Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

Get the Book: Make Better Decisions

Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

PDF eBook: Just $10 Get Print Book on Amazon

Serving leading biopharmaceutical companies globally:

Colorcon
AstraZeneca
Dow
Baxter
Moodys
McKesson

Last Updated: December 7, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021602

See Plans and Pricing

« Back to Dashboard

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 two 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 twenty drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the bortezomib profile page.
Summary for 021602
Tradename:VELCADE
Applicant:Millennium Pharms
Ingredient:bortezomib
Patents:2
Formulation / Manufacturing:see details
Pharmacology for NDA: 021602
Mechanism of ActionProteasome Inhibitors
Medical Subject Heading (MeSH) Categories for 021602
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)
Paragraph IV (Patent) Challenges for 021602
Tradename Dosage Ingredient NDA Submissiondate
VELCADE INJECTABLE;INTRAVENOUS, SUBCUTANEOUS bortezomib 021602 2008-11-20

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUS, SUBCUTANEOUSStrength3.5MG/VIAL
Approval Date:May 13, 2003TE:RLD:Yes
Regulatory Exclusivity Expiration:Apr 8, 2022
Regulatory Exclusivity Use:PEDIATRIC EXCLUSIVITY
Regulatory Exclusivity Expiration:Mar 14, 2019
Regulatory Exclusivity Use:PEDIATRIC EXCLUSIVITY
Regulatory Exclusivity Expiration:Oct 8, 2021
Regulatory Exclusivity Use:TREATMENT OF PATIENTS WITH MANTLE CELL LYMPHOMA WHO HAVE NOT RECEIVED AT LEAST 1 PRIOR THERAPY

Expired US Patents for NDA 021602

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Millennium Pharms VELCADE bortezomib INJECTABLE;INTRAVENOUS, SUBCUTANEOUS 021602-001 May 13, 2003   Start Trial   Start Trial
Millennium Pharms VELCADE bortezomib INJECTABLE;INTRAVENOUS, SUBCUTANEOUS 021602-001 May 13, 2003   Start Trial   Start Trial
Millennium Pharms VELCADE bortezomib INJECTABLE;INTRAVENOUS, SUBCUTANEOUS 021602-001 May 13, 2003   Start Trial   Start Trial
Millennium Pharms VELCADE bortezomib INJECTABLE;INTRAVENOUS, SUBCUTANEOUS 021602-001 May 13, 2003   Start Trial   Start Trial
Millennium Pharms VELCADE bortezomib INJECTABLE;INTRAVENOUS, SUBCUTANEOUS 021602-001 May 13, 2003   Start Trial   Start Trial
Millennium Pharms VELCADE bortezomib INJECTABLE;INTRAVENOUS, SUBCUTANEOUS 021602-001 May 13, 2003   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Express Scripts
Medtronic
Johnson and Johnson
McKesson
Baxter
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.