Rufinamide Patent Expiration

Rufinamide is Used for managing and treating epilepsy. It was first introduced by Eisai Inc in its drug Banzel on Nov 14, 2008. 11 different companies have introduced drugs containing Rufinamide.


Rufinamide Patents

Given below is the list of patents protecting Rufinamide, along with the drug name that holds that patent and the company name owning that drug.

Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Banzel US6740669 Crystal modification of 1-(2,6-difluorobenzyl)-1H-1,2,3-triazole-4-carboxamide and its use as antiepileptic Nov 14, 2022

(Expired)

Eisai Inc
Banzel US6740669

(Pediatric)

Crystal modification of 1-(2,6-difluorobenzyl)-1H-1,2,3-triazole-4-carboxamide and its use as antiepileptic May 14, 2023

(Expired)

Eisai Inc
Banzel US7750028 Crystal modifications of 1-(2,6-difluorobenzyl)-1H-1, 2,3-triazole-4-carboxamide Oct 19, 2018

(Expired)

Eisai Inc
Banzel US7750028

(Pediatric)

Crystal modifications of 1-(2,6-difluorobenzyl)-1H-1, 2,3-triazole-4-carboxamide Apr 19, 2019

(Expired)

Eisai Inc
Banzel US8076362 Crystal modification A of 1-(2,6-difluorobenzyI)-1 H-1,2,3-triazole-4-carboxamide and dosage forms and formulations thereof Jun 08, 2018

(Expired)

Eisai Inc
Banzel US8076362

(Pediatric)

Crystal modification A of 1-(2,6-difluorobenzyI)-1 H-1,2,3-triazole-4-carboxamide and dosage forms and formulations thereof Dec 08, 2018

(Expired)

Eisai Inc


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Rufinamide Generics

Several generic applications have been filed for Rufinamide. The first generic version for Rufinamide was by Mylan Pharmaceuticals Inc and was approved on May 16, 2016. And the latest generic version is by Hetero Labs Ltd Unit Iii and was approved on Dec 5, 2023.

Given below is the list of companies who have filed for Rufinamide generic.


1. MYLAN

Mylan Pharmaceuticals Inc has filed for 2 different strengths of generic version for Rufinamide. Given below are the details of the strengths of this generic introduced by Mylan.

Strength Dosage Form Availability Application Pathway TE code Launch Date
200MG tablet Prescription ORAL AB May 16, 2016
400MG tablet Prescription ORAL AB May 16, 2016


2. BIONPHARMA

Bionpharma Inc has filed for 1 generic for Rufinamide. Given below are the details of the strengths of this generic introduced by Bionpharma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
40MG/ML suspension Prescription ORAL AB Apr 23, 2019


3. HIKMA

Hikma Pharmaceuticals International Ltd has filed for 3 different strengths of generic version for Rufinamide. Given below are the details of the strengths of this generic introduced by Hikma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
200MG tablet Prescription ORAL AB May 16, 2016
400MG tablet Prescription ORAL AB May 16, 2016
40MG/ML suspension Prescription ORAL AB Apr 23, 2019


4. CHARTWELL RX

Chartwell Rx Sciences Llc has filed for 1 generic for Rufinamide. Given below are the details of the strengths of this generic introduced by Chartwell Rx.

Strength Dosage Form Availability Application Pathway TE code Launch Date
40MG/ML suspension Prescription ORAL AB Nov 7, 2022


5. LUPIN LTD

Lupin Ltd has filed for 4 different strengths of generic version for Rufinamide. Given below are the details of the strengths of this generic introduced by Lupin Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
40MG/ML suspension Prescription ORAL AB Dec 18, 2020
100MG tablet Prescription ORAL N/A Aug 17, 2022
200MG tablet Prescription ORAL AB Aug 17, 2022
400MG tablet Prescription ORAL AB Aug 17, 2022


6. MICRO LABS

Micro Labs Ltd has filed for 2 different strengths of generic version for Rufinamide. Given below are the details of the strengths of this generic introduced by Micro Labs.

Strength Dosage Form Availability Application Pathway TE code Launch Date
200MG tablet Prescription ORAL AB May 15, 2023
400MG tablet Prescription ORAL AB May 15, 2023


7. HETERO LABS LTD III

Hetero Labs Ltd Unit Iii has filed for 3 different strengths of generic version for Rufinamide. Given below are the details of the strengths of this generic introduced by Hetero Labs Ltd Iii.

Strength Dosage Form Availability Application Pathway TE code Launch Date
200MG tablet Prescription ORAL AB May 11, 2021
400MG tablet Prescription ORAL AB May 11, 2021
40MG/ML suspension Prescription ORAL AB Dec 5, 2023


8. ALKEM LABS LTD

Alkem Laboratories Ltd has filed for 1 generic for Rufinamide. Given below are the details of the strengths of this generic introduced by Alkem Labs Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
40MG/ML suspension Prescription ORAL AB Feb 23, 2021


9. AUROBINDO PHARMA

Aurobindo Pharma Ltd has filed for 3 different strengths of generic version for Rufinamide. Given below are the details of the strengths of this generic introduced by Aurobindo Pharma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
40MG/ML suspension Prescription ORAL AB Oct 26, 2022
400MG tablet Prescription ORAL AB Jun 16, 2023
200MG tablet Prescription ORAL AB Jun 16, 2023


10. GLENMARK PHARMS LTD

Glenmark Pharmaceuticals Ltd has filed for 2 different strengths of generic version for Rufinamide. Given below are the details of the strengths of this generic introduced by Glenmark Pharms Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
200MG tablet Prescription ORAL AB May 16, 2016
400MG tablet Prescription ORAL AB May 16, 2016