Entrectinib - Generic Drug Details

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

Sponsor	Phase
Taiho Oncology	Phase 1
OHSU Knight Cancer Institute	Phase 2
Oregon Health and Science University	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			Y	Y
Genentech Inc	ROZLYTREK	entrectinib	CAPSULE;ORAL	212725-002	Aug 15, 2019		RX	Yes	Yes
Genentech Inc	ROZLYTREK	entrectinib	CAPSULE;ORAL	212725-002	Aug 15, 2019		RX	Yes	Yes			Y	Y
Genentech Inc	ROZLYTREK	entrectinib	CAPSULE;ORAL	212725-002	Aug 15, 2019		RX	Yes	Yes

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

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)
Russian Federation	2014151565	СПОСОБ ПОЛУЧЕНИЯ N-[5-(3,5-ДИФТОРБЕНЗИЛ)-1Н-ИНДАЗОЛ-3-ИЛ]-4-(4-МЕТИЛПИПЕРАЗИН-1-ИЛ)-2-(ТЕТРАГИДРОПИРАН-4-ИЛАМИНО)БЕНЗАМИДА
Canada	3069339	COMPOSITIONS PHARMACEUTIQUES CONTENANT DE L'ENTRECTINIB (PHARMACEUTICAL COMPOSITIONS COMPRISING ENTRECTINIB)
Taiwan	201907924	Pharmaceutical compositions and dosage forms

Supplementary Protection Certificates for entrectinib

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2176231	C02176231/01	Switzerland		PRODUCT NAME: ENTRECTINIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67280 05.11.2020
2176231	301090	Netherlands		PRODUCT NAME: ENTRECTINIB, DAN WEL TAUTOMEREN, OF FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/20/1460 20200803
3107541	21/2021	Austria		PRODUCT NAME: ENTRECTINIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/20/1460 (MITTEILUNG) 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