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Profile for Tradename: VELCADE

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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 eight patents protecting this drug and one Paragraph IV challenge.

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

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

Summary for Tradename: VELCADE

Patents:8
Applicants:1
NDAs:1
Suppliers / Packagers: see list1
2013 Sales:$621,800,000

Pharmacology for Tradename: VELCADE

Drug ClassProteasome Inhibitor
Mechanism of ActionProteasome Inhibitors

Clinical Trials for: VELCADE

Addition of Daratumumab to Combination of Bortezomib and Dexamethasone in Participants With Relapsed or Refractory Multiple Myeloma
Status: Recruiting Condition: Multiple Myeloma

Study of DOXIL/CAELYX (Pegylated Liposomal Doxorubicin) and VELCADE (Bortezomib) or VELCADE Monotherapy for the Treatment of Relapsed Multiple Myeloma
Status: Completed Condition: Multiple Myeloma

Study on the Safety and Effectiveness of VELCADE® in the Treatment of Graft-Versus-Host Disease
Status: Completed Condition: Graft-versus-Host Disease

An Open-Label Study to Assess the Effect of CYP3A4 Induction on the Pharmacokinetics of VELCADE (Bortezomib)
Status: Completed Condition: Multiple Myeloma; Non-Hodgkin's Lymphoma

A Dose Escalation Study of the Histone Deacetylase Inhibitor (HDACi) JNJ 26481585 in Combination With VELCADE (Bortezomib) and Dexamethasone for Patients With Relapsed Multiple Myeloma
Status: Completed Condition: Multiple Myeloma

Velcade and Sorafenib in Unresected or Metastatic Renal Cell Carcinoma
Status: Active, not recruiting Condition: Metastatic Renal Cell Carcinoma

Bortezomib (Velcade) in Patients With Untreated Multiple Myeloma
Status: Active, not recruiting Condition: Multiple Myeloma

Velcade, Melphalan, Prednisone And Thalidomide Versus Velcade, Melphalan, Prednisone in Multiple Myeloma Patients
Status: Active, not recruiting Condition: Multiple Myeloma

Pilot Study of Velcade® in IgA Nephropathy
Status: Recruiting Condition: Chronic Kidney Disease; IgA Nephropathy

A Study to Compare CNTO 328 (Anti-IL-6 Monoclonal Antibody) and VELCADE-Melphalan-Prednisone (VMP) With VMP Alone in Previously Untreated Multiple Myeloma Patients
Status: Completed Condition: Multiple Myeloma

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
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, 2003RXYes6,083,903<disabled>Y<disabled>
Millennium Pharms
VELCADE
bortezomib
INJECTABLE;INTRAVENOUS, SUBCUTANEOUS021602-001May 13, 2003RXYes5,780,454<disabled>YY<disabled>
Millennium Pharms
VELCADE
bortezomib
INJECTABLE;INTRAVENOUS, SUBCUTANEOUS021602-001May 13, 2003RXYes<disabled><disabled>
Millennium Pharms
VELCADE
bortezomib
INJECTABLE;INTRAVENOUS, SUBCUTANEOUS021602-001May 13, 2003RXYes6,958,319<disabled>YY<disabled>
Millennium Pharms
VELCADE
bortezomib
INJECTABLE;INTRAVENOUS, SUBCUTANEOUS021602-001May 13, 2003RXYes<disabled><disabled>
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Paragraph IV activity for: VELCADE

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

International Patent Family for Tradename: VELCADE

Country Document Number Publication Date
Israel133831Apr 30, 2001
China101077875Jan 26, 2011
South Africa9509119May 27, 1996
Chile2004001150Apr 08, 2005
Spain2359391May 23, 2011
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Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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