ENTRECTINIB - Generic Drug Details

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

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
Genentech Inc	ROZLYTREK	entrectinib	CAPSULE;ORAL	212725-001	Aug 15, 2019		RX	Yes	No			Y
Genentech Inc	ROZLYTREK	entrectinib	CAPSULE;ORAL	212725-002	Aug 15, 2019		RX	Yes	Yes
Genentech Inc	ROZLYTREK	entrectinib	CAPSULE;ORAL	212725-001	Aug 15, 2019		RX	Yes	No
Genentech Inc	ROZLYTREK	entrectinib	CAPSULE;ORAL	212725-001	Aug 15, 2019		RX	Yes	No

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)
Mexico	2016010519	MOLECULAS PARA ADMINISTRACION A CELULAS CANCEROSAS MUTANTES ROS1. (COMPOUNDS FOR TREATING PATIENTS WITH ROS1 MUTANT CANCER CELLS.)
Taiwan	I672141
Canada	2933623	COMPOSES POUR TRAITER DES PATIENTS PRESENTANT DES CELLULES CANCEREUSES MUTANTES ROS1 (COMPOUNDS FOR TREATING PATIENTS WITH ROS1 MUTANT CANCER CELLS)
New Zealand	722405	Compounds for treating patients with ros1 mutant cancer cells

Supplementary Protection Certificates for ENTRECTINIB

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2176231	122020000081	Germany		PRODUCT NAME: ENTRECTINIB ODER ISOMERE, TAUTOMERE ODER PHARMAZEUTISCH ANNEHMBARE SALZE DAVON; REGISTRATION NO/DATE: EU/1/20/1460 20200731
3107541	2021C/522	Belgium		PRODUCT NAME: ENTRECTINIB IN ALLE VORMEN ZOALS BESCHERMD DOOR HET BASISOCTROOI; AUTHORISATION NUMBER AND DATE: EU/1/20/1460 20200803
2176231	301090	Netherlands		PRODUCT NAME: ENTRECTINIB, DAN WEL TAUTOMEREN, OF FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/20/1460 20200803
2176231	C202030070	Spain		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		PRODUCT NAME: ENTRECTINIB IN ALLEN DEM GRUNDPATENT ZUGRUNDE LIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/20/1460 20200731