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. 7 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
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

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 Apotex Inc and was approved on May 19, 2020. And the latest generic version is by Lupin Ltd and was approved on Apr 23, 2025.

Given below is the list of companies who have filed for Tolvaptan generic, along with the locations of their manufacturing plants worldwide.