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Entrectinib - Generic Drug Details

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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 ten patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Entrectinib has seventy-five patent family members in twenty-seven countries.

One supplier is listed for this compound.

Summary for entrectinib

International Patents:	75
US Patents:	10
Tradenames:	1
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	38
Clinical Trials:	10
Patent Applications:	91
DailyMed Link:	entrectinib at DailyMed

Recent Clinical Trials for entrectinib

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

Sponsor	Phase
Hoffmann-La Roche	Phase 1
National Cancer Institute (NCI)	Phase 2
Alliance for Clinical Trials in Oncology	Phase 2

See all entrectinib clinical trials

Synonyms for entrectinib

1108743-60-7

AK547001

B5859

BCP16174

Benzamide, N-(5-((3,5-difluorophenyl)methyl)-1H-indazol-3-yl)-4-(4-methyl-1-piperazinyl)-2-((tetrahydro-2H-pyran-4-yl)amino)-

Benzamide, N-[5-[(3,5-difluorophenyl)methyl]-1H-indazol-3-yl]-4-(4-methyl-1-piperazinyl)-2-[(tetrahydro-2H-pyran-4-yl)amino]-

CHEMBL1983268

D10926

DA-47850

DB11986

Entrectinib (JAN/USAN/INN)

Entrectinib (RXDX-101)

Entrectinib [USAN:INN]

entrectinib-rxdx-101

Entrectinib, 95%

Entrectinib; NMS-E628

Entrectinib(rxdx-101)

EX-A2261

FT-0736318

GTPL8290

HAYYBYPASCDWEQ-UHFFFAOYSA-N

HY-12678

Kinome_2659

KS-00000TSK

L5ORF0AN1I

MFCD28129099

N-(5-(3,5-difluorobenzyl)-1H-indazol-3-yl)-4-(4-methylpiperazin-1-yl)-2-(tetrahydro-2H-pyran-4-ylamino)benzamide

N-(5-(3,5-Difluorobenzyl)-1H-indazol-3-yl)-4-(4-methylpiperazin-1yl)-2-(tetrahydro-2H-pyran-4-ylamino)benzamide

N-[5-(3,5-Difluoro-benzyl)-1H-indazol-3-yl]-4-(4-methyl-piperazin-1-yl)-2-(tetrahydro-pyran-4-ylamino)-benzamide

N-[5-[(3,5-difluorophenyl)methyl]-1H-indazol-3-yl]-4-(4-methylpiperazin-1-yl)-2-(oxan-4-ylamino)benzamide

N-{5-[(3,5-difluorophenyl)methyl]-1H-indazol-3-yl}-4-(4-methylpiperazin-1-yl)-2-[(oxan-4-yl)amino]benzamide

N-{5-[(3,5-difluorophenyl)methyl]-3H-indazol-3-ylidene}-4-(4-methylpiperazin-1-yl)-2-[(oxan-4-yl)amino]benzamide

NCGC00484067-01

NCGC00484067-03

NMS-E-628

NMS-E628

Rozlytrek

RXDX-101

s7998

S900006830

SB17194

SCHEMBL3512601

UNII-L5ORF0AN1I

YMX

ZINC43204146

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	212725-001	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	212725-001	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	Estimated Expiration
Canada	2873979
Chile	2008002129
Poland	2176231
Eurasian Patent Organization	018503
World Intellectual Property Organization (WIPO)	2009013126