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Generic Mavenclad Availability

Last updated on Sep 8, 2021.

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

MAVENCLAD (cladribine - tablet;oral)

  • Manufacturer: EMD SERONO INC
    Approval date: March 29, 2019
    Strength(s): 10MG [RLD]

Has a generic version of Mavenclad been approved?

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

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

  • Cladribine regimen for treating multiple sclerosis
    Patent 7,713,947
    Issued: May 11, 2010
    Inventor(s): De Luca; Giampiero & Ythier; Arnaud & Munafo; Alain & Lopez-Bresnahan; Maria
    Assignee(s): Merck Serono S.A.

    The present invention is related to the use of Cladribine for the preparation of a pharmaceutical formulation for the treatment of multiple sclerosis, especially relapsing-remitting multiple sclerosis or early secondary progressive multiple sclerosis, wherein the preparation is to be orally administered and wherein re-treatments are possible.

    Patent expiration dates:

    • October 16, 2026
      ✓ 
      Patent use: TREATING MS WITH ORAL CLADRIBINE ACC. TO THE STEPS (I) INDUCTION PERIOD WITH ABOUT 1.7 MG/KG-3.5 MG/KG CLADRIBINE; (II) CLADRIBINE-FREE PERIOD OF ABOUT 8-10 MONTHS; (III) MAINTENANCE PERIOD WITH ABOUT 1.7 MG/KG CLADRIBINE; (IV) CLADRIBINE-FREE PERIOD
  • Oral formulations of cladribine
    Patent 7,888,328
    Issued: February 15, 2011
    Inventor(s): Bodor; Nicholas S. & Dandiker; Yogesh
    Assignee(s): Ares Trading S.A.

    Provided are compositions of cladribine and cyclodextrin which are especially suited for the oral administration of cladribine.

    Patent expiration dates:

    • April 11, 2024
      ✓ 
      Patent use: TREATMENT OF MS WITH A TABLET WITH AN ADMIXTURE OF (A) AN AMORPHOUS INCLUSION COMPLEX OF CLADRIBINE AND HYDROXYPROPYL-B-CYCLODEXTRIN AND (B) AMORPHOUS FREE CLADRIBINE AND CYCLODEXTRIN AS A NON-INCLUSION COMPLEX, CLADRIBINE/CYCLODEXTRIN 1:10-1:16 W/W
      ✓ 
      Drug product
  • Cladribine regimen for treating multiple sclerosis
    Patent 8,377,903
    Issued: February 19, 2013
    Assignee(s): Merck Serono SA

    The present invention is related to the use of Cladribine for the preparation of a pharmaceutical formulation for the treatment of multiple sclerosis, especially relapsing-remitting multiple sclerosis or early secondary progressive multiple sclerosis, wherein the preparation is to be the orally administered and wherein re-treatments are possible.

    Patent expiration dates:

    • May 31, 2026
      ✓ 
      Patent use: TREATING RRMS OR SPMS WITH ORAL CLADRIBINE: (I) 2-4 MONTHS INDUCTION WITH 1.7 MG/KG - 3.5 MG/KG CLADRIBINE; (II) CLADRIBINE-FREE PERIOD OF ABOUT 8-10 MONTHS; (III) 2-4 MONTHS MAINTENANCE WITH ABOUT 1.7 MG/KG CLADRIBINE; (IV) CLADRIBINE-FREE PERIOD
  • Oral formulations of cladribine
    Patent 8,785,415
    Issued: July 22, 2014
    Assignee(s): Ares Trading S.A.

    Provided are compositions of cladribine and cyclodextrin which are especially suited for the oral administration of cladribine.

    Patent expiration dates:

    • April 11, 2024
      ✓ 
      Patent use: TREATMENT OF MS WITH AN ADMIXTURE OF (A) AN AMORPHOUS INCLUSION COMPLEX OF CLADRIBINE (2CDA) AND CYCLODEXTRIN AND (B) AMORPHOUS FREE 2CDA AND CYCLODEXTRIN AS A NON-INCLUSION COMPLEX, FORMULATED AS A SOLID ORAL FORM, W/O SIGN. AMOUNTS OF CRYST. 2CDA
      ✓ 
      Drug product

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 29, 2022 - NEW PRODUCT

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.