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VELCADE Drug Profile

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Velcade is a drug marketed by Millennium Pharms and is included in one NDA. It is available from one supplier. There are three patents protecting this drug and one Paragraph IV challenge.

This drug has sixty-three patent family members in twenty-five countries.

The generic ingredient in VELCADE is bortezomib. There are seventeen drug master file entries for this compound. One supplier is listed for this compound. There is one tentative approval for this compound. Additional details are available on the bortezomib profile page.

Summary for Tradename: VELCADE

Patents:3
Applicants:1
NDAs:1
Suppliers / Packagers: see list1

Pharmacology for Tradename: VELCADE

Drug ClassProteasome Inhibitor
Mechanism of ActionProteasome Inhibitors

Clinical Trials for: VELCADE

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Millennium Pharms
VELCADE
bortezomib
INJECTABLE;INTRAVENOUS, SUBCUTANEOUS021602-001May 13, 2003RXYes6,958,319*PED<disabled>Y<disabled>
Millennium Pharms
VELCADE
bortezomib
INJECTABLE;INTRAVENOUS, SUBCUTANEOUS021602-001May 13, 2003RXYes<disabled><disabled>
Millennium Pharms
VELCADE
bortezomib
INJECTABLE;INTRAVENOUS, SUBCUTANEOUS021602-001May 13, 2003RXYes<disabled><disabled>
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Expired Patents for Tradename: VELCADE

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Millennium Pharms
VELCADE
bortezomib
INJECTABLE;INTRAVENOUS, SUBCUTANEOUS021602-001May 13, 20036,083,903<disabled>
Millennium Pharms
VELCADE
bortezomib
INJECTABLE;INTRAVENOUS, SUBCUTANEOUS021602-001May 13, 20036,617,317<disabled>
Millennium Pharms
VELCADE
bortezomib
INJECTABLE;INTRAVENOUS, SUBCUTANEOUS021602-001May 13, 20036,747,150<disabled>
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Paragraph IV activity for: VELCADE

Drugname Dosage Strength RLD Submissiondate
bortezomibFor Injection3.5 mg/vialVelcade11/20/2008

Non-Orange Book Patents for Tradename: VELCADE

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
6,617,317 Boronic ester and acid compositions<disabled in preview>
7,109,323Formulation of boronic acid compounds<disabled in preview>
8,378,099Boronic ester and acid compounds, synthesis and uses<disabled in preview>
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International Patent Family for Tradename: VELCADE

Country Document Number Estimated Expiration
Australia710564<disabled in preview>
Canada2203936<disabled in preview>
Austria314378<disabled in preview>
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Supplementary Protection Certificates for Tradename: VELCADE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C008/2004Ireland<disabled>SPC008/2004: 20050504, EXPIRES: 20190425
C0014France<disabled>PRODUCT NAME: BORTEZOMIB; REGISTRATION NO/DATE: EU/1/04/274/001 20040426
0151Netherlands<disabled>300151, 20151027, EXPIRES: 20190425
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