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Generic Cerdelga Availability

Last updated on Sep 8, 2021.

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

CERDELGA (eliglustat tartrate - capsule;oral)

  • Manufacturer: GENZYME CORP
    Approval date: August 19, 2014
    Strength(s): EQ 84MG BASE [RLD] [AB]

Has a generic version of Cerdelga been approved?

A generic version of Cerdelga 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 Cerdelga and have been approved by the FDA:

eliglustat tartrate capsule;oral

  • Manufacturer: AIZANT
    Approval date: September 8, 2021
    Strength(s): EQ 84MG BASE [AB]

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

  • Patent 10,888,544

    Patent expiration dates:

    • December 13, 2038
      ✓ 
      Patent use: LONG-TERM TREATMENT OF ADULTS WITH GAUCHER DISEASE TYPE 1 WHO ARE CYP2D6 EXTENSIVE METABOLIZERS WITH MODERATE TO SEVERE RENAL IMPAIRMENT
    • December 13, 2038
      ✓ 
      Patent use: LONG-TERM TREATMENT OF ADULTS WITH GAUCHER DISEASE TYPE 1 WHO ARE CYP2D6 EXTENSIVE METABOLIZERS WITH MILD HEPATIC IMPAIRMENT AND ARE CONCURRENTLY TAKING A STRONG OR MODERATE CYP3A INHIBITOR
  • Patent 10,888,547

    Patent expiration dates:

    • January 31, 2031
      ✓ 
      Patent use: LONG-TERM TREATMENT OF ADULTS WITH GAUCHER DISEASE TYPE 1 WHO ARE CYP2D6 POOR METABOLIZERS WITH 84 MG ONCE DAILY OF ELIGLUSTAT (EQUIVALENT TO 100 MG OF ELIGLUSTAT TARTRATE)
    • January 31, 2031
      ✓ 
      Patent use: LONG-TERM TREATMENT OF ADULTS WITH GAUCHER DISEASE TYPE 1 WHO ARE CYP2D6 EXTENSIVE OR INTERMEDIATE METABOLIZERS WITH 84 MG TWICE PER DAY OF ELIGLUSTAT (EQUIVALENT TO 100 MG OF ELIGLUSTAT TARTRATE TWICE PER DAY)
  • Amino ceramide-like compounds and therapeutic methods of use
    Patent 6,916,802
    Issued: July 12, 2005
    Inventor(s): Shayman; James A. & Harris; David J. & Siegel; Craig & Nelson; Carol A. & Copeland; Diane P.
    Assignee(s): Genzyme Corporation The Regents of the University of Michigan

    The present invention provides amino ceramide-like compounds which inhibit glucosyl ceramide (GlyCer) formation by inhibiting the enzyme GlyCer synthase, thereby lowering the level of glycosphingolipids. The compounds of the present invention have improved GlcCer synthase inhibition activity and are therefore useful in therapeutic methods for treating various conditions and diseases associated with altered glycosphingolipid levels.

    Patent expiration dates:

    • April 29, 2022
      ✓ 
      Patent use: TREATMENT OF GAUCHER DISEASE TYPE 1
      ✓ 
      Drug substance
  • Synthesis of UDP-glucose: N-acylsphingosine glucosyltransferase inhibitors
    Patent 7,196,205
    Issued: March 27, 2007
    Inventor(s): Siegel; Craig & Shayman; James A. & Nelson; Carol A. & Harris; David J. & Copeland; Diane P.
    Assignee(s): The Regents of the University of Michigan Genzyme Corporation

    Disclosed is a novel enantiomeric synthesis ceramide-like inhibitors of UDP-glucose: N-acylsphingosine glucosyltransferase. Also disclosed are novel intermediates formed during the synthesis.

    Patent expiration dates:

    • June 26, 2026
      ✓ 
      Drug substance
  • Amino ceramide-like compounds and therapeutic methods of use
    Patent 7,253,185
    Issued: August 7, 2007
    Inventor(s): Shayman; James A. & Harris; David J. & Siegel; Craig & Nelson; Carol A. & Copeland; Diane P.
    Assignee(s): The Regents of the University of Michigan Genzyme Corporation

    The present invention provides amino ceramide-like compounds which inhibit glucosyl ceramide (GlyCer) formation by inhibiting the enzyme GlyCer synthase, thereby lowering the level of glycosphingolipids. The compounds of the present invention have improved GlcCer synthase inhibition activity and are therefore useful in therapeutic methods for treating various conditions and diseases associated with altered glycosphingolipid levels.

    Patent expiration dates:

    • April 29, 2022
      ✓ 
      Drug product
  • Synthesis of UDP-glucose: N-acylsphingosine glucosyltransferase inhibitors
    Patent 7,615,573
    Issued: November 10, 2009
    Inventor(s): Siegel; Craig & Shayman; James A. & Nelson; Carol A. & Harris; David J. & Copeland; Diane P.
    Assignee(s): The Regents of the University of Michigan Genzyme Corporation

    Disclosed is a novel enantiomeric synthesis ceramide-like inhibitors of UDP-glucose: N-acylsphingosine glucosyltransferase. Also disclosed are novel intermediates formed during the synthesis.

    Patent expiration dates:

    • April 29, 2022
      ✓ 
      Patent use: TREATMENT OF GAUCHER DISEASE TYPE 1

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 19, 2021 - LONG-TERM TREATMENT OF ADULT PATIENTS WITH GAUCHER DISEASE TYPE 1 WHO ARE CYP2D6 EXTENSIVE METABOLIZERS (EMS), INTERMEDIATE METABOLIZERS (IMS), OR POOR METABOLIZERS (PMS) AS DETECTED BY AN FDA-CLEARED TEST.

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.
AB Products meeting necessary bioequivalence requirements. Multisource drug products listed under the same heading (e.g. identical active ingredients, dosage form, and routes of administration) and having the same strength (see Therapeutic Equivalence-Related Terms, Pharmaceutical Equivalents) generally will be coded AB if a study is submitted demonstrating bioequivalence. In certain instances, a number is added to the end of the AB code to make a three character code (e.g. AB1, AB2, AB7). Three-character codes are assigned only in situations when more than one reference listed drug of the same strength has been designated under the same heading. Two or more reference listed drugs are generally selected only when there are at least two potential reference drug products which are not bioequivalent to each other. If a study is submitted that demonstrates bioequivalence to a specific listed drug product, the generic product will be given the same three-character code as the reference listed drug it was compared against.

Further information

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