Generic Banzel Availability

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

BANZEL (rufinamide - suspension;oral)

  • Manufacturer: EISAI INC
    Approval date: March 3, 2011
    Strength(s): 40MG/ML [RLD]

BANZEL (rufinamide - tablet;oral)

  • Manufacturer: EISAI INC
    Approval date: November 14, 2008
    Strength(s): 200MG, 400MG [RLD]

Has a generic version of Banzel been approved?

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

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

  • Crystal modification of 1-(2,6-difluorobenzyl)-1H-1,2,3-triazole-4-carboxamide and its use as antiepileptic
    Patent 6,740,669
    Issued: May 25, 2004
    Inventor(s): Robert; Portmann & Urs Christoph; Hofmeier & Andreas; Burkhard & Walter; Scherrer & Martin; Szelagiewicz
    Assignee(s): Novartis AG
    The invention relates to the novel modification A or A′ of the compound 1-(2,6-difluorobenzyl)-1H-1,2,3-triazole-4-carboxamide of the formula its use and pharmaceutical preparations comprising this crystal modification.
    Patent expiration dates:
    • November 14, 2022
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      Drug substance
      ✓ 
      Drug product
  • Crystal modifications of 1-(2,6-difluorobenzyl)-1H-1, 2,3-triazole-4-carboxamide
    Patent 7,750,028
    Issued: July 6, 2010
    Inventor(s): Portmann; Robert & Hofmeier; Urs C & Burkhard; Andreas & Scherrer; Walter & Szelagiewicz; Martin
    Assignee(s): Novartis AG
    The invention relates to the novel modifications B and C of the compound 1-(2,6-difluorobenzyl)-1H-1,2,3-triazole-4-carboxamide of the formula its use and pharmaceutical preparations comprising this crystal modifications.
    Patent expiration dates:
    • October 19, 2018
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      Patent use: TREATMENT OF EPILEPSY
  • Crystal modification A of 1-(2,6-difluorobenzyI)-1 H-1,2,3-triazole-4-carboxamide and dosage forms and formulations thereof
    Patent 8,076,362
    Issued: December 13, 2011
    Inventor(s): Portmann; Robert & Hofmeier; Urs Christoph & Burkhard; Andreas & Scherrer; Walter & Szelagiewicz; Martin
    Assignee(s): Novartis AG
    The invention relates to dosage forms and formulations comprising the novel crystal modification A of the compound I-(2,6-difluorobenzyl)-I H-I,2,3-triazole-4-carboxamide, wherein crystal modification A is characterized by characteristic lines with interplanar spacings (d values) of 10.5 Å, 5.14 Å, 4.84 Å, 4.55 Å, 4.34 Å, 4.07 Å, 3.51 Å, 3.48 Å, 3.25 Å, 3.19 Å, 3.15 Å, 3.07 Å, and 2.81 Å, determined by means of an X-ray powder pattern. Dosage forms of crystal modification A of the compound I-(2,6-difluorobenzyl)-I H-I,2,3-triazole-4-carboxamide may be for oral or parenteral administration, in the form of a solid or liquid, and in a dosage range of 20 mg to less than 500 mg. Solid dosage forms comprise a tablet or capsule, and further comprise a pharmaceutically-acceptable carrier and film-coat.
    Patent expiration dates:
    • June 8, 2018
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      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:
    • November 14, 2013 -
    • November 14, 2015 -

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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