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

(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 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 US7750028

(Pediatric)

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

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

(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



Rufinamide's Family Patents

Family Patents

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Rufinamide Generic API Manufacturers

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, along with the locations of their manufacturing plants worldwide.


1. 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





2. 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


Manufacturing Plant Locations
New

Aurobindo Pharma's manufacturing plants are situated in 2 countries - India, United States. Given below are the details of these plant locations as well as the firm names of Aurobindo Pharma as present at those locations.

Country City Firm Name
India
Medchal Aurobindo Pharma Ltd
Sangareddy Aurobindo Pharma Limited
Polepally, Mahaboob Nagar Aurobindo Pharma Limited
Bachupally Aurobindo Pharma Limited
United States
East Windsor Aurobindo Pharma USA Inc





3. 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


Manufacturing Plant Locations
New

Bionpharma's manufacturing plants are situated in 1 country - United States. Given below are the details of these plant locations as well as the firm names of Bionpharma as present at those locations.

Country City Firm Name
United States
Princeton Bionpharma Inc.





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. 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





6. 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





7. 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


Manufacturing Plant Locations
New

Hikma's manufacturing plants are situated in 3 countries - United States, Portugal, Jordan. Given below are the details of these plant locations as well as the firm names of Hikma as present at those locations.

Country City Firm Name
United States
Eatontown Hikma Pharmaceuticals USA, Inc.
Cherry Hill Hikma Pharmaceuticals USA Inc.
Dayton Hikma Injectables USA Inc
Carlsbad Hikma Cali Inc. DBA Leucadia Pharmaceuticals
Portugal
Terrugem Snt Hikma Farmaceutica, (Portugal) S.A.
Jordan
Amman Hikma Pharmaceuticals LLC





8. 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


Manufacturing Plant Locations
New

Lupin Ltd's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Lupin Ltd as present at those locations.

Country City Firm Name
India
Aurangabad Lupin Ltd.





9. 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


Manufacturing Plant Locations
New

Micro Labs's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Micro Labs as present at those locations.

Country City Firm Name
India
Bangalore Micro Labs Limited
Verna Micro Labs Limited
Bengaluru Micro Labs Limited
Bengaluru Micro Labs Limited, Central Analytical Laboratory





10. 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


Manufacturing Plant Locations
New

Mylan's manufacturing plants are situated in 4 countries - United States, India, Canada, Ireland. Given below are the details of these plant locations as well as the firm names of Mylan as present at those locations.

Country City Firm Name
United States
San Carlos Mylan Pharmaceuticals Inc.
Rockford Mylan Institutional, Inc.
Santa Barbara Mylandon LLC dba Debbie s Delights Santa Barbara Baking Co.
Morgantown Mylan Specialty, L.P.
Greensboro Mylan Pharmaceuticals Inc
Saint Albans Mylan Technologies, Inc.
Morgantown MYLAN CONSUMER HEALTHCARE Inc.
India
Sinnar Mylan Laboratories Limited
Aurangabad Mylan Laboratories Limited (FDF-2)
Hosur Mylan Laboratories Limited
Bangalore Mylan Laboratories Limited
Hyderabad Mylan Laboratories Limited
Sarigam Mylan Laboratories Limited
Pithampur, District Dhar Mylan Laboratories Limited
Anekal Taluk, Bangalore Mylan Laboratories Limited
Canada
Etobicoke Mylan Pharmaceuticals ULC
Ireland
Inverin Mylan Teoranta