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VELCADE Drug Profile

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When do Velcade patents expire, and when can generic versions of Velcade launch?

Velcade is a drug marketed by Millennium Pharms and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has twenty-two patent family members in twelve countries.

The generic ingredient in VELCADE is bortezomib. There are twenty drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the bortezomib profile page.

Summary for VELCADE

International Patents:	22
US Patents:	2
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	88
Clinical Trials:	526
Patent Applications:	76
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for VELCADE
DailyMed Link:	VELCADE at DailyMed

Pharmacology for VELCADE

Drug Class	Proteasome Inhibitor
Mechanism of Action	Proteasome Inhibitors

Medical Subject Heading (MeSH) Categories for VELCADE

Antineoplastic Agents

Synonyms for VELCADE

((1R)-3-Methyl-1-(((2S)-3-phenyl-2-((pyrazinylcarbonyl)amino)propanoyl)amino)butyl)boronic acid

((R)-3-Methyl-1-((S)-3-phenyl-2-(pyrazine-2-carboxamido)propanamido)butyl)boronic acid

((R)-3-methyl-1-((S)-3-phenyl-2-(pyrazine-2-carboxamido)propanamido)butyl)boronicacid

(1R)-3-Methyl-1-({(2S)-3-phenyl-2-[(2-pyrazinylcarbonyl)amino]propanoyl}amino)butylboronic acid, AldrichCPR

(R)-3-METHYL-1-((S)-3-PHENYL-2-(PYRAZINE-2-CARBOXAMIDO)PROPANAMIDO)BUTAN-2-YLBORONIC ACID

(R)-3-methyl-1-((S)-3-phenyl-2-(pyrazine-2-carboxamido)propanamido)butylboronic acid

(R)-3-METHYL-1-((S)-3-PHENYL-2-(PYRAZINE-5-CARBOXAMIDO)PROPANAMIDO)BUTYLBORONIC ACID

(R)-3-methyl-1-((S)-3-phenyl-2-(pyrazine-6-carboxamido)propanamido)butylboronic acid

[(1R)-3-methyl-1-({(2S)-3-phenyl-2-[(pyrazin-2-ylcarbonyl)amino]propanoyl}amino)butyl]boronic acid

[(1R)-3-METHYL-1-[(2S)-3-PHENYL-2-(PYRAZIN-2-YLFORMAMIDO)PROPANAMIDO]BUTYL]BORONIC ACID

[(1R)-3-Methyl-1-[[(2S)-1-oxo-3-phenyl-2-[(pyrazinylcarbonyl)amino]propyl]amino]-butyl]boronic acid

[(1R)-3-METHYL-1-[[(2S)-1-OXO-3-PHENYL-2-[(PYRAZINYLCARBONYL)AMINO]PROPYL]AMINO]BUTYL]-BORONIC ACID

[(1R)-3-Methyl-1-[[(2S)-1-oxo-3-phenyl-2-[(pyrazinylcarbonyl)amino]propyl]amino]butyl]boronic acid

[(1R)-3-methyl-1-[[(2S)-3-phenyl-2-(pyrazine-2-carbonylamino)propanoyl]amino]butyl]boronic acid

179324-69-7

197730-97-5

324B697

3mg0

69G8BD63PP

AB0017579

AB01273951_03

AB01273951-01

AB01273951-02

AB2000734

ABP000234

AC1L8TUW

AK-33783

AKOS015909706

AM007968

AM81235

ANW-61718

AOB6368

API0001750

AS-15721

AX8106087

BC201423

BDBM50069989

Boronic acid, ((1R)-3-methyl-1-(((2S)-1-oxo-3-phenyl-2-((pyrazinylcarbonyl)amino)propyl)amino)butyl)-

Boronic acid, (3-methyl-1-((1-oxo-3-phenyl-2-((pyrazinylcarbonyl)amino)propyl)amino)butyl)-, (S-(R*,S*))-

Boronic acid, [(1(R)-3-methyl-1-[[(2S)-1-oxo-3-phenyl-2-[(pyrazinylcarbonyl)amino]propyl]amino]butyl]-

Boronic acid, B-[(1R)-3-methyl-1-[[(2S)-1-oxo-3-phenyl-2-[(2-pyrazinylcarbonyl)amino]propyl]amino]butyl]-

Bortezomib

Bortezomib (JAN/USAN/INN)

Bortezomib (Proteasome inhibitor)

Bortezomib (PS-341)

Bortezomib (Velcade MG-341 PS-341)

Bortezomib (Velcade)

Bortezomib [USAN:INN:BAN]

Bortezomib,Velcade

Bortezomib(JAN/USAN/INN)

Bortezomib/Velcade, MG-341, PS-341

BOSUTINB

C19H25BN4O4

CAS-179324-69-7

CB0261

cc-75

CHEBI:52717

CHEMBL325041

CS-1039

CTK8B8979

D03150

D0SH3I

DB00188

DPBA

DR002191

DSSTox_CID_20980

DSSTox_GSID_40980

DSSTox_RID_79609

DTXSID3040980

FT-0082488

FT-0602235

GTPL6391

GXJABQQUPOEUTA-RDJZCZTQSA-N

HSDB 7666

HY-10227

I14-3268

KB-48452

KS-00000761

LDP 341

LDP-341

LPD 341

LPD-341

MFCD09056737

MG 341

MG-341

MG-341; PS-341

MLN-341

MLS004774142

MolPort-003-845-298

N-((1S)-1-Benzyl-2-(((1R)-1-(dihydroxyboranyl)-3-methylbutyl)amino)-2-oxoethyl)pyrazinecarboxamide

N-((1S)-1-benzyl-2-(((1R)-1-(dihydroxyboranyl)-3-methylbutyl)amino)2-oxoethylpyrazinecarboxamide

N-[(1R)-1-(dihydroxyboranyl)-3-methylbutyl]-N(alpha)-(pyrazin-2-ylcarbonyl)-L-phenylalaninamide

N-[(1R)-1-(dihydroxyboranyl)-3-methylbutyl]-Nalpha-(pyrazin-2-ylcarbonyl)-L-phenylalaninamide

N-[(1R)-1-(DIHYDROXYBORYL)-3-METHYLBUTYL]-N-(PYRAZIN-2-YLCARBONYL)-L-PHENYLALANINAMIDE

NCGC00168751-01

NCGC00181022-01

NCGC00242506-01

NCGC00242506-02

NCI60_029010

NSC 681239

NSC-681239

NSC681239

PB14673

PROSCRIPT BORONIC ACID

Ps 341

PS 341 (pharmaceutical)

PS-341

PubChem17777

Pyz-Phe-boroLeu

Q-4365

Q425

radiciol

RL02288

RT-000308

S1013

SBB071337

SC-23571

SCHEMBL192129

SMR003500787

SR-01000939863

SR-01000939863-2

ST2406732

Tox21_112630

Tox21_112672

Tox21_112672_1

UNII-69G8BD63PP

Velcade (Millenium)

Velcade (TN)

Velcade, MG-341, PS-341, Bortezomib

Velcade, MG-341, PS-341,179324-69-7

Velcade, Radiciol

ZINC169746649

US Patents and Regulatory Information for VELCADE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Millennium Pharms	VELCADE	bortezomib	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	021602-001	May 13, 2003		RX	Yes	Yes					Y
Millennium Pharms	VELCADE	bortezomib	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	021602-001	May 13, 2003		RX	Yes	Yes
Millennium Pharms	VELCADE	bortezomib	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	021602-001	May 13, 2003		RX	Yes	Yes
Millennium Pharms	VELCADE	bortezomib	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	021602-001	May 13, 2003		RX	Yes	Yes

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Expired US Patents for VELCADE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Millennium Pharms	VELCADE	bortezomib	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	021602-001	May 13, 2003
Millennium Pharms	VELCADE	bortezomib	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	021602-001	May 13, 2003
Millennium Pharms	VELCADE	bortezomib	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	021602-001	May 13, 2003
Millennium Pharms	VELCADE	bortezomib	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	021602-001	May 13, 2003

Paragraph IV (Patent) Challenges for VELCADE

Drugname	Dosage	Strength	RLD	Date
	For Injection	3.5 mg/vial

Non-Orange Book US Patents for VELCADE

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
6,699,835	Formulation of boronic acid compounds
7,109,323	Formulation of boronic acid compounds

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International Patents for VELCADE

Country	Document Number	Estimated Expiration
Germany	60239384
Japan	4162491
European Patent Office	1360189
Japan	2004517931

Supplementary Protection Certificates for VELCADE

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
C0014	France		PRODUCT NAME: BORTEZOMIB; REGISTRATION NO/DATE: EU/1/04/274/001 20040426
C/GB04/021	United Kingdom		PRODUCT NAME: BORTEZOMIB OR PHARMACEUTICALLY ACCEPTABLE ESTER THEREOF, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/04/274/001 20040428