CELULAS CANCEROSAS MUTANTES ROS1. (COMPOUNDS FOR TREATING PATIENTS WITH ROS1 MUTANT CANCER CELLS.) See Plans and Pricing
Taiwan I672141 See Plans and Pricing
Canada 2933623 COMPOSES POUR TRAITER DES PATIENTS PRESENTANT DES CELLULES CANCEREUSES MUTANTES ROS1 (COMPOUNDS FOR TREATING PATIENTS WITH ROS1 MUTANT CANCER CELLS) See Plans and Pricing
New Zealand 722405 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 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 2021C/522 Belgium See Plans and Pricing PRODUCT NAME: ENTRECTINIB IN ALLE VORMEN ZOALS BESCHERMD DOOR HET BASISOCTROOI; AUTHORISATION NUMBER AND DATE: EU/1/20/1460 20200803
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
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
3107541 122021000032 Germany See Plans and Pricing 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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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Dow
Express Scripts
Medtronic
AstraZeneca
Boehringer Ingelheim

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.