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Last Updated: March 8, 2021

DrugPatentWatch Database Preview

Bortezomib - Generic Drug Details

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What are the generic 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, Dr Reddys Labs Ltd, Fresenius Kabi Usa, and Hospira Inc, and is included in four 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 thirty-one patent family members in thirteen countries.

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

Drug Prices for bortezomib

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Recent Clinical Trials for bortezomib

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SponsorPhase
Jacob LaubachPhase 2
SanofiPhase 2
Academic and Community Cancer Research UnitedPhase 2

See all bortezomib clinical trials

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
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
Fresenius Kabi Usa BORTEZOMIB bortezomib POWDER;INTRAVENOUS 205004-001 Nov 6, 2017 RX No No   Start Trial   Start Trial Y   Start Trial
Dr Reddys Labs Ltd BORTEZOMIB bortezomib POWDER;INTRAVENOUS 206927-001 Oct 4, 2019 RX No No   Start Trial   Start Trial   Start Trial
Hospira Inc BORTEZOMIB bortezomib POWDER;INTRAVENOUS, SUBCUTANEOUS 209191-002 Dec 28, 2018 DISCN Yes No   Start Trial   Start Trial   Start Trial
Hospira Inc BORTEZOMIB bortezomib POWDER;INTRAVENOUS, SUBCUTANEOUS 209191-001 Jul 12, 2018 DISCN Yes No   Start Trial   Start Trial   Start Trial
Millennium Pharms VELCADE bortezomib INJECTABLE;INTRAVENOUS, SUBCUTANEOUS 021602-001 May 13, 2003 RX Yes Yes   Start Trial   Start Trial Y   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
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

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Serving leading biopharmaceutical companies globally:

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Baxter
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Boehringer Ingelheim

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