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
Sponsor | Phase |
---|---|
Oregon Health and Science University | Phase 2 |
OHSU Knight Cancer Institute | Phase 2 |
Helsinki University Central Hospital | Phase 2 |
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 |