Generic Cerezyme Availability

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

CEREZYME (imiglucerase - injectable;injection)

  • Manufacturer: GENZYME
    Approval date: May 23, 1994
    Strength(s): 200 UNITS/VIAL
  • Manufacturer: GENZYME
    Approval date: September 22, 1999
    Strength(s): 400 UNITS/VIAL [RLD]

Has a generic version of Cerezyme been approved?

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

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Cerezyme. 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.

  • Enhanced in vivo uptake of glucocerebrosidase
    Patent 5,549,892
    Issued: August 27, 1996
    Inventor(s): Friedman; BethAnn & Hayes; Michael
    Assignee(s): Genzyme Corporation
    A pharmaceutical composition comprising remodelled recombinant glucocerebrosidase (GCR) is described that provides a therapeutic effect at doses that are lower then those required using remodelled naturally occurring GCR. A method of treating patients with Gaucher's disease using remodelled recombinant GCR is also provided. In vivo uptake of exogenous molecules can be determined by extracting a mixture of cells from a subject, enriching the target cells in vitro, lysing the cells and determining the amount of exogenous molecules.
    Patent expiration dates:
    • August 27, 2013
      ✓ 
      Patent use: METHOD OF TREATING A HUMAN SUBJECT HAVING GAUCHER'S DISEASE

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.
Hide
(web3)