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Generic Tecfidera Availability

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 IDEC INC
    Approval date: March 27, 2013
    Strength(s): 120MG, 240MG [RLD]

Has a generic version of Tecfidera been approved?

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

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: 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.

  • Utilization of dialkyfumarates
    Patent 6,509,376
    Issued: January 21, 2003
    Inventor(s): Rajendra Kumar; Joshi & Hans-Peter; Strebel
    Assignee(s): Fumapharm AG
    The present invention relates to the use of certain dialkyl fumarates for the preparation of pharmaceutical preparations for use in transplantation medicine or for the therapy of autoimmune diseases and said compositions in the form of micro-tablets or pellets. For this purpose, the dialkyl fumarates may also be used in combination with conventional preparations used in transplantation medicine and immunosuppressive agents, especially cyclosporines.
    Patent expiration dates:
    • October 29, 2019
      ✓ 
      Drug product
  • Dimethyl fumarate for the treatment of multiple sclerosis
    Patent 7,320,999
    Issued: January 22, 2008
    Inventor(s): Joshi; Rajendra Kumar & Strebel; Hans-Peter
    Assignee(s): Fumapharm AG
    The present invention relates to the use of certain dialkyl fumarates for the preparation of pharmaceutical preparations for use in transplantation medicine or for the therapy of autoimmune diseases and said compositions in the form of micro-tablets or pellets. For this purpose, the dialkyl fumarates may also be used in combination with conventional preparations used in transplantation medicine and immunosuppressive agents, especially cyclosporines.
    Patent expiration dates:
    • May 18, 2020
      ✓ 
      Patent use: METHOD OF TREATING MULTIPLE SCLEROSIS
  • Utilization of dialkylfumarates
    Patent 7,619,001
    Issued: November 17, 2009
    Inventor(s): Joshi; Rajendra Kumar & Strebel; Hans-Peter
    Assignee(s): Biogen IDEC International GmbH
    The present invention relates to the use of certain dialkyl fumarates for the preparation of pharmaceutical preparations for use in transplantation medicine or for the therapy of autoimmune diseases and said compositions in the form of micro-tablets or pellets. For this purpose, the dialkyl fumarates may also be used in combination with conventional preparations used in transplantation medicine and immunosuppressive agents, especially cyclosporines.
    Patent expiration dates:
    • April 1, 2018
      ✓ 
      Patent use: METHOD OF TREATING MULTIPLE SCLEROSIS
  • Utilization of dialkylfumarates
    Patent 7,803,840
    Issued: September 28, 2010
    Inventor(s): Joshi; Rajendra Kumar & Strebel; Hans-Peter
    Assignee(s): Biogen Idec International GmbH
    The present invention relates to the use of certain dialkyl fumarates for the preparation of pharmaceutical preparations for use in transplantation medicine or for the therapy of autoimmune diseases and said compositions in the form of micro-tablets or pellets. For this purpose, the dialkyl fumarates may also be used in combination with conventional preparations used in transplantation medicine and immunosuppressive agents, especially cyclosporines.
    Patent expiration dates:
    • April 1, 2018
      ✓ 
      Patent use: METHOD OF TREATING AN AUTOIMMUNE DISEASE SELECTED FROM AUTOIMMUNE POLYARTHRITIS AND MULTIPLE SCLEROSIS BUT NOT TREATING PSORIATIC ARTHRITIS
  • 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
  • Utilization of dialkylfumarates
    Patent 8,524,773
    Issued: September 3, 2013
    Assignee(s): Biogen Idec International GmbH
    The present invention relates to the use of certain dialkyl fumarates for the preparation of pharmaceutical preparations for use in transplantation medicine or for the therapy of autoimmune diseases and said compositions in the form of micro-tablets or pellets. For this purpose, the dialkyl fumarates may also be used in combination with conventional preparations used in transplantation medicine and immunosuppressive agents, especially cyclosporines.
    Patent expiration dates:
    • April 1, 2018
      ✓ 
      Patent use: METHOD OF TREATING MULTIPLE SCLEROSIS
  • Utilization of dialkylfumarates
    Patent 8,759,393
    Issued: June 24, 2014
    Assignee(s): Biogen Idec International GmbH
    The present invention relates to the use of certain dialkyl fumarates for the preparation of pharmaceutical preparations for use in transplantation medicine or for the therapy of autoimmune diseases and said compositions in the form of micro-tablets or pellets. For this purpose, the dialkyl fumarates may also be used in combination with conventional preparations used in transplantation medicine and immunosuppressive agents, especially cyclosporines.
    Patent expiration dates:
    • October 29, 2019
      ✓ 
      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 27, 2018 - NEW CHEMICAL ENTITY

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.
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