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Vemurafenib - Generic Drug Details

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What are the generic sources for vemurafenib and what is the scope of vemurafenib freedom to operate?

Vemurafenib is the generic ingredient in one branded drug marketed by Hoffmann La Roche and is included in one NDA. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Vemurafenib has one hundred and eighty-two patent family members in forty-four countries.

One supplier is listed for this compound.

Summary for vemurafenib

International Patents:	182
US Patents:	6
Tradenames:	1
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	95
Clinical Trials:	115
Patent Applications:	195
Formulation / Manufacturing:	see details
DailyMed Link:	vemurafenib at DailyMed

Pharmacology for vemurafenib

Drug Class	Kinase Inhibitor
Mechanism of Action	Protein Kinase Inhibitors Cytochrome P450 1A2 Inhibitors P-Glycoprotein Inhibitors

Synonyms for vemurafenib

[(2S,5R)-2,5-Dimethyl-4-[(tetrahydro-2H-pyran-4-yl)methyl]-1-piperazinyl][3-[(5-fluoro-2-methyl-4-pyrimidinyl)amino]-4,6-dihydro-6,6 -dimethylpyrrolo[3,4-c]pyrazol-5(1H)-yl]methanone

1-Propanesulfonamide, N-(3-((5-(4-chlorophenyl)-1H-pyrrolo(2,3-b)pyridin-3- yl)carbonyl)-2,4-difluorophenyl)-

1-PROPANESULFONAMIDE, N-[3-[[5-(4-CHLOROPHENYL)-1H-PYRROLO[2,3-B]PYRIDIN-3-YL]CARBONYL]-2,4-DIFLUOROPHENYL]-

1029872-54-5

207SMY3FQT

3og7

4CA-1032

918504-65-1

A25476

AB0031775

AB01273970_03

AB01273970-01

AB1009703

ABP000429

AC-25010

ACN-030372

AK-56796

AKOS007930804

AM81259

AN-1313

ANW-69692

AOB87705

AX8212389

BC626573

BDBM50396483

BRAF(V600E) Kinase Inhibitor RO5185426

BRD-K56343971-001-02-3

C23H18ClF2N3O3S

CHEBI:63637

CHEMBL1229517

CS-0216

CTK8C3113

D09996

D0Y9EW

DB08881

DTXSID50238710

EX-A053

EX-A1335

FT-0660388

FT-0675792

FT-0689782

GPXBXXGIAQBQNI-UHFFFAOYSA-N

GTPL5893

HE070213

HE290987

HE413595

HMS3265M03

HMS3265M04

HMS3265N03

HMS3265N04

HMS3654P09

HSDB 8143

HY-12057

IN2235

J-522975

J-690009

KB-59765

KS-0000002Q

MCULE-7244406627

ME-0096

MFCD18074504

MolPort-009-200-481

N-(3-((5-(4-Chlorophenyl)-1H-pyrrolo(2,3-b)pyridin-3-yl)carbonyl)-2,4- difluorophenyl)propane-1-sulfonamide

n-(3-((5-(4-chlorophenyl)-1h-pyrrolo(2,3-b)pyridin-3-yl)carbonyl)-2,4-difluorophenyl)-1-propanesulfonamide

N-(3-([5-(4-CHLOROPHENYL)-1H-PYRROLO[2,3-B]PYRIDIN-3-YL]CARBONYL)-2,4-DIFLUOROPHENYL)PROPANE-1-SULFONAMIDE

N-(3-(5-(4-Chlorophenyl)-1H-pyrrolo[2,3-B]pyridine

N-(3-(5-(4-chlorophenyl)-1H-pyrrolo[2,3-b]pyridine-3-carbonyl)-2,4-difluorophenyl)-propane-1-sulfonamide

N-(3-(5-(4-Chlorophenyl)-1H-pyrrolo[2,3-b]pyridine-3-carbonyl)-2,4-difluorophenyl)propane-1-sulfonamide

N-(3-{(5-(4-chlorophenyl)-1H-pyrrolo(2,3-b)pyridin-3-yl)carbonyl}-2,4- difluorophenyl)propane-1-sulfonamide

N-(3-{[5-(4-chlorophenyl)-1H-pyrrolo[2,3-b]pyridin-3-yl]carbonyl}-2,4-difluorophenyl)propane-1-sulfonamide

N-[3-[[5-(4-Chlorophenyl)-1H-pyrrolo[2,3-b]pyridin-3-yl]carbonyl]-2,4-difluorophenyl]-1-PropanesulfonaMide

N-[3-[5-(4-chlorophenyl)-1H-pyrrolo[2,3-b]pyridine-3-carbonyl]-2,4-difluoro-phenyl]propane-1-sulfonamide

N-{3-[5-(4-chlorophenyl)-1H-pyrrolo[2,3-b]pyridine-3-carbonyl]-2,4-difluorophenyl}propane-1-sulfonamide

NCGC00250399-01

NSC-761431

NSC761431

PB11741

PLX 4032

PLX-4032

PLX-4032(RG7204)/PLX4032

PLX4032

PLX4032 - Vemurafenib

PLX4032 ,Vemurafenib ,

PLX4032 (Vemurafenib)

PLX4032, RG7204, RO5185426, 1029872-54-5

PLX4032,Vemurafenib, RG7204, RO5185426, Zelboraf

propane-1-sulfonic acid {3-[5-(4-chloro-phenyl)-1h-pyrrolo[2,3-b]pyridine-3-carbonyl]-2,4-difluoro-phenyl}-amide

Q-3409

QCR-44

R-7204

RG 7204

RG-7204

RG7204

RL05788

Ro 51-85426

RO 5185426

RO-5185426

RO5185426

s1267

SC-54548

SCHEMBL298931

SR-01000941568

SR-01000941568-1

ST24048327

SYN1161

TC-158437

TRA0082406

UNII-207SMY3FQT

Vemurafenib (BRAF inhibitor)

Vemurafenib (JAN/USAN/INN)

Vemurafenib (PLX4032, RG7204)

Vemurafenib (PLX4032)

Vemurafenib [USAN:INN]

Vemurafenib, RG7204, RO5185426

Vemurafenib;PLX-4032

vemurafenibum

Y0473

Zelboraf

Zelboraf (TN)

ZINC52509366

ZX-AFC000306

US Patents and Regulatory Information for vemurafenib

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hoffmann La Roche	ZELBORAF	vemurafenib	TABLET;ORAL	202429-001	Aug 17, 2011		RX	Yes	Yes
Hoffmann La Roche	ZELBORAF	vemurafenib	TABLET;ORAL	202429-001	Aug 17, 2011		RX	Yes	Yes
Hoffmann La Roche	ZELBORAF	vemurafenib	TABLET;ORAL	202429-001	Aug 17, 2011		RX	Yes	Yes			Y	Y
Hoffmann La Roche	ZELBORAF	vemurafenib	TABLET;ORAL	202429-001	Aug 17, 2011		RX	Yes	Yes
Hoffmann La Roche	ZELBORAF	vemurafenib	TABLET;ORAL	202429-001	Aug 17, 2011		RX	Yes	Yes			Y
Hoffmann La Roche	ZELBORAF	vemurafenib	TABLET;ORAL	202429-001	Aug 17, 2011		RX	Yes	Yes

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Non-Orange Book US Patents for vemurafenib

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
7,846,941	Compounds modulating c-kit and c-fms activity and uses therefor
8,415,469	Compounds and methods for kinase modulation, and indications therefor
9,663,517	Compositions and uses thereof
8,067,434	Compounds and methods for development of Ret modulators
8,329,724	Process for the manufacture of pharmaceutically active compounds
8,530,661	Process for the manufacture of pharmaceutically active compounds

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International Patents for vemurafenib

Country	Document Number	Estimated Expiration
Japan	2013510813
Argentina	078033
Canada	2778693
South Korea	20120055586
Costa Rica	20170089
China	103601725

Supplementary Protection Certificates for vemurafenib

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1893612/01	Switzerland		PRODUCT NAME: VEMURAFENIB; REGISTRATION NO/DATE: SWISSMEDIC 62139 18.10.2011
2	Finland
2012010,C1893612	Lithuania		PRODUCT NAME: VEMURAFENIBUM; REGISTRATION NO/DATE: EU/1/12/751/001 20120217
2012010	Lithuania		PRODUCT NAME: VEMURAFENIBUM; REGISTRATION NO/DATE: EU/1/12/751/001 20120217
C/GB12/021	United Kingdom		PRODUCT NAME: VEMURAFENIB AND PHARMACEUTICALLY ACCEPTABLE SALTS; REGISTERED: UK EU/1/12/751/001 20120221
C0040	France		PRODUCT NAME: VEMURAFENIB, EVENTUELLEMENT SOUS LA FORME D'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/12/751/001 20120217