Tolvaptan Patent Expiration
Tolvaptan is Used for treating low levels of sodium in the blood (hyponatremia). It was first introduced by Otsuka Pharmaceutical Co Ltd
Tolvaptan Patents
Given below is the list of patents protecting Tolvaptan, 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 |
|---|---|---|---|---|
| Jynarque | US10905694 | Pharmaceutical solid preparation comprising benzazepines and production method thereof | Apr 07, 2030 | Otsuka |
| Samsca | US10905694 | Pharmaceutical solid preparation comprising benzazepines and production method thereof | Apr 07, 2030 | Otsuka |
| Jynarque | US8501730 | Process for preparing benzazepine compounds or salts thereof | Sep 01, 2026 | Otsuka |
| Samsca | US8501730 | Process for preparing benzazepine compounds or salts thereof | Sep 01, 2026 | Otsuka |
| Jynarque | US5753677 | Benzoheterocyclic compounds |
May 19, 2020
(Expired) | Otsuka |
| Jynarque | US5972882 | Treatment of polycystic kidney disease using vasopressin V2 receptor antagonists |
Dec 14, 2018
(Expired) | Otsuka |
| Samsca | US5753677 | Benzoheterocyclic compounds |
May 19, 2015
(Expired) | Otsuka |
| Samsca | US5258510 | Benzoheterocyclic compounds |
Nov 02, 2012
(Expired) | Otsuka |
Tolvaptan's Family Patents
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Tolvaptan Generic API Manufacturers
Several generic applications have been filed for Tolvaptan. The first generic version for Tolvaptan was by Alkem Laboratories Ltd and was approved on May 19, 2020. And the latest generic version is by Msn Laboratories Private Ltd and was approved on Jun 21, 2023.
Given below is the list of companies who have filed for Tolvaptan generic, along with the locations of their manufacturing plants worldwide.
1. ALKEM LABS LTD
Alkem Laboratories Ltd has filed for 3 different strengths of generic version for Tolvaptan. 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 |
|---|---|---|---|---|---|
| 30MG | tablet | Prescription | ORAL | AB | May 19, 2020 |
| 60MG | tablet | Prescription | ORAL | N/A | May 19, 2020 |
| 15MG | tablet | Prescription | ORAL | AB | Sep 6, 2022 |
2. APOTEX
Apotex Inc has filed for 2 different strengths of generic version for Tolvaptan. Given below are the details of the strengths of this generic introduced by Apotex.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 30MG | tablet | Prescription | ORAL | AB | May 19, 2020 |
| 15MG | tablet | Prescription | ORAL | AB | Sep 6, 2022 |
Manufacturing Plant Locations New
Apotex's manufacturing plants are situated in 3 countries - United States, Canada, India. Given below are the details of these plant locations as well as the firm names of Apotex as present at those locations.
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| United States |
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| Canada |
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| India |
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3. ENDO OPERATIONS
Endo Operations Ltd has filed for 2 different strengths of generic version for Tolvaptan. Given below are the details of the strengths of this generic introduced by Endo Operations.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 15MG | tablet | Prescription | ORAL | AB | Feb 15, 2022 |
| 30MG | tablet | Prescription | ORAL | AB | Feb 15, 2022 |
4. HETERO LABS LTD V
Hetero Labs Ltd Unit V has filed for 2 different strengths of generic version for Tolvaptan. Given below are the details of the strengths of this generic introduced by Hetero Labs Ltd V.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 30MG | tablet | Prescription | ORAL | AB | Jul 16, 2021 |
| 15MG | tablet | Prescription | ORAL | AB | Sep 6, 2022 |
5. MSN
Msn Laboratories Private Ltd has filed for 2 different strengths of generic version for Tolvaptan. Given below are the details of the strengths of this generic introduced by Msn.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 15MG | tablet | Prescription | ORAL | AB | Jun 21, 2023 |
| 30MG | tablet | Prescription | ORAL | AB | Jun 21, 2023 |
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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