Generic Banzel Availability
Last updated on Sep 11, 2024.
Banzel is a brand name of rufinamide, approved by the FDA in the following formulation(s):
BANZEL (rufinamide - suspension;oral)
BANZEL (rufinamide - tablet;oral)
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Manufacturer: EISAI INC
Approval date: November 14, 2008
Strength(s): 100MG (discontinued) [RLD], 200MG [RLD] [AB], 400MG [RLD] [AB]
Has a generic version of Banzel been approved?
Yes. The following products are equivalent to Banzel:
rufinamide suspension;oral
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Manufacturer: ALKEM LABS LTD
Approval date: February 23, 2021
Strength(s): 40MG/ML [AB] -
Manufacturer: AUROBINDO PHARMA
Approval date: October 26, 2022
Strength(s): 40MG/ML [AB] -
Manufacturer: BIONPHARMA
Approval date: April 23, 2019
Strength(s): 40MG/ML [AB] -
Manufacturer: CHARTWELL RX
Approval date: November 7, 2022
Strength(s): 40MG/ML [AB] -
Manufacturer: HETERO LABS LTD III
Approval date: December 5, 2023
Strength(s): 40MG/ML [AB] -
Manufacturer: HIKMA
Approval date: April 23, 2019
Strength(s): 40MG/ML [AB] -
Manufacturer: LUPIN LTD
Approval date: December 18, 2020
Strength(s): 40MG/ML [AB]
rufinamide tablet;oral
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Manufacturer: AUROBINDO PHARMA
Approval date: June 16, 2023
Strength(s): 200MG [AB], 400MG [AB] -
Manufacturer: GLENMARK PHARMS LTD
Approval date: May 16, 2016
Strength(s): 200MG [AB], 400MG [AB] -
Manufacturer: HETERO LABS LTD III
Approval date: May 11, 2021
Strength(s): 200MG [AB], 400MG [AB] -
Manufacturer: HIKMA
Approval date: May 16, 2016
Strength(s): 200MG [AB], 400MG [AB] -
Manufacturer: LUPIN LTD
Approval date: August 17, 2022
Strength(s): 200MG [AB], 400MG [AB] -
Manufacturer: MICRO LABS
Approval date: May 15, 2023
Strength(s): 200MG [AB], 400MG [AB] -
Manufacturer: MYLAN
Approval date: May 16, 2016
Strength(s): 200MG [AB], 400MG [AB]
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: Generic Drug FAQ.
More about Banzel (rufinamide)
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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.