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Last Updated: October 14, 2019

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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-four 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.

Drug patent expirations by year for VELCADE
Drug Prices for VELCADE

See drug prices for VELCADE

Recent Clinical Trials for VELCADE

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

SponsorPhase
TakedaPhase 2
Mayo ClinicPhase 1
Leaf Vertical Inc.Phase 1/Phase 2

See all VELCADE clinical trials

Recent Litigation for VELCADE

Identify potential future generic entrants

District Court Litigation
Case NameDate
Millennium Pharmaceuticals, Inc. v. Hetero Labs Limited2018-10-22
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 ClassProteasome Inhibitor
Mechanism of ActionProteasome 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

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

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   See Pricing   See Pricing
Millennium Pharms VELCADE bortezomib INJECTABLE;INTRAVENOUS, SUBCUTANEOUS 021602-001 May 13, 2003   See Pricing   See Pricing
Millennium Pharms VELCADE bortezomib INJECTABLE;INTRAVENOUS, SUBCUTANEOUS 021602-001 May 13, 2003   See Pricing   See Pricing
Millennium Pharms VELCADE bortezomib INJECTABLE;INTRAVENOUS, SUBCUTANEOUS 021602-001 May 13, 2003   See Pricing   See Pricing
Millennium Pharms VELCADE bortezomib INJECTABLE;INTRAVENOUS, SUBCUTANEOUS 021602-001 May 13, 2003   See Pricing   See Pricing
Millennium Pharms VELCADE bortezomib INJECTABLE;INTRAVENOUS, SUBCUTANEOUS 021602-001 May 13, 2003   See Pricing   See Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration
Paragraph IV (Patent) Challenges for VELCADE
Drugname Dosage Strength RLD Date
➤ Subscribe For Injection 3.5 mg/vial ➤ Subscribe   See Pricing

Supplementary Protection Certificates for VELCADE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0788360 04C0014 France   See Pricing PRODUCT NAME: BORTEZOMIB; REGISTRATION NO/DATE: EU/1/04/274/001 20040426
0788360 SPC/GB04/021 United Kingdom   See Pricing 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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