Safinamide Mesylate Patent Expiration
Safinamide Mesylate is Used for managing 'off' episodes in patients with Parkinson's disease who are already taking levodopa/carbidopa. It was first introduced by Mdd Us Operations Llc
Safinamide Mesylate Patents
Given below is the list of patents protecting Safinamide Mesylate, 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 |
|---|---|---|---|---|
| Xadago | US8283380 | Methods for treatment of parkinson's disease | Mar 21, 2031 | Mdd Us |
| Xadago | US8076515 | Process for the production of 2-[4-(3- and 2-fluorobenzyloxy) benzylamino] propanamides | Dec 10, 2028 | Mdd Us |
| Xadago | US8278485 | Process for the production of 2-[4-(3- and 2-fluorobenzyloxy) benzylamino] propanamides | Jun 08, 2027 | Mdd Us |
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 Safinamide Mesylate's patents.
Latest Legal Activities on Safinamide Mesylate's Patents
Given below is the list recent legal activities going on the following patents of Safinamide Mesylate.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 09 Apr, 2024 | US8283380 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 02 Apr, 2024 | US8278485 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 13 Jun, 2023 | US8076515 |
| Patent Term Extension Certificate Critical | 21 May, 2021 | US8283380 |
| Withdrawal of Application for PTE Critical | 20 May, 2021 | US8076515 |
| Election in Response to Notice of Final Determination | 16 Mar, 2021 | US8283380 |
| Notice of Final Determination -Election Required | 09 Mar, 2021 | US8283380 |
| Notice of Final Determination -Election Required | 09 Mar, 2021 | US8076515 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 09 Apr, 2020 | US8283380 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 02 Apr, 2020 | US8278485 |
Safinamide Mesylate's Family Patents
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Safinamide Mesylate Generic API Manufacturers
Several generic applications have been filed for Safinamide Mesylate. The first generic version for Safinamide Mesylate was by Aurobindo Pharma Ltd and was approved on Jun 14, 2023. And the latest generic version is by Zenara Pharma Private Ltd and was approved on Jun 13, 2025.
Given below is the list of companies who have filed for Safinamide Mesylate generic, along with the locations of their manufacturing plants worldwide.
1. AUROBINDO PHARMA
Aurobindo Pharma Ltd has filed for 2 different strengths of generic version for Safinamide Mesylate. 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 |
|---|---|---|---|---|---|
| EQ 100MG BASE | tablet | Discontinued | ORAL | N/A | Jun 14, 2023 |
| EQ 50MG BASE | tablet | Discontinued | ORAL | N/A | Jun 14, 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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2. MSN
Msn Laboratories Private Ltd has filed for 2 different strengths of generic version for Safinamide Mesylate. Given below are the details of the strengths of this generic introduced by Msn.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 100MG BASE | tablet | Prescription | ORAL | AB | Dec 31, 2024 |
| EQ 50MG BASE | tablet | Prescription | ORAL | AB | Dec 31, 2024 |
Manufacturing Plant Locations New
Msn'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 Msn as present at those locations.
| Country | City | Firm Name | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| India |
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| United States |
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3. PRINSTON INC
Prinston Pharmaceutical Inc has filed for 2 different strengths of generic version for Safinamide Mesylate. Given below are the details of the strengths of this generic introduced by Prinston Inc.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 50MG BASE | tablet | Prescription | ORAL | AB | Apr 25, 2024 |
| EQ 100MG BASE | tablet | Prescription | ORAL | AB | Apr 25, 2024 |
4. ZENARA
Zenara Pharma Private Ltd has filed for 2 different strengths of generic version for Safinamide Mesylate. Given below are the details of the strengths of this generic introduced by Zenara.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 50MG BASE | tablet | Prescription | ORAL | AB | Jun 13, 2025 |
| EQ 100MG BASE | tablet | Prescription | ORAL | AB | Jun 13, 2025 |
Manufacturing Plant Locations New
Zenara'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 Zenara as present at those locations.
| Country | City | Firm Name | ||
|---|---|---|---|---|
| India |
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