Spironolactone (drug) — Competitive Intelligence Brief

Spironolactone (drug) (Spironolactone (drug)) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Potassium-sparing diuretic; Aldosterone antagonist. Area: Cardiovascular.

marketed Potassium-sparing diuretic; Aldosterone antagonist Mineralocorticoid receptor (MR) Cardiovascular Small molecule

Target snapshot

Spironolactone (drug) (Spironolactone (drug)) — University of Sao Paulo General Hospital. Spironolactone blocks aldosterone receptors in the kidney to increase sodium and water excretion while retaining potassium.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Spironolactone (drug) TARGET	Spironolactone (drug)	University of Sao Paulo General Hospital	marketed	Potassium-sparing diuretic; Aldosterone antagonist	Mineralocorticoid receptor (MR)
Inspra	EPLERENONE	Upjohn	marketed	Aldosterone Antagonist [EPC]	Mineralocorticoid receptor	2002-01-01
Aldactone	spironolactone	Generic (originally Searle/Pfizer)	marketed	Aldosterone Antagonist [EPC]	Cytochrome P450 2C19, Multidrug and toxin extrusion protein 1, Nuclear receptor subfamily 1 group I member 2	1960-01-01
Spironolacton (hexalacton(R))	Spironolacton (hexalacton(R))	Steno Diabetes Center Copenhagen	marketed	Potassium-sparing diuretic; aldosterone antagonist	Mineralocorticoid receptor (MR)
Eplerenone vs Amlodipine	Eplerenone vs Amlodipine	Brigham and Women's Hospital	marketed	Aldosterone antagonist (eplerenone); Dihydropyridine calcium channel blocker (amlodipine)	Mineralocorticoid receptor (eplerenone); L-type voltage-gated calcium channel (amlodipine)
Aldactone	Spironolactone	Pfizer Inc.	marketed	Potassium-sparing diuretic, aldosterone antagonist	Aldosterone receptors at aldosterone-dependent sodium-potassium exchange site in distal convoluted renal tubule
Renin-Angiotensin (RAAS) alone	Renin-Angiotensin (RAAS) alone	James A. Tumlin, MD	marketed	RAAS inhibitor (ACE inhibitor, ARB, direct renin inhibitor, or aldosterone antagonist)	Renin-angiotensin-aldosterone system components (ACE, AT1 receptor, renin, or aldosterone receptor)

Recent regulatory actions (last 90 days)

No regulatory actions in the last 90 days for this set.

Upcoming PDUFA dates (next 180 days)

No PDUFA dates in the next 180 days for this set.

Patent timeline (forward window)

• 2036-10-28 — Aldactone · 9757394 · Formulation · US
• 2036-10-28 — Aldactone · 11395828 · Method of Use · US
• 2036-10-28 — Aldactone · 10888570 · Formulation · US
• 2036-10-28 — Aldactone · 11389461 · Formulation · US
• 2036-10-28 — Aldactone · 10660907 · Formulation · US
• 2036-10-28 — Aldactone · 10624906 · Formulation · US
• 2036-10-28 — Aldactone · 10493083 · Formulation · US
• 2036-10-28 — Aldactone · 11491166 · Formulation · US

Sponsor landscape (Potassium-sparing diuretic; Aldosterone antagonist class)

1. National Institute of Cardiology, Warsaw, Poland · 1 drug in this class
2. University of Sao Paulo General Hospital · 1 drug in this class