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Last Updated: October 16, 2021

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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 Takeda Pharms Usa, Dr Reddys Labs Ltd, and Fresenius Kabi Usa, 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 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 twelve 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
Tufts Medical CenterPhase 2
Tianjin Medical University Cancer Institute and HospitalPhase 4
Second Hospital of Shanxi Medical UniversityPhase 4

See all bortezomib clinical trials

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

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
Takeda Pharms Usa VELCADE bortezomib INJECTABLE;INTRAVENOUS, SUBCUTANEOUS 021602-001 May 13, 2003 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Takeda Pharms Usa VELCADE bortezomib INJECTABLE;INTRAVENOUS, SUBCUTANEOUS 021602-001 May 13, 2003 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever Trial
Dr Reddys Labs Ltd BORTEZOMIB bortezomib POWDER;INTRAVENOUS 206927-001 Oct 4, 2019 RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Takeda Pharms Usa VELCADE bortezomib INJECTABLE;INTRAVENOUS, SUBCUTANEOUS 021602-001 May 13, 2003 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Takeda Pharms Usa VELCADE bortezomib INJECTABLE;INTRAVENOUS, SUBCUTANEOUS 021602-001 May 13, 2003 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever 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
Takeda Pharms Usa VELCADE bortezomib INJECTABLE;INTRAVENOUS, SUBCUTANEOUS 021602-001 May 13, 2003 ⤷  Free Forever Trial ⤷  Free Forever Trial
Takeda Pharms Usa VELCADE bortezomib INJECTABLE;INTRAVENOUS, SUBCUTANEOUS 021602-001 May 13, 2003 ⤷  Free Forever Trial ⤷  Free Forever Trial
Takeda Pharms Usa VELCADE bortezomib INJECTABLE;INTRAVENOUS, SUBCUTANEOUS 021602-001 May 13, 2003 ⤷  Free Forever Trial ⤷  Free Forever Trial
Takeda Pharms Usa VELCADE bortezomib INJECTABLE;INTRAVENOUS, SUBCUTANEOUS 021602-001 May 13, 2003 ⤷  Free Forever Trial ⤷  Free Forever Trial
Takeda Pharms Usa VELCADE bortezomib INJECTABLE;INTRAVENOUS, SUBCUTANEOUS 021602-001 May 13, 2003 ⤷  Free Forever Trial ⤷  Free Forever 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 SPC/GB04/021 United Kingdom ⤷  Free Forever 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
0788360 04C0014 France ⤷  Free Forever Trial PRODUCT NAME: BORTEZOMIB; REGISTRATION NO/DATE: EU/1/04/274/001 20040426
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Express Scripts
AstraZeneca
Harvard Business School
Moodys
Dow
Medtronic

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