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Last Updated: January 19, 2021

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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-seven patent family members in thirteen countries.

The generic ingredient in VELCADE is bortezomib. There are twenty drug master file entries for this compound. Three 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 approved as bortezomib by FRESENIUS KABI USA on November 6th, 2017.

  Start Trial

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
Academic and Community Cancer Research UnitedPhase 2
Karyopharm Therapeutics IncPhase 2
Medical College of WisconsinPhase 2

See all VELCADE clinical trials

Pharmacology for VELCADE
Drug ClassProteasome Inhibitor
Mechanism of ActionProteasome Inhibitors
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   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
Millennium Pharms VELCADE bortezomib INJECTABLE;INTRAVENOUS, SUBCUTANEOUS 021602-001 May 13, 2003 RX Yes Yes   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 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   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 VELCADE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
0788360 300151 Netherlands   Start Trial 300151, 20151027, EXPIRES: 20190425
0788360 C00788360/01 Switzerland   Start Trial FORMER REPRESENTANTIVE: BOVARD AG PATENTANWAELTE, CH
0788360 SPC008/2004 Ireland   Start Trial SPC008/2004: 20050504, EXPIRES: 20190425
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Mallinckrodt
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Harvard Business School
McKinsey
Merck
Moodys

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