Skip to Content

Generic Tecfidera Availability

Last updated on July 7, 2021.

Tecfidera is a brand name of dimethyl fumarate, approved by the FDA in the following formulation(s):

TECFIDERA (dimethyl fumarate - capsule, delayed release;oral)

  • Manufacturer: BIOGEN INC
    Approval date: March 27, 2013
    Strength(s): 120MG [RLD] [AB], 240MG [RLD] [AB]

Has a generic version of Tecfidera been approved?

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

dimethyl fumarate capsule, delayed release;oral

  • Manufacturer: ACCORD HLTHCARE
    Approval date: September 24, 2020
    Strength(s): 120MG [AB], 240MG [AB]
  • Manufacturer: ALKEM LABS LTD
    Approval date: September 24, 2020
    Strength(s): 120MG [AB], 240MG [AB]
  • Manufacturer: AMNEAL
    Approval date: September 24, 2020
    Strength(s): 120MG [AB], 240MG [AB]
  • Manufacturer: CIPLA
    Approval date: September 24, 2020
    Strength(s): 120MG [AB], 240MG [AB]
  • Manufacturer: GLENMARK PHARMS LTD
    Approval date: October 6, 2020
    Strength(s): 120MG [AB], 240MG [AB]
  • Manufacturer: HETERO LABS LTD III
    Approval date: September 24, 2020
    Strength(s): 120MG [AB], 240MG [AB]
  • Manufacturer: LUPIN ATLANTIS
    Approval date: October 5, 2020
    Strength(s): 120MG [AB], 240MG [AB]
  • Manufacturer: MSN
    Approval date: September 24, 2020
    Strength(s): 120MG [AB], 240MG [AB]
  • Manufacturer: MYLAN
    Approval date: August 17, 2020
    Strength(s): 120MG [AB], 240MG [AB]
  • Manufacturer: PHARMATHEN
    Approval date: March 26, 2021
    Strength(s): 120MG [AB], 240MG [AB]
  • Manufacturer: TWI PHARMS
    Approval date: October 14, 2020
    Strength(s): 120MG [AB], 240MG [AB]

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Tecfidera. 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 10,391,160

    Patent expiration dates:

    • March 13, 2035
      ✓ 
      Patent use: METHOD OF TREATING RELAPSING FORMS OF MULTIPLE SCLEROSIS BEFORE AND AFTER ADMINISTERING AN INACTIVE VACCINE
  • Patent 10,555,993

    Patent expiration dates:

    • March 13, 2035
      ✓ 
      Patent use: METHOD OF TREATING RELAPSING FORMS OF MULTIPLE SCLEROSIS BEFORE AND AFTER ADMINISTERING AN INACTIVE VACCINE
  • Patent 10,959,972

    Patent expiration dates:

    • November 16, 2035
      ✓ 
      Patent use: METHOD OF TREATING MULTIPLE SCLEROSIS
  • Patent 10,994,003

    Patent expiration dates:

    • March 13, 2035
      ✓ 
      Patent use: METHOD OF TREATING RELAPSING FORMS OF MULTIPLE SCLEROSIS BEFORE AND AFTER ADMINISTERING AN INACTIVE VACCINE
  • Patent 11,007,166

    Patent expiration dates:

    • November 16, 2035
      ✓ 
      Patent use: METHOD OF TREATING MULTIPLE SCLEROSIS
  • Patent 11,007,167

    Patent expiration dates:

    • November 16, 2035
      ✓ 
      Patent use: METHOD OF TREATING MULTIPLE SCLEROSIS
  • Treatment for multiple sclerosis
    Patent 8,399,514
    Issued: March 19, 2013
    Assignee(s): Biogen Idec MA Inc.

    Provided are certain methods of screening, identifying, and evaluating neuroprotective compounds useful for treatment of neurological diseases, such as, e.g., multiple sclerosis (MS). The compounds described upregulate the cellular cytoprotective pathway regulated by Nrf2. Also provided are certain methods of utilizing such compounds in therapy for neurological disease, particularly, for slowing or reducing demyelination, axonal loss, or neuronal and oligodendrocyte death.

    Patent expiration dates:

    • February 7, 2028
      ✓ 
      Patent use: METHOD OF TREATING MULTIPLE SCLEROSIS

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:

    • February 5, 2023 - INFORMATION ADDED TO THE LABELING DESCRIBING A RANDOMIZED, OPEN-LABEL STUDY THAT EXAMINED THE CONCOMITANT USE OF DIMETHYL FUMARATE AND SEVERAL NON-LIVE VACCINES IN ADULTS 27-55 YEARS OF AGE WITH RELAPSING FORMS OF MULTIPLE SCLEROSIS

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.