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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-six patent family members in thirteen 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.

US ANDA Litigation and Generic Entry Outlook for Velcade

A generic version of VELCADE was launched as bortezomib by FRESENIUS KABI USA on December 14^th, 2019.

Summary for VELCADE

International Patents:	26
US Patents:	2
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	98
Clinical Trials:	548
Patent Applications:	76
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for VELCADE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for VELCADE
DailyMed Link:	VELCADE at DailyMed

See drug prices for VELCADE

Recent Clinical Trials for VELCADE

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

Sponsor	Phase
Takeda	Phase 2
Janssen Scientific Affairs, LLC	Phase 2
Janssen Pharmaceutica	Phase 2

See all VELCADE clinical trials

Recent Litigation for VELCADE

Identify potential future generic entrants

District Court Litigation

Case Name	Date
Millennium Pharmaceuticals, Inc. v. Hetero Labs Limited	2018-10-22
Millennium Pharmaceuticals, Inc. v. Qilu Pharmaceutical Co., Ltd.	2017-12-20
Millennium Pharmaceuticals Inc. v. Hospira, Inc.	2016-10-26

See all VELCADE litigation

Pharmacology for VELCADE

Drug Class	Proteasome Inhibitor
Mechanism of Action	Proteasome Inhibitors

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

(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)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)-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

AKOS015909706

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 (PS-341)

Bortezomib (Velcade MG-341 PS-341)

Bortezomib (Velcade)

Bortezomib [USAN:INN:BAN]

Bortezomib,Velcade

Bortezomib/Velcade, MG-341, PS-341

BRD-K88510285-001-02-0

C19H25BN4O4

CAS-179324-69-7

CB0261

cc-75

CHEBI:52717

CHEMBL325041

CS-1039

CTK8B8979

D03150

DB00188

DPBA

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

NCGC00242506-07

NCI60_029010

NSC 681239

NSC-681239

NSC681239

PB14673

PROSCRIPT BORONIC ACID

Ps 341

PS 341 (pharmaceutical)

PS 341; Velcade

PS-341

PubChem17777

Pyz-Phe-boroLeu

Q-4365

Q425

RL02288

RT-000308

S1013

SC-23571

SCHEMBL192129

SMR003500787

SR-01000939863

SR-01000939863-2

ST2406732

SW208077-3

Tox21_112630

Tox21_112672

Tox21_112672_1

UNII-69G8BD63PP

Velcade (Millenium)

Velcade (TN)

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

ZINC169746649

Paragraph IV (Patent) Challenges for VELCADE

Tradename	Dosage	Ingredient	NDA	Submissiondate
VELCADE	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	bortezomib	021602	2008-11-20

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					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

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
Millennium Pharms	VELCADE	bortezomib	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	021602-001	May 13, 2003
Millennium Pharms	VELCADE	bortezomib	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	021602-001	May 13, 2003

International Patents for VELCADE

Country	Patent Number	Estimated Expiration
European Patent Office	1355910
European Patent Office	3078667
Spain	2571219
Canada	2435124
Canada	2435146
Spain	2359391
Germany	60239384

Supplementary Protection Certificates for VELCADE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0788360	04C0014	France		PRODUCT NAME: BORTEZOMIB; REGISTRATION NO/DATE: EU/1/04/274/001 20040426
0788360	SPC/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