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Generic Velcade Availability

Velcade is a brand name of bortezomib, approved by the FDA in the following formulation(s):

VELCADE (bortezomib - injectable;intravenous, subcutaneous)

  • Manufacturer: MILLENNIUM PHARMS
    Approval date: May 13, 2003
    Strength(s): 3.5MG/VIAL [RLD]

Has a generic version of Velcade been approved?

No. There is currently no therapeutically equivalent version of Velcade available in the United States.

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Velcade. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.

See also: About generic drugs.

Related Patents

Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.

  • Boronic ester and acid compounds
    Patent 5,780,454
    Issued: July 14, 1998
    Inventor(s): Adams; Julian & Ma; Yu-Ting & Stein; Ross & Baevsky; Matthew & Grenier; Louis & Plamondon; Louis
    Assignee(s): ProScript, Inc.
    Disclosed herein is a method for reducing the rate of degradation of proteins in an animal comprising contacting cells of the animal with certain boronic ester and acid compounds. Also disclosed herein are novel boronic ester and acid compounds, their synthesis and uses.
    Patent expiration dates:
    • May 3, 2017
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      Drug substance
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      Drug product
    • November 3, 2017
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      Pediatric exclusivity
  • Formulation of boronic acid compounds
    Patent 6,713,446
    Issued: March 30, 2004
    Inventor(s): Shanker Lal; Gupta
    Assignee(s): The United States of America as represented by the Secretary of the Department of Health and Human Services
    The present invention provides stable compounds prepared from boronic acid and lyophilized compounds thereof of the formula (1): in which Z1 and Z2 are moieties derived from sugar. The invention also provides methods for preparing such compounds. Lyophilizing a mixture comprising a boronic acid compound and a moiety derived from sugar produces a stable composition that readily releases the boronic acid compound upon reconstitution in aqueous media.
    Patent expiration dates:
    • January 25, 2022
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      Drug substance
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      Drug product
    • July 25, 2022
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      Pediatric exclusivity
  • Formulation of boronic acid compounds
    Patent 6,958,319
    Issued: October 25, 2005
    Inventor(s): Gupta; Shanker Lal
    Assignee(s): The United States of America as represented by the Department of Health and Human Services
    The present invention provides stable compounds prepared from boronic acid and lyophilized compounds thereof of the formula (1): in which Z1 and Z2 are moieties derived from sugar. The invention also provides methods for preparing such compounds. Lyophilizing a mixture comprising a boronic acid compound and a moiety derived from sugar produces a stable composition that readily releases the boronic acid compound upon reconstitution in aqueous media.
    Patent expiration dates:
    • January 25, 2022
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      Drug substance
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      Drug product
    • July 25, 2022
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      Pediatric exclusivity

Related Exclusivities

Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.

  • Exclusivity expiration dates:
    • August 8, 2017 - INFORMATION ADDED TO THE DOSING AND ADMINISTRATION SECTION OF THE PACKAGE INSERT REGARDING RETREATMENT WITH VELCADE FOR PATIENTS WITH MULTIPLE MYELOMA
    • October 8, 2017 - DOSING INFORMATION IN PREVIOUSLY UNTREATED MANTLE CELL LYMPHOMA
    • October 8, 2017 - REVISED INDICATION FOR BORTEZOMIB IN THE TREATMENT OF PATIENTS WITH MANTLE CELL LYMPHOMA
    • October 8, 2017 - DOSE MODIFICATION GUIDELINES FOR BORTEZOMIB WHEN GIVEN IN COMBINATION WITH RITUXIMAB, CYCLOPHOSPHAMIDE, DOXORUBICIN, AND PREDNISONE
    • February 8, 2018 -
    • April 8, 2018 -
    • September 14, 2018 - PROVIDES FOR UPDATES TO THE PEDIATRIC USE SECTION BASED ON THE PEDIATRIC STUDY REPORT ENTITLED, 'A PHASE II PILOT TRIAL OF BORTEZOMIB IN COMBINATION WITH INTENSIVE RE-INDUCTION THERAPY IN CHILDREN WITH RELAPSED ACUTE LYMPHOBLASTIC LYMPHOMA (LL)'
    • March 14, 2019 -
    • October 8, 2021 -
    • April 8, 2022 -

Glossary

TermDefinition
Drug PatentA drug patent is assigned by the U.S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation.
Drug ExclusivityExclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant.
RLDA Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart.
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