Rufinamide Patent Expiration
Rufinamide is Used for managing and treating epilepsy. It was first introduced by Eisai Inc
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
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Rufinamide Generic API Manufacturers
Several generic applications have been filed for Rufinamide. The first generic version for Rufinamide was by Norvium Bioscience Llc 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 |
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| United States |
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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 |
| |||
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 |
| |||||||||
| Portugal |
| |||||||||
| Jordan |
| |||||||||
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 |
| |||
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 |
| |||||||||
10. NORVIUM BIOSCIENCE
Norvium Bioscience Llc has filed for 2 different strengths of generic version for Rufinamide. Given below are the details of the strengths of this generic introduced by Norvium Bioscience.
| 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 |