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Generic Mayzent Availability

Last updated on Aug 11, 2021.

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

MAYZENT (siponimod fumaric acid - tablet;oral)

  • Manufacturer: NOVARTIS
    Approval date: March 26, 2019
    Strength(s): EQ 0.25MG BASE [RLD], EQ 2MG BASE [RLD]

Has a generic version of Mayzent been approved?

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

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

  • Immunosuppresant compounds and compositions
    Patent 7,939,519
    Issued: May 10, 2011
    Inventor(s): Pan; Shifeng & Gao; Wenqi & Gray; Nathanael S & Mi; Yuan & Fan; Yi
    Assignee(s): Novartis AG

    The present invention relates to immunosuppressant, process for their production, their uses and pharmaceutical compositions containing them. The invention provides a novel class of compounds useful in the treatment or prevention of diseases or disorders mediated by lymphocyte interactions, particularly diseases associated with EDG receptor mediated signal transduction.

    Patent expiration dates:

    • May 19, 2024
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      Drug substance
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      Drug product
  • Dosage regimen of an S1P receptor agonist
    Patent 8,492,441
    Issued: July 23, 2013
    Assignee(s): Novartis AG

    S1P receptor modulators or agonists are administered following a dosage regimen whereby during the initial days of treatment the daily dosage is lower than the standard daily dosage.

    Patent expiration dates:

    • November 30, 2030
      ✓ 
      Patent use: A METHOD OF TREATING MULTIPLE SCLEROSIS BY ADMINISTERING SIPONIMOD USING A TITRATION SCHEME TO REACH A MAINTENANCE DOSE

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:

    • March 26, 2024 - NEW CHEMICAL ENTITY

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.

Further information

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