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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-five patent family members in twenty-five countries.

The generic ingredient in VELCADE is bortezomib. There are eighteen drug master file entries for this compound. One supplier is listed for this compound. There are two tentative approvals 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
Bulk Api Vendors: see list67
Clinical Trials: see list342
Patent Applications: see list76
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:VELCADE at DailyMed

Pharmacology for Tradename: VELCADE

Drug ClassProteasome Inhibitor
Mechanism of ActionProteasome Inhibitors
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Millennium Pharms
VELCADE
bortezomib
INJECTABLE;INTRAVENOUS, SUBCUTANEOUS021602-001May 13, 2003RXYesYes5,780,454*PED► subscribeY► subscribe
Millennium Pharms
VELCADE
bortezomib
INJECTABLE;INTRAVENOUS, SUBCUTANEOUS021602-001May 13, 2003RXYesYes► subscribe► subscribe
Millennium Pharms
VELCADE
bortezomib
INJECTABLE;INTRAVENOUS, SUBCUTANEOUS021602-001May 13, 2003RXYesYes► subscribe► subscribe
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Expired Patents for Tradename: VELCADE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Millennium Pharms
VELCADE
bortezomib
INJECTABLE;INTRAVENOUS, SUBCUTANEOUS021602-001May 13, 20036,083,903► subscribe
Millennium Pharms
VELCADE
bortezomib
INJECTABLE;INTRAVENOUS, SUBCUTANEOUS021602-001May 13, 20036,297,217► subscribe
Millennium Pharms
VELCADE
bortezomib
INJECTABLE;INTRAVENOUS, SUBCUTANEOUS021602-001May 13, 20037,119,080► subscribe
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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
7,119,080Boronic ester and acid compounds, synthesis and uses► subscribe
6,066,730 Boronic ester and acid compounds, synthesis and uses► subscribe
6,465,433 Boronic ester and acid compounds, synthesis and uses► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Tradename: VELCADE

Country Document Number Estimated Expiration
Hong Kong1002059► subscribe
China101077875► subscribe
Taiwan318850► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: VELCADE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0788360/01Switzerland► subscribeFORMER REPRESENTANTIVE: BOVARD AG PATENTANWAELTE, CH
0151Netherlands► subscribe300151, 20151027, EXPIRES: 20190425
C0014France► subscribePRODUCT NAME: BORTEZOMIB; REGISTRATION NO/DATE: EU/1/04/274/001 20040426
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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