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Serving 500+ biopharmaceutical companies globally:

QuintilesIMS
Johnson and Johnson
Chubb
Colorcon
Merck
Healthtrust
Cantor Fitzgerald
Fish and Richardson
Boehringer Ingelheim
Medtronic

Generated: September 24, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021602

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NDA 021602 describes VELCADE, which 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. Additional details are available on the VELCADE profile page.

The generic ingredient in VELCADE is bortezomib. There are eighteen 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 NDA: 021602

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:3
Formulation / Manufacturing:see details

Pharmacology for NDA: 021602

Mechanism of ActionProteasome Inhibitors

Suppliers and Packaging for NDA: 021602

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VELCADE
bortezomib
INJECTABLE;INTRAVENOUS, SUBCUTANEOUS 021602 NDA Millennium Pharmaceuticals, Inc. 63020-049 63020-049-01 1 VIAL in 1 CARTON (63020-049-01) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (63020-049-04)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUS, SUBCUTANEOUSStrength3.5MG/VIAL
Approval Date:May 13, 2003TE:RLD:Yes
Regulatory Exclusivity Expiration:Oct 8, 2017
Regulatory Exclusivity Use:DOSE MODIFICATION GUIDELINES FOR BORTEZOMIB WHEN GIVEN IN COMBINATION WITH RITUXIMAB, CYCLOPHOSPHAMIDE, DOXORUBICIN, AND PREDNISONE
Regulatory Exclusivity Expiration:Oct 8, 2017
Regulatory Exclusivity Use:DOSING INFORMATION IN PREVIOUSLY UNTREATED MANTLE CELL LYMPHOMA
Regulatory Exclusivity Expiration:Aug 8, 2017
Regulatory Exclusivity Use:INFORMATION ADDED TO THE DOSING AND ADMINISTRATION SECTION OF THE PACKAGE INSERT REGARDING RETREATMENT WITH VELCADE FOR PATIENTS WITH MULTIPLE MYELOMA

Expired Orange Book Patents for NDA: 021602

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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Serving 500+ biopharmaceutical companies globally:

Julphar
Accenture
US Army
Covington
Federal Trade Commission
AstraZeneca
Cipla
Mallinckrodt
Medtronic
Chinese Patent Office

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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