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
(Expired) | Otsuka |
| Samsca | US8501730 | Process for preparing benzazepine compounds or salts thereof |
Sep 01, 2026
(Expired) | 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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Clinical Trials
Recent Clinical Trials on Tolvaptan:
Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.
| Title | Lead Sponsor | Collaborators | Status | Phases |
|---|---|---|---|---|
 | ||||
| A Study to See if Tolvaptan is Safe in Infants and Children Who at Enrollment Are 28 Days to Less Than 18 Years Old With Autosomal Recessive Polycystic Kidney Disease (ARPKD) | Otsuka Pharmaceutical Development & Commercialization, Inc. | NA |
RECRUITING
(Aug 1, 2026)
| PHASE3 |
| "SALT Trial" Study of Ascending Levels of Tolvaptan in Hyponatremia | Otsuka Pharmaceutical Development & Commercialization, Inc. | NA |
COMPLETED
(Jul 1, 2026)
| PHASE3 |
| Study of Ascending Levels of Tolvaptan in Hyponatremia | Otsuka Pharmaceutical Development & Commercialization, Inc. | NA |
COMPLETED
(Jul 1, 2026)
| PHASE3 |