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Serving leading biopharmaceutical companies globally:

McKinsey
Fuji
Cerilliant
Covington
Express Scripts
Moodys
Mallinckrodt
Johnson and Johnson
Novartis
Chinese Patent Office

Generated: October 20, 2017

DrugPatentWatch Database Preview

Bortezomib - Generic Drug Details

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What are the generic drug sources for bortezomib and what is the scope of bortezomib freedom to operate?

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.

Bortezomib has seventy-five patent family members in twenty-five countries and seven supplementary protection certificates in seven countries.

There are nineteen drug master file entries for bortezomib. One supplier is listed for this compound. There is one tentative approval for this compound.

Summary for Generic Name: bortezomib

US Patents:3
Tradenames:1
Applicants:1
NDAs:1
Drug Master File Entries: see list19
Suppliers / Packagers: see list1
Bulk Api Vendors: see list68
Clinical Trials: see list783
Patent Applications: see list127
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:bortezomib at DailyMed

Pharmacology for Ingredient: bortezomib

Drug ClassProteasome Inhibitor
Mechanism of ActionProteasome Inhibitors

Tentative approvals for BORTEZOMIB

Applicant Application No. Strength Dosage Form
u► Subscribe3.5MGINJECTABLE;INJECTION
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Millennium Pharms
VELCADE
bortezomib
INJECTABLE;INTRAVENOUS, SUBCUTANEOUS021602-001May 13, 2003RXYesYes► Subscribe► Subscribe► Subscribe
Millennium Pharms
VELCADE
bortezomib
INJECTABLE;INTRAVENOUS, SUBCUTANEOUS021602-001May 13, 2003RXYesYes► Subscribe► Subscribe► Subscribe
Millennium Pharms
VELCADE
bortezomib
INJECTABLE;INTRAVENOUS, SUBCUTANEOUS021602-001May 13, 2003RXYesYes► Subscribe► Subscribe► Subscribe
Millennium Pharms
VELCADE
bortezomib
INJECTABLE;INTRAVENOUS, SUBCUTANEOUS021602-001May 13, 2003RXYesYes► Subscribe► SubscribeY► Subscribe
Millennium Pharms
VELCADE
bortezomib
INJECTABLE;INTRAVENOUS, SUBCUTANEOUS021602-001May 13, 2003RXYesYes► Subscribe► Subscribe► Subscribe
Millennium Pharms
VELCADE
bortezomib
INJECTABLE;INTRAVENOUS, SUBCUTANEOUS021602-001May 13, 2003RXYesYes► Subscribe► Subscribe► Subscribe
Millennium Pharms
VELCADE
bortezomib
INJECTABLE;INTRAVENOUS, SUBCUTANEOUS021602-001May 13, 2003RXYesYes► Subscribe► SubscribeY► Subscribe
Millennium Pharms
VELCADE
bortezomib
INJECTABLE;INTRAVENOUS, SUBCUTANEOUS021602-001May 13, 2003RXYesYes► Subscribe► Subscribe► Subscribe
Millennium Pharms
VELCADE
bortezomib
INJECTABLE;INTRAVENOUS, SUBCUTANEOUS021602-001May 13, 2003RXYesYes► Subscribe► Subscribe► Subscribe
Millennium Pharms
VELCADE
bortezomib
INJECTABLE;INTRAVENOUS, SUBCUTANEOUS021602-001May 13, 2003RXYesYes► Subscribe► SubscribeY► 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, 2003► Subscribe► Subscribe
Millennium Pharms
VELCADE
bortezomib
INJECTABLE;INTRAVENOUS, SUBCUTANEOUS021602-001May 13, 2003► Subscribe► Subscribe
Millennium Pharms
VELCADE
bortezomib
INJECTABLE;INTRAVENOUS, SUBCUTANEOUS021602-001May 13, 2003► Subscribe► Subscribe
Millennium Pharms
VELCADE
bortezomib
INJECTABLE;INTRAVENOUS, SUBCUTANEOUS021602-001May 13, 2003► Subscribe► Subscribe
Millennium Pharms
VELCADE
bortezomib
INJECTABLE;INTRAVENOUS, SUBCUTANEOUS021602-001May 13, 2003► Subscribe► 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
7,109,323Formulation of boronic acid compounds► Subscribe
6,066,730 Boronic ester and acid compounds, synthesis and uses► Subscribe
7,119,080Boronic ester and acid compounds, synthesis and uses► Subscribe
7,531,526Boronic ester and acid compounds, synthesis and uses► Subscribe
6,297,217 Boronic ester and acid compounds, synthesis and uses► Subscribe
6,699,835 Formulation of boronic acid compounds► Subscribe
6,465,433 Boronic ester and acid compounds, synthesis and uses► Subscribe
6,617,317 Boronic ester and acid compositions► Subscribe
6,083,903 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
China1168633► Subscribe
Portugal1355910► Subscribe
World Intellectual Property Organization (WIPO)02059131► Subscribe
European Patent Office3078667► Subscribe
Spain2199257► Subscribe
Japan3717934► Subscribe
World Intellectual Property Organization (WIPO)9613266► Subscribe
Chile2004001150► Subscribe
Canada2203936► Subscribe
Austria501157► 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
C0014France► SubscribePRODUCT NAME: BORTEZOMIB; REGISTRATION NO/DATE: EU/1/04/274/001 20040426
083Luxembourg► Subscribe91083, EXPIRES: 20190426
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
C008/2004Ireland► SubscribeSPC008/2004: 20050504, EXPIRES: 20190425
2004 00012Denmark► Subscribe
0151Netherlands► Subscribe300151, 20151027, EXPIRES: 20190425
0788360/01Switzerland► SubscribeFORMER REPRESENTANTIVE: BOVARD AG PATENTANWAELTE, CH
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Dow
US Army
McKesson
QuintilesIMS
Cantor Fitzgerald
Covington
Chinese Patent Office
Express Scripts
Fuji
AstraZeneca

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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