Spironolactone Patent Expiration

Spironolactone is Used for managing edema in cirrhotic patients and treating heart failure with reduced ejection fraction to increase survival and reduce hospitalizations. It was first introduced by Pfizer Inc in its drug Aldactone on Dec 30, 1982. Another drug containing Spironolactone is Carospir. 27 different companies have introduced drugs containing Spironolactone.


Spironolactone Patents

Given below is the list of patents protecting Spironolactone, 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
Carospir US10493083 Spironolactone aqueous compositions Oct 28, 2036 Cmp Dev Llc
Carospir US10624906 Spironolactone aqueous compositions Oct 28, 2036 Cmp Dev Llc
Carospir US10660907 Spironolactone aqueous compositions Oct 28, 2036 Cmp Dev Llc
Carospir US10888570 Spironolactone aqueous compositions Oct 28, 2036 Cmp Dev Llc
Carospir US11389461 Spironolactone aqueous compositions Oct 28, 2036 Cmp Dev Llc
Carospir US11395828 Spironolactone aqueous compositions Oct 28, 2036 Cmp Dev Llc
Carospir US11491166 Spironolactone aqueous compositions Oct 28, 2036 Cmp Dev Llc
Carospir US9757394 Spironolactone aqueous formulations Oct 28, 2036 Cmp Dev Llc



Spironolactone's Family Patents

Family Patents

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Clinical Trials

Recent Clinical Trials on Spironolactone:

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
Spironolactone in Alcohol Use Disorder (SAUD) National Institute on Drug Abuse (NIDA) NA RECRUITING
(Sep 17, 2026)
PHASE1
Spironolactone for Pulmonary Arterial Hypertension National Institutes of Health Clinical Center (CC) NA RECRUITING
(Sep 8, 2026)
PHASE2
Regulating Blood Pressure During Recovery From Intracerebral Hemorrhage and Ischemic Stroke Yale University NA ACTIVE NOT RECRUITING
(Sep 1, 2026)
PHASE2
Efficacy and Safety of Spironolactone in Pediatric Hemodialysis Patients With Anemia. Ain Shams University NA NOT YET RECRUITING
(Jul 1, 2026)
PHASE2
Off-Label Medications for Alcohol Use Disorder Among Patients With HIV: Pilot Study 1 Yale University NA COMPLETED
(Jun 1, 2026)
PHASE2
HEART: Pilot Randomized Controlled Trial Mayo Clinic NA RECRUITING
(Jun 1, 2026)
PHASE1, PHASE2
Spironolactone to Improve Pregnancy-Associated Hypertension Trajectories Massachusetts General Hospital NA RECRUITING
(Apr 1, 2026)
PHASE2
A Study to Evaluate the Effect of Food or no Food on the Bioavailability of an Extended Release (ER) Torsemide and Spironolactone Fixed Dose Combination (FDC) Tablet in Healthy Adult Subjects Sarfez Pharmaceuticals, Inc. NA COMPLETED
(Mar 1, 2026)
PHASE3


Spironolactone Generic API Manufacturers

Several generic applications have been filed for Spironolactone. The first generic version for Spironolactone was by Ivax Pharmaceuticals Inc and was approved on Approved Prior to Jan 1, 1982. And the latest generic version is by Annora Pharma Private Ltd and was approved on Jul 25, 2025.

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


Spironolactone News

Research Analyzes Finerenone Versus Spironolactone for Managing Chronic Kidney Disease in Type 2 Diabetes

31 Oct, 2025

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