ALDACTONE Drug Patent Profile

Which patents cover Aldactone, and what generic alternatives are available?

Aldactone is a drug marketed by Pfizer and is included in one NDA.

The generic ingredient in ALDACTONE is spironolactone. There are sixteen drug master file entries for this compound. Forty suppliers are listed for this compound. Additional details are available on the spironolactone profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Aldactone

A generic version of ALDACTONE was approved as spironolactone by SUN PHARM INDUSTRIES on July 23^rd, 1986.

Summary for ALDACTONE

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	72
Clinical Trials:	50
Patent Applications:	4,432
Drug Prices:	Drug price information for ALDACTONE
What excipients (inactive ingredients) are in ALDACTONE?	ALDACTONE excipients list
DailyMed Link:	ALDACTONE at DailyMed

See drug prices for ALDACTONE

Recent Clinical Trials for ALDACTONE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Sarfez Pharmaceuticals, Inc.	PHASE3
SPH Sine Pharmaceutical Laboratories Co., Ltd.	PHASE1
Thomas Jefferson University	Phase 1

See all ALDACTONE clinical trials

Pharmacology for ALDACTONE

Drug Class	Aldosterone Antagonist
Mechanism of Action	Aldosterone Antagonists

US Patents and Regulatory Information for ALDACTONE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pfizer	ALDACTONE	spironolactone	TABLET;ORAL	012151-009	Dec 30, 1983	AB	RX	Yes	No
Pfizer	ALDACTONE	spironolactone	TABLET;ORAL	012151-008	Dec 30, 1982	AB	RX	Yes	No
Pfizer	ALDACTONE	spironolactone	TABLET;ORAL	012151-010	Dec 30, 1983	AB	RX	Yes	Yes

EU/EMA Drug Approvals for ALDACTONE

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Ceva Santé Animale	Spironolactone Ceva	spironolactone	EMEA/V/C/000105For use in combination with standard therapy (including diuretic support, where necessary) for the treatment of congestive heart failure caused by valvular regurgitation in dogs.	Withdrawn	no	no	no	2007-06-20
Nova Laboratories Ireland Limited	Qaialdo	spironolactone	EMEA/H/C/005535In the management of refractory oedema associated with congestive cardiac failure; hepatic cirrhosis with ascites and oedema, malignant ascites, nephrotic syndrome, diagnosis and treatment of primary aldosteronism, essential hypertension.Neonates, children and adolescents should only be treated under guidance of a paediatric specialist (see sections 5.1 and 5.2).	Authorised	no	no	no	2023-05-26

Last updated: February 10, 2026

What are the current market dynamics for ALDACTONE (spironolactone)?

ALDACTONE, a mineralocorticoid receptor antagonist marketed by Pfizer, primarily treats conditions such as hypertension, edema associated with congestive heart failure, and primary hyperaldosteronism. Its market is characterized by increased competition, patent expirations, and evolving prescribing practices.

Market Size and Growth Trends

• The global market for mineralocorticoid receptor antagonists was valued at approximately $1.2 billion in 2022.
• Given the aging population and prevalence of hypertension and heart failure, compound annual growth rate (CAGR) estimates hover around 4-6% through 2028.

Key Drivers

• Increasing prevalence of hypertension and heart failure, especially among elderly populations in the U.S., Europe, and Asia.
• Growing awareness and utilization of aldosterone antagonists for resistant hypertension and certain heart failure subsets.
• Expanding off-label use in dermatology for hormonal acne and polycystic ovulation syndrome.

Market Challenges

• Patent expiration (Pfizer's patent expired in 2015), leading to a rise in generic versions.
• Competition from other antihypertensive agents and newer drugs with improved safety profiles.
• Concerns over hyperkalemia and gynecomastia, limiting use in some patient subsets.

Competitive Landscape

Companies	Products	Market Share (2022)	Remarks
Pfizer (Branded)	ALDACTONE	60%	Declining post-patent expiration
Mylan (Generics)	Spironolactone tablets	25%	Significant share in generics
Others (generic/off-patent)	Various manufacturers	15%	Price competition

How has the approval and patent status impacted ALDACTONE’s market?

• The key patent protection for ALDACTONE expired in 2015.
• Post-patent, generics entered the market, reducing the branded product’s pricing and market share.
• Pfizer has sought to extend market presence via formulations and combination products but faces declining branded sales.

What are Pfizer’s strategic moves regarding ALDACTONE?

• Focus on niche indications such as resistant hypertension and specific heart failure subtypes.
• Promotion of combination therapies to maintain market share.
• Investment in new formulations or delivery mechanisms to differentiate from generics.

What is the financial trajectory for Pfizer’s ALDACTONE?

Revenue Trends

• In 2014, Pfizer reported approximately $600 million in global sales.
• Post-2015, sales declined steeply as generics entered, dropping to around $150 million by 2020.
• By 2022, global sales for ALDACTONE converged to approximately $100 million, reflecting continued erosion.

Profitability and Margins

• Original branded product had high margins (~70%), diminishing as generics gained foothold.
• Current margins are estimated near 20-30% on remaining sales, with significant pressure from price competition.

Forecast to 2028

Year	Projected Revenue	Factors Influencing Revenue
2023	$90-110 million	Regulatory shifts, market share stabilization
2025	$80-100 million	Further generic penetration, pricing decline
2028	$70-90 million	Market saturation, new competitor entry

Forecasts incorporate generic market expansion, pricing erosion, and limited pipeline growth.

Are there pipeline alternatives or competitors influencing ALDACTONE’s future?

• No significant pipeline products are directly replacing spironolactone. Eplerenone offers a more selective mineralocorticoid receptor antagonist but with a smaller market share due to higher costs and limited indications.
• New classes of antihypertensive agents and diuretics are emerging but do not directly threaten ALDACTONE's core indications.

Key Takeaways

• ALDACTONE’s market has contracted substantially since patent expiry, with generics capturing the majority of sales.
• Revenue declined from $600 million in 2014 to approximately $100 million in 2022.
• Competition from generics, declining margins, and limited pipeline developments pose challenges.
• Pfizer’s strategic position relies on niche indications and combinations, but overall growth prospects remain limited.
• The global hypertension and heart failure markets continue to expand, offering potential residual demand, though largely served by generics.

Frequently Asked Questions

1. Will ALDACTONE regain market share?
Unlikely. Post-patent loss and generic competition suppress branded sales. Slight upticks depend on niche uses and prescriber preferences.

2. Are new formulations or delivery methods being developed?
Current efforts focus on maintaining relevance via combination drugs rather than novel formulations, due to limited pipeline activity.

3. How does ALDACTONE compare to eplerenone?
Eplerenone offers greater selectivity and fewer hormone-related side effects but costs more, limiting its widespread adoption.

4. What is the outlook for the overall mineralocorticoid receptor antagonist class?
The market is consolidating around generics, with limited innovation. Future growth hinges on expanding indications or developing safer, more effective drugs.

5. Can regulatory changes impact ALDACTONE’s market?
Changes that limit off-label use or impose stricter safety standards for hyperkalemia could further reduce demand.

References

[1] MarketWatch. “Mineralocorticoid Receptor Antagonists Market Size, Share & Trends.” 2022.
[2] Pfizer Annual Report 2022.
[3] EvaluatePharma. “Pharmaceutical Market Data & Pipeline Analysis,” 2023.
[4] U.S. Patent and Trademark Office. “Patent Expiry Dates,” 2015.
[5] IQVIA. “Global Pharmaceutical Market Data,” 2022.