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Last Updated: May 19, 2022

VELCADE Drug Patent Profile


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When do Velcade patents expire, and when can generic versions of Velcade launch?

Velcade is a drug marketed by Takeda Pharms Usa 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.

DrugPatentWatch® Litigation and Generic Entry Outlook for Velcade

A generic version of VELCADE was approved as bortezomib by FRESENIUS KABI USA on November 6th, 2017.

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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
Medical College of WisconsinPhase 2
Abdullah KhanPhase 1

See all VELCADE clinical trials

Pharmacology for VELCADE
Drug ClassProteasome Inhibitor
Mechanism of Action Proteasome Inhibitors
Paragraph IV (Patent) Challenges for VELCADE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
VELCADE For Injection bortezomib 3.5 mg/vial 021602 1 2008-11-20

US Patents and Regulatory Information for VELCADE

VELCADE is protected by two US patents and one FDA Regulatory Exclusivity.

Patents protecting VELCADE

Formulation of boronic acid compounds
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Formulation of boronic acid compounds
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

FDA Regulatory Exclusivity protecting VELCADE

PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Takeda Pharms Usa VELCADE bortezomib INJECTABLE;INTRAVENOUS, SUBCUTANEOUS 021602-001 May 13, 2003 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Takeda Pharms Usa VELCADE bortezomib INJECTABLE;INTRAVENOUS, SUBCUTANEOUS 021602-001 May 13, 2003 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and 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
Takeda Pharms Usa VELCADE bortezomib INJECTABLE;INTRAVENOUS, SUBCUTANEOUS 021602-001 May 13, 2003 See Plans and Pricing See Plans and Pricing
Takeda Pharms Usa VELCADE bortezomib INJECTABLE;INTRAVENOUS, SUBCUTANEOUS 021602-001 May 13, 2003 See Plans and Pricing See Plans and Pricing
Takeda Pharms Usa VELCADE bortezomib INJECTABLE;INTRAVENOUS, SUBCUTANEOUS 021602-001 May 13, 2003 See Plans and Pricing See Plans and Pricing
>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 CA 2004 00012 Denmark See Plans and Pricing
0788360 SPC008/2004 Ireland See Plans and Pricing SPC008/2004: 20050504, EXPIRES: 20190425
0788360 300151 Netherlands See Plans and Pricing 300151, 20151027, EXPIRES: 20190425
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Dow
Harvard Business School
McKinsey
Merck
Moodys

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