Riluzole Patent Expiration
Riluzole was first introduced by Covis Pharma Gmbh
Riluzole Patents
Given below is the list of patents protecting Riluzole, 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 |
|---|---|---|---|---|
| Tiglutik Kit | US8765150 | Riluzole aqueous suspensions | Mar 12, 2029 | Italfarmaco Sa |
| Exservan | US8603514 | Uniform films for rapid dissolve dosage form incorporating taste-masking compositions |
Apr 03, 2024
(Expired) | Aquestive |
| Exservan | US8765167 | Uniform films for rapid-dissolve dosage form incorporating anti-tacking compositions |
Feb 20, 2024
(Expired) | Aquestive |
| Rilutek | US5527814 | Use of 2-amino-6-(trifluoromethoxy)benzothiazole for obtaining a medicament for the treatment of amyotrophic lateral sclerosis |
Jun 18, 2013
(Expired) | Covis |
A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Riluzole's patents.
Latest Legal Activities on Riluzole's Patents
Given below is the list recent legal activities going on the following patents of Riluzole.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 03 Jan, 2022 | US8765150 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 02 Jan, 2018 | US8765150 |
| Recordation of Patent Grant Mailed Critical | 01 Jul, 2014 | US8765150 |
| Patent Issue Date Used in PTA Calculation Critical | 01 Jul, 2014 | US8765150 |
| Email Notification Critical | 12 Jun, 2014 | US8765150 |
| Issue Notification Mailed Critical | 11 Jun, 2014 | US8765150 |
| Dispatch to FDC | 29 May, 2014 | US8765150 |
| Mail Miscellaneous Communication to Applicant | 27 May, 2014 | US8765150 |
| Printer Rush- No mailing | 27 May, 2014 | US8765150 |
| Email Notification Critical | 27 May, 2014 | US8765150 |
Riluzole's Family Patents
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Riluzole Generic API Manufacturers
Several generic applications have been filed for Riluzole. The first generic version for Riluzole was by Impax Laboratories Inc and was approved on Jan 29, 2003. And the latest generic version is by Alkem Laboratories Ltd and was approved on Aug 22, 2024.
Given below is the list of companies who have filed for Riluzole generic, along with the locations of their manufacturing plants worldwide.
1. ALKEM LABS LTD
Alkem Laboratories Ltd has filed for 2 different strengths of generic version for Riluzole. 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 |
|---|---|---|---|---|---|
| 50MG
(reference standard) | tablet | Prescription | ORAL | AB | Mar 30, 2016 |
| 50MG/10ML | suspension | Prescription | ORAL | AB | Aug 22, 2024 |
2. APOTEX CORP
Apotex Corp has filed for 1 generic for Riluzole. Given below are the details of the strengths of this generic introduced by Apotex Corp.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 50MG | tablet | Discontinued | ORAL | N/A | Jun 18, 2013 |
Manufacturing Plant Locations New
Apotex Corp'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 Apotex Corp as present at those locations.
| Country | City | Firm Name | ||
|---|---|---|---|---|
| United States |
| |||
3. DAITO PHARMS CO LTD
Daito Pharmaceuticals Co Ltd has filed for 1 generic for Riluzole. Given below are the details of the strengths of this generic introduced by Daito Pharms Co Ltd.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 50MG | tablet | Discontinued | ORAL | N/A | Oct 16, 2018 |
4. GLENMARK PHARMS LTD
Glenmark Pharmaceuticals Ltd has filed for 1 generic for Riluzole. 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 |
|---|---|---|---|---|---|
| 50MG | tablet | Prescription | ORAL | AB | Jun 18, 2013 |
5. IMPAX LABS
Impax Laboratories Inc has filed for 1 generic for Riluzole. Given below are the details of the strengths of this generic introduced by Impax Labs.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 50MG | tablet | Prescription | ORAL | AB | Jan 29, 2003 |
6. KENTON
Kenton Chemicals And Pharmaceuticals Corp has filed for 1 generic for Riluzole. Given below are the details of the strengths of this generic introduced by Kenton.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 50MG | tablet | Prescription | ORAL | AB | Dec 9, 2019 |
Manufacturing Plant Locations New
Kenton'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 Kenton as present at those locations.
| Country | City | Firm Name | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| United States |
| |||||||||
7. NORVIUM BIOSCIENCE
Norvium Bioscience Llc has filed for 1 generic for Riluzole. 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 |
|---|---|---|---|---|---|
| 50MG | tablet | Prescription | ORAL | AB | Jul 1, 2013 |
8. SUN PHARM INDS LTD
Sun Pharmaceutical Industries Ltd has filed for 1 generic for Riluzole. Given below are the details of the strengths of this generic introduced by Sun Pharm Inds Ltd.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 50MG | tablet | Discontinued | ORAL | N/A | Jun 18, 2013 |