Skip to Content

Generic Bafiertam Availability

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

BAFIERTAM (monomethyl fumarate - capsule, delayed release;oral)

  • Manufacturer: BANNER LIFE SCIENCES
    Approval date: April 28, 2020
    Strength(s): 95MG [RLD]

Has a generic version of Bafiertam been approved?

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

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

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.

  • Fumarate esters
    Patent 10,098,863
    Issued: October 16, 2018
    Assignee(s): Banner Life Sciences LLC

    Described herein are pharmaceutical compositions comprising one or more fumarate esters, processes for making the same, and compositions and methods for treating multiple sclerosis subjects with the compositions. In particular, oral pharmaceutical compositions comprising fumarate esters in liquid vehicles are described. One embodiment is an oral delayed release pharmaceutical dosage form comprising a soft capsule encapsulating an immediate releasing liquid comprising one or more fumarate esters.

    Patent expiration dates:

    • February 27, 2035
      ✓ 
      Patent use: METHOD OF TREATING MULTIPLE SCLEROSIS
      ✓ 
      Drug product
  • Fumarate ester dosage forms
    Patent 10,105,335
    Issued: October 23, 2018
    Assignee(s): Banner Life Sciences LLC

    Described herein are pharmaceutical compositions comprising fumarate esters, methods for making the same, and methods for treating subjects in need thereof. In particular, oral controlled release pharmaceutical compositions comprising fumarate esters suspended in liquid matrices are described. One embodiment described herein is a pharmaceutical composition comprising fumarate esters suspended in a lipid or lipophilic liquid with enhanced bioavailability.

    Patent expiration dates:

    • February 27, 2035
      ✓ 
      Drug product
  • Fumarate ester pharmaceutical compositions
    Patent 10,105,336
    Issued: October 23, 2018
    Assignee(s): Banner Life Sciences LLC

    Described herein are pharmaceutical compositions comprising fumarate esters, methods for making the same, and methods for treating subjects in need thereof. In particular, oral pharmaceutical compositions comprising fumarate esters are described.

    Patent expiration dates:

    • February 27, 2035
      ✓ 
      Patent use: METHOD OF TREATING MULTIPLE SCLEROSIS
      ✓ 
      Drug product
  • Fumarate ester pharmaceutical compositions
    Patent 10,105,337
    Issued: October 23, 2018
    Assignee(s): Banner Life Sciences LLC

    Described herein are pharmaceutical compositions comprising fumarate esters, methods for making the same, and methods for treating subjects in need thereof. In particular, oral pharmaceutical compositions comprising fumarate esters are described.

    Patent expiration dates:

    • February 27, 2035
      ✓ 
      Drug product
  • Controlled release fumarate esters
    Patent 9,326,947
    Issued: May 3, 2016
    Assignee(s): Banner Life Sciences LLC

    Described herein are pharmaceutical compositions comprising fumarate esters, methods for making the same, and methods for treating subjects in need thereof. In particular, oral pharmaceutical compositions comprising controlled release fumarate esters are described.

    Patent expiration dates:

    • February 27, 2035
      ✓ 
      Drug product
  • Controlled release fumarate esters
    Patent 9,326,965
    Issued: May 3, 2016
    Assignee(s): Banner Life Sciences LLC

    Described herein are pharmaceutical compositions comprising fumarate esters, methods for making the same, and methods for treating subjects in need thereof. In particular, oral pharmaceutical compositions comprising controlled release fumarate esters are described.

    Patent expiration dates:

    • February 27, 2035
      ✓ 
      Patent use: METHOD OF TREATING MULTIPLE SCLEROSIS
  • Fumarate ester pharmaceutical compositions
    Patent 9,511,043
    Issued: December 6, 2016
    Assignee(s): Banner Life Sciences LLC

    Described herein are pharmaceutical compositions comprising fumarate esters, methods for making the same, and methods for treating subjects in need thereof. In particular, oral pharmaceutical compositions comprising fumarate esters are described.

    Patent expiration dates:

    • February 27, 2035
      ✓ 
      Patent use: METHOD OF TREATING MULTIPLE SCLEROSIS
  • Fumarate ester pharmaceutical compositions
    Patent 9,517,209
    Issued: December 13, 2016
    Assignee(s): Banner Life Sciences LLC

    Described herein are pharmaceutical compositions comprising fumarate esters, methods for making the same, and methods for treating subjects in need thereof. In particular, oral pharmaceutical compositions comprising fumarate esters are described.

    Patent expiration dates:

    • February 27, 2035
      ✓ 
      Drug product
  • Fumarate ester dosage forms
    Patent 9,566,259
    Issued: February 14, 2017
    Assignee(s): BANNER LIFE SCIENCES LLC

    Described herein are pharmaceutical compositions comprising fumarate esters, methods for making the same, and methods for treating subjects in need thereof. In particular, oral controlled release pharmaceutical compositions comprising fumarate esters suspended in liquid matrices are described. One embodiment described herein is a pharmaceutical composition comprising fumarate esters suspended in a lipid or lipophilic liquid with enhanced bioavailability.

    Patent expiration dates:

    • February 27, 2035
      ✓ 
      Drug product
  • Fumarate ester dosage forms
    Patent 9,636,318
    Issued: May 2, 2017
    Assignee(s): BANNER LIFE SCIENCES LLC

    Described herein are pharmaceutical compositions comprising fumarate esters, methods for making the same, and methods for treating subjects in need thereof. In particular, oral controlled release pharmaceutical compositions comprising fumarate esters suspended in liquid matrices are described. One embodiment described herein is a pharmaceutical composition comprising fumarate esters suspended in a lipid or lipophilic liquid with enhanced bioavailability.

    Patent expiration dates:

    • February 27, 2035
      ✓ 
      Patent use: METHOD OF TREATING MULTIPLE SCLEROSIS
  • Fumarate ester dosage forms
    Patent 9,636,319
    Issued: May 2, 2017
    Assignee(s): BANNER LIFE SCIENCES LLC

    Described herein are pharmaceutical compositions comprising fumarate esters, methods for making the same, and methods for treating subjects in need thereof. In particular, oral controlled release pharmaceutical compositions comprising fumarate esters suspended in liquid matrices are described. One embodiment described herein is a pharmaceutical composition comprising fumarate esters suspended in a lipid or lipophilic liquid with enhanced bioavailability.

    Patent expiration dates:

    • February 27, 2035
      ✓ 
      Drug product
  • Patent 9,814,691

    Patent expiration dates:

    • February 27, 2035
      ✓ 
      Patent use: METHOD OF TREATING MULTIPLE SCLEROSIS
  • Patent 9,814,692

    Patent expiration dates:

    • February 27, 2035
      ✓ 
      Patent use: METHOD OF TREATING MULTIPLE SCLEROSIS
  • Fumarate ester pharmaceutical compositions
    Patent 9,820,960
    Issued: November 21, 2017
    Assignee(s): Banner Life Sciences LLC

    Described herein are pharmaceutical compositions comprising fumarate esters, methods for making the same, and methods for treating subjects in need thereof. In particular, oral pharmaceutical compositions comprising fumarate esters are described.

    Patent expiration dates:

    • February 27, 2035
      ✓ 
      Drug product
  • Fumarate ester dosage forms
    Patent 9,820,961
    Issued: November 21, 2017
    Assignee(s): BANNER LIFE SCIENCES LLC

    Described herein are pharmaceutical compositions comprising fumarate esters, methods for making the same, and methods for treating subjects in need thereof. In particular, oral controlled release pharmaceutical compositions comprising fumarate esters suspended in liquid matrices are described. One embodiment described herein is a pharmaceutical composition comprising fumarate esters suspended in a lipid or lipophilic liquid with enhanced bioavailability.

    Patent expiration dates:

    • February 27, 2035
      ✓ 
      Patent use: METHOD OF TREATING MULTIPLE SCLEROSIS
      ✓ 
      Drug product

Further information

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

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.