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 two NDAs. There are fourteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Entrectinib has one hundred and twenty-three patent family members in thirty countries.

One supplier is listed for this compound.

Summary for entrectinib

International Patents:	123
US Patents:	14
Tradenames:	1
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	59
Clinical Trials:	32
Patent Applications:	986
What excipients (inactive ingredients) are in entrectinib?	entrectinib excipients list
DailyMed Link:	entrectinib at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for entrectinib

Dosage:

CAPSULE;ORAL

Constraining patent/regulatory exclusivity:

TREATMENT OF PEDIATRIC PATIENTS OLDER THAN 1 MONTH UP TO 12 YEARS OF AGE WITH SOLID TUMORS THAT HAVE A NEUROTROPHIC TYROSINE RECEPTOR KINASE (NTRK) GENE FUSION, AS DETECTED BY AN FDA-APPROVED TEST WITHOUT A KNOWN ACQUIRED RESISTANCE MUTATION, ARE METASTATIC OR WHERE SURGICAL RESECTION IS LIKELY TO RESULT IN SEVERE MORBIDITY, AND HAVE PROGRESSED FOLLOWING TREATMENT OR HAVE NO SATISFACTORY ALTERNATIVE THERAPY

Dosage:

PELLETS;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for entrectinib

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Hunan Province Tumor Hospital	Phase 1/Phase 2
Royal Marsden NHS Foundation Trust	Phase 2/Phase 3
University of Manchester	Phase 2/Phase 3

See all entrectinib clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for entrectinib

L01EX	Other protein kinase inhibitors
L01E	PROTEIN KINASE INHIBITORS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

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	212725-001	Aug 15, 2019		RX	Yes	No			Y	Y
Genentech Inc	ROZLYTREK	entrectinib	CAPSULE;ORAL	212725-001	Aug 15, 2019		RX	Yes	No			Y
Genentech Inc	ROZLYTREK	entrectinib	CAPSULE;ORAL	212725-001	Aug 15, 2019		RX	Yes	No
Genentech Inc	ROZLYTREK	entrectinib	CAPSULE;ORAL	212725-002	Aug 15, 2019		RX	Yes	Yes			Y	Y
Genentech Inc	ROZLYTREK	entrectinib	PELLETS;ORAL	218550-001	Oct 20, 2023		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
Taiwan	200911233	Substituted indazole derivatives active as kinase inhibitors
Norway	2020042
World Intellectual Property Organization (WIPO)	2013174876
Australia	2017271458	New crystalline form of N-[5-(3,5-difluoro-benzyl)-1H-indazol-3-yl]-4-(4-methyl-piperazin-1-yl)-2-(tetrahydro-pyran-4-ylamino)-benzamide
Russian Federation	2602071	СПОСОБ ПОЛУЧЕНИЯ N-[5-(3,5-ДИФТОРБЕНЗИЛ)-1Н-ИНДАЗОЛ-3-ИЛ]-4-(4-МЕТИЛПИПЕРАЗИН-1-ИЛ)-2-(ТЕТРАГИДРОПИРАН-4-ИЛАМИНО)БЕНЗАМИДА (METHOD OF PRODUCING N-[5-(3,5-DIFTORBENZIL)-1H-INDAZOLE-3-YL]-4-(4-METHYLPIPERAZINE-1-YL)-2-(TETRAHYDROPYRAN-4-YLAMINO)BENZAMIDE)

Supplementary Protection Certificates for entrectinib

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2176231	2090052-8	Sweden		PRODUCT NAME: ENTRECTINIB OR TAUTOMERS, OR PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REG. NO/DATE: EU/1/20/1460 20200803
2176231	2020042	Norway		PRODUCT NAME: ENTREKTINIB ELLER ISOMERER TAUTOMERER, ELLER FARMASOEYTISK AKSEPTABLE SALTER DERAV; REG. NO/DATE: EU/1/20/1460 20200810
2176231	CA 2020 00058	Denmark		PRODUCT NAME: ENTRECTINIB ELLER ISOMERER, TAUTOMERER ELLER FARMACEUTISK ACCEPTABLE SALTE DERAF; REG. NO/DATE: EU/1/20/1460 20200803
3107541	2021C/522	Belgium		PRODUCT NAME: ENTRECTINIB IN ALLE VORMEN ZOALS BESCHERMD DOOR HET BASISOCTROOI; AUTHORISATION NUMBER AND 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