Valsartan Patent Expiration

Valsartan is Used for managing hypertension and reducing cardiovascular mortality in stable patients with left ventricular failure or dysfunction post-myocardial infarction. It was first introduced by Novartis Pharmaceuticals Corp in its drug Diovan on Dec 23, 1996. Another drug containing Valsartan is Prexxartan. 26 different companies have introduced drugs containing Valsartan.


Valsartan Patents

Given below is the list of patents protecting Valsartan, along with the drug name that holds that patent and the company name owning that drug.

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Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Diovan US6294197

(Pediatric)

Solid oral dosage forms of valsartan Dec 18, 2017

(Expired)

Novartis
Diovan US6294197 Solid oral dosage forms of valsartan Jun 18, 2017

(Expired)

Novartis
Diovan US5972990

(Pediatric)

Methods for reducing risk of repeat myocardial infarction and increasing survival in heart attack victims Apr 26, 2017

(Expired)

Novartis
Diovan US5972990 Methods for reducing risk of repeat myocardial infarction and increasing survival in heart attack victims Oct 26, 2016

(Expired)

Novartis
Diovan US5399578

(Pediatric)

Acyl compounds Sep 21, 2012

(Expired)

Novartis



Valsartan's Family Patents

Family Patents

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Clinical Trials

Recent Clinical Trials on Valsartan:

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
Clinical Trials
Effects of VALsartan On atRIAl Mitral Regurgitation (VALORIA) - Pilot Jonathan Beaudoin NA RECRUITING
(Aug 1, 2026)
PHASE2, PHASE3
Bioequivalence Study of Valsatril Tablet Versus Entresto® Sacubitril/Valsartan 24/26 mg Tablet. Center for Bioequivalence Studies and Clinical Research NA COMPLETED
(Aug 1, 2026)
PHASE1
NAUTICAL: Effect of Natriuretic Peptide Augmentation on Cardiometabolic Health in Black Individuals University of Alabama at Birmingham NA RECRUITING
(Jul 1, 2026)
PHASE2
Treating Heart Dysfunction Related to Cancer Therapy With Sacubitril/Valsartan Virginia Commonwealth University NA RECRUITING
(Jul 1, 2026)
PHASE1, PHASE2
Angiotensin-Neprilysin Inhibition in Hemodialysis Initiation Brigham and Women's Hospital NA COMPLETED
(Jun 1, 2026)
PHASE2
PRECISION-BP: Precision Chronopharamacotherapy Targeting NP-RAAS-BP Rhythm Axis University of Alabama at Birmingham NA RECRUITING
(Apr 1, 2026)
PHASE2, PHASE3
Repurposing Valsartan May Protect Against Pulmonary Hypertension University of Washington NA RECRUITING
(Apr 1, 2026)
PHASE2
The ENCHANTMENT HIV Study Massachusetts General Hospital NA COMPLETED
(Mar 1, 2026)
PHASE2


Valsartan Generic API Manufacturers

Several generic applications have been filed for Valsartan. The first generic version for Valsartan was by Ohm Laboratories Inc and was approved on Jun 26, 2014. And the latest generic version is by Bostal Drug Delivery Co Ltd and was approved on Aug 11, 2026.

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


Valsartan News

Novartis faces significant challenges due to patent expirations, but the CEO has a strategy in place - pharmaphorum

04 Feb, 2026

Insights for the Biopharmaceutical Industry from the Entresto® Case | Fish & Richardson - JD Supra

27 Oct, 2025

Federal Circuit's Ruling in In re Entresto: A Significant Judgment on After-Arising Issues - Lexology

09 Oct, 2025

Novartis' Patent for Heart Failure Medication Vymada in India Declared Invalid - Medical Dialogues

18 Sep, 2025

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