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Bortezomib - Generic Drug Details

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Bortezomib is the generic ingredient in one branded drug marketed by Millennium Pharms and is included in one NDA. There are three patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

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

There are eighteen drug master file entries for bortezomib. One supplier is listed for this compound. There are two tentative approvals for this compound.

Summary for Generic Name: bortezomib

Tradenames:1
Patents:3
Applicants:1
NDAs:1
Drug Master File Entries: see list18
Suppliers / Packagers: see list1
Bulk Api Vendors: see list68
Clinical Trials: see list458
Patent Applications: see list49
Formulation / Manufacturing:see details
Drug Prices:see low prices

Pharmacology for Ingredient: bortezomib

Drug ClassProteasome Inhibitor
Mechanism of ActionProteasome Inhibitors

Tentative approvals for BORTEZOMIB

Applicant Application No. Form Dosage
<disabled><disabled>INJECTABLE;INJECTION3.5MG
<disabled><disabled>INJECTABLE;INJECTION2.5MG/ML
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, 2003RXYes► subscribe► subscribe
Millennium Pharms
VELCADE
bortezomib
INJECTABLE;INTRAVENOUS, SUBCUTANEOUS021602-001May 13, 2003RXYes6,958,319*PED► subscribeY► subscribe
Millennium Pharms
VELCADE
bortezomib
INJECTABLE;INTRAVENOUS, SUBCUTANEOUS021602-001May 13, 2003RXYes► subscribe► subscribe
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Expired Orange Book Patents for Generic Ingredient: bortezomib

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, 20036,747,150► subscribe
Millennium Pharms
VELCADE
bortezomib
INJECTABLE;INTRAVENOUS, SUBCUTANEOUS021602-001May 13, 20036,297,217► subscribe
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Non-Orange Book Patents for Generic Ingredient: bortezomib

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
6,548,668 Boronic ester and acid compounds, synthesis and uses► subscribe
8,378,099Boronic ester and acid compounds, synthesis and uses► subscribe
6,066,730 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 Ingredient: bortezomib

Country Document Number Estimated Expiration
Netherlands300151► subscribe
Canada2435124► subscribe
Japan3717934► 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: BORTEZOMIB

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C008/2004Ireland► subscribeSPC008/2004: 20050504, EXPIRES: 20190425
2004 00012Denmark► subscribe
C/GB04/021United Kingdom► subscribePRODUCT 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
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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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