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 in its drug Samsca on May 19, 2009. Another drug containing Tolvaptan is Jynarque. 6 different companies have introduced drugs containing Tolvaptan.


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
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
Jynarque US8501730 Process for preparing benzazepine compounds or salts thereof Sep 01, 2026 Otsuka
Samsca US10905694 Pharmaceutical solid preparation comprising benzazepines and production method thereof Apr 07, 2030 Otsuka
Samsca US5258510 Benzoheterocyclic compounds Nov 02, 2012

(Expired)

Otsuka
Samsca US5753677 Benzoheterocyclic compounds May 19, 2015

(Expired)

Otsuka
Samsca US8501730 Process for preparing benzazepine compounds or salts thereof Sep 01, 2026 Otsuka


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Tolvaptan Generics

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.


1. 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


2. 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


3. 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


4. 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


5. 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