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Generic Velcade Availability

Last updated on Sep 8, 2022.

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

VELCADE (bortezomib - injectable;intravenous, subcutaneous)

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

Has a generic version of Velcade been approved?

A generic version of Velcade has been approved by the FDA. However, this does not mean that the product will necessarily be commercially available - possibly because of drug patents and/or drug exclusivity. The following products are equivalent to Velcade and have been approved by the FDA:

bortezomib injectable;intravenous, subcutaneous

  • Manufacturer: ACCORD HLTHCARE
    Approval date: July 26, 2022
    Strength(s): 3.5MG/VIAL [AP]
  • Manufacturer: APOTEX
    Approval date: May 2, 2022
    Strength(s): 3.5MG/VIAL [AP]
  • Manufacturer: BAXTER HLTHCARE CORP
    Approval date: May 2, 2022
    Strength(s): 3.5MG/VIAL [AP]
  • Manufacturer: DR REDDYS
    Approval date: July 26, 2022
    Strength(s): 3.5MG/VIAL [AP]
  • Manufacturer: EUGIA PHARMA
    Approval date: May 2, 2022
    Strength(s): 3.5MG/VIAL [AP]
  • Manufacturer: FRESENIUS KABI USA
    Approval date: May 2, 2022
    Strength(s): 3.5MG/VIAL [AP]
  • Manufacturer: HOSPIRA
    Approval date: July 26, 2022
    Strength(s): 3.5MG/VIAL [AP]
  • Manufacturer: JIANGSU HANSOH PHARM
    Approval date: July 26, 2022
    Strength(s): 3.5MG/VIAL [AP]
  • Manufacturer: KINDOS
    Approval date: July 26, 2022
    Strength(s): 3.5MG/VIAL [AP]
  • Manufacturer: MSN
    Approval date: July 26, 2022
    Strength(s): 3.5MG/VIAL [AP]
  • Manufacturer: PHARMASCIENCE INC
    Approval date: May 2, 2022
    Strength(s): 3.5MG/VIAL [AP]
  • Manufacturer: QILU PHARM HAINAN
    Approval date: May 2, 2022
    Strength(s): 3.5MG/VIAL [AP]
  • Manufacturer: SANDOZ INC
    Approval date: July 26, 2022
    Strength(s): 3.5MG/VIAL [AP]
  • Manufacturer: TEVA PHARMS USA
    Approval date: May 2, 2022
    Strength(s): 3.5MG/VIAL [AP]
  • Manufacturer: ZYDUS PHARMS
    Approval date: May 2, 2022
    Strength(s): 3.5MG/VIAL [AP]

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: Generic Drug FAQ.

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.

  • 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
      ✓ 
      Drug substance
      ✓ 
      Drug product
    • July 25, 2022
      ✓ 
      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
      ✓ 
      Drug substance
      ✓ 
      Drug product
    • July 25, 2022
      ✓ 
      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:

    • April 8, 2022 - PEDIATRIC EXCLUSIVITY

Glossary

Term Definition
Drug Patent A 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 Exclusivity Exclusivity 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.
RLD A 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.
AP Injectable aqueous solutions and, in certain instances, intravenous non-aqueous solutions. It should be noted that even though injectable (parenteral) products under a specific listing may be evaluated as therapeutically equivalent, there may be important differences among the products in the general category, Injectable; Injection. For example, some injectable products that are rated therapeutically equivalent are labeled for different routes of administration. In addition, some products evaluated as therapeutically equivalent may have different preservatives or no preservatives at all. Injectable products available as dry powders for reconstitution, concentrated sterile solutions for dilution, or sterile solutions ready for injection are pharmaceutical alternative drug products. They are not rated as therapeutically equivalent (AP) to each other even if these pharmaceutical alternative drug products are designed to produce the same concentration prior to injection and are similarly labeled. Consistent with accepted professional practice, it is the responsibility of the prescriber, dispenser, or individual administering the product to be familiar with a product's labeling to assure that it is given only by the route(s) of administration stated in the labeling.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.