Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Serving leading biopharmaceutical companies globally:

Dow
Mallinckrodt
McKinsey
Express Scripts
Colorcon
Moodys

Last Updated: November 18, 2019

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Bortezomib - Generic Drug Details

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

Bortezomib is the generic ingredient in two branded drugs marketed by Millennium Pharms, Fresenius Kabi Usa, and Hospira Inc, and is included in three NDAs. There are three patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Bortezomib has twenty-eight patent family members in twelve countries.

There are twenty drug master file entries for bortezomib. Two suppliers are listed for this compound. There are five tentative approvals for this compound.

Drug Prices for bortezomib

See drug prices for bortezomib

Recent Clinical Trials for bortezomib

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

SponsorPhase
GlaxoSmithKlinePhase 3
Janssen PharmaceuticaPhase 2
Jena University HospitalPhase 2

See all bortezomib clinical trials

Recent Litigation for bortezomib

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 bortezomib litigation

Generic filers with tentative approvals for BORTEZOMIB
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial3.5MG/VIALINJECTABLE;INTRAVENOUS, SUBCUTANEOUS
  Start Trial  Start Trial3.5MG/VIALVIAL
  Start Trial  Start Trial3.5MG/VIALINJECTABLE;INJECTION

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for bortezomib
Drug ClassProteasome Inhibitor
Mechanism of ActionProteasome Inhibitors
Medical Subject Heading (MeSH) Categories for bortezomib
Synonyms for bortezomib
((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 (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
Velcade (Millenium)
Velcade (TN)
Velcade, MG-341, PS-341,179324-69-7
ZINC169746649
Paragraph IV (Patent) Challenges for BORTEZOMIB
Tradename Dosage Ingredient NDA Submissiondate
VELCADE INJECTABLE;INTRAVENOUS, SUBCUTANEOUS bortezomib 021602 2008-11-20

US Patents and Regulatory Information for bortezomib

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   Start Trial   Start Trial Y   Start Trial
Fresenius Kabi Usa BORTEZOMIB bortezomib POWDER;INTRAVENOUS 205004-001 Nov 6, 2017 RX No No   Start Trial   Start Trial Y   Start Trial
Millennium Pharms VELCADE bortezomib INJECTABLE;INTRAVENOUS, SUBCUTANEOUS 021602-001 May 13, 2003 RX Yes Yes   Start Trial   Start Trial   Start Trial
>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 bortezomib

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

Supplementary Protection Certificates for bortezomib

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

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Moodys
Mallinckrodt
Express Scripts
Dow
Johnson and Johnson
Medtronic

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.