Irbesartan Patent Expiration

Irbesartan was first introduced by Sanofi Aventis Us Llc in its drug Avapro on Sep 30, 1997. 24 different companies have introduced drugs containing Irbesartan.


Irbesartan Patents

Given below is the list of patents protecting Irbesartan, 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
Avapro US6342247

(Pediatric)

Pharmaceutical compositions containing irbesartan Dec 07, 2015

(Expired)

Sanofi Aventis Us
Avapro US6342247 Pharmaceutical compositions containing irbesartan Jun 07, 2015

(Expired)

Sanofi Aventis Us



Irbesartan's Family Patents

Family Patents

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Clinical Trials

Recent Clinical Trials on Irbesartan:

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
ETA and AT1 Antagonism in ANCA-vasculitis (SPARVASC) University of Edinburgh NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE2
Evaluation of Irbesartan on Hepatic Fibrosis in Chronic Hepatitis C ANRS, Emerging Infectious Diseases NA COMPLETED
(Apr 1, 2026)
PHASE3
Study of Sparsentan in Patients With Primary Focal Segmental Glomerulosclerosis (FSGS) Travere Therapeutics, Inc. NA COMPLETED
(Apr 1, 2026)
PHASE3
A Study of the Effect and Safety of HS-10390 in the Treatment of Participants With Chronic Kidney Disease Jiangsu Hansoh Pharmaceutical Co., Ltd. NA NOT YET RECRUITING
(Apr 1, 2026)
PHASE2


Irbesartan Generic API Manufacturers

Several generic applications have been filed for Irbesartan. The first generic version for Irbesartan was by Teva Pharmaceuticals Usa and was approved on Mar 30, 2012. And the latest generic version is by Msn Laboratories Private Ltd and was approved on Nov 4, 2025.

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