SPIRONOLACTONE - Generic Drug Details

What are the generic drug sources for spironolactone and what is the scope of patent protection?

Spironolactone is the generic ingredient in three branded drugs marketed by Cmp Dev Llc, Amneal, Hetero Labs Ltd Iii, Pfizer, Accord Hlthcare, Actavis Elizabeth, Amneal Pharms, Annora Pharma, Ascot, Aurobindo Pharma, Chartwell Rx, Graviti Pharms, Ivax Pharms, Jubilant Generics, Lederle, Mutual Pharm, Mylan, Oxford Pharms, Pharmobedient, Purepac Pharm, Sun Pharm Industries, Superpharm, Upsher Smith, Vangard, Warner Chilcott, Watson Labs, and Zydus Pharms, and is included in twenty-nine NDAs. There are eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Spironolactone has four patent family members in four countries.

There are sixteen drug master file entries for spironolactone. Forty-one suppliers are listed for this compound.

Summary for SPIRONOLACTONE

International Patents:	4
US Patents:	8
Tradenames:	3
Applicants:	27
NDAs:	29
Drug Master File Entries:	16
Finished Product Suppliers / Packagers:	41
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	285
Patent Applications:	7,087
Drug Prices:	Drug price trends for SPIRONOLACTONE
Drug Sales Revenues:	Drug sales revenues for SPIRONOLACTONE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for SPIRONOLACTONE
What excipients (inactive ingredients) are in SPIRONOLACTONE?	SPIRONOLACTONE excipients list
DailyMed Link:	SPIRONOLACTONE at DailyMed

See drug prices for SPIRONOLACTONE

See drug sales revenues for SPIRONOLACTONE

Recent Clinical Trials for SPIRONOLACTONE

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

Sponsor	Phase
Martin Rohacek	PHASE4
Ifakara Health Institute (IHI)	PHASE4
University of Pittsburgh Medical Center	PHASE2

See all SPIRONOLACTONE clinical trials

Pharmacology for SPIRONOLACTONE

Drug Class	Aldosterone Antagonist
Mechanism of Action	Aldosterone Antagonists

Medical Subject Heading (MeSH) Categories for SPIRONOLACTONE

Diuretics

Mineralocorticoid Receptor Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for SPIRONOLACTONE

C03DA	Aldosterone antagonists
C03D	ALDOSTERONE ANTAGONISTS AND OTHER POTASSIUM-SPARING AGENTS
C03	DIURETICS
C	Cardiovascular system

Paragraph IV (Patent) Challenges for SPIRONOLACTONE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
CAROSPIR	Oral Suspension	spironolactone	25 mg/5 mL	209478	1	2020-12-31

US Patents and Regulatory Information for SPIRONOLACTONE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Zydus Pharms	SPIRONOLACTONE	spironolactone	TABLET;ORAL	205936-003	Jul 18, 2018	AB	RX	No	No
Watson Labs	SPIRONOLACTONE	spironolactone	TABLET;ORAL	087078-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Pfizer	ALDACTONE	spironolactone	TABLET;ORAL	012151-009	Dec 30, 1983	AB	RX	Yes	No
Vangard	SPIRONOLACTONE	spironolactone	TABLET;ORAL	087648-001	Feb 1, 1982		DISCN	No	No
Pfizer	ALDACTONE	spironolactone	TABLET;ORAL	012151-010	Dec 30, 1983	AB	RX	Yes	Yes

EU/EMA Drug Approvals for SPIRONOLACTONE

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

International Patents for SPIRONOLACTONE

Country	Patent Number	Title	Estimated Expiration
Morocco	43132	COMPOSITIONS AQUEUSES DE SPIRONOLACTONE
Canada	3003028
Canada	3003028	COMPOSITIONS AQUEUSES DE SPIRONOLACTONE (SPIRONOLACTONE AQUEOUS COMPOSITIONS)
World Intellectual Property Organization (WIPO)	2017075463
Morocco	43132

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: Spironolactone

Last updated: July 27, 2025

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Introduction

Spironolactone, a potassium-sparing diuretic and aldosterone antagonist, has been a cornerstone in the treatment of conditions such as heart failure, hypertension, and hyperaldosteronism since its approval in the 1960s. Over the decades, its pharmacological profile and applications have expanded, influencing market dynamics and financial trajectories across regions. This analysis examines the evolving landscape of spironolactone, driven by clinical needs, regulatory shifts, patent considerations, and emerging competitive forces, providing insights for stakeholders seeking strategic positioning.

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Historical Market Context and Sales Trajectory

Initially introduced as a diuretic for edema and hypertension, spironolactone’s widespread adoption stemmed from its unique mechanism of action—antagonism of aldosterone receptors—addressing conditions linked to endocrine disturbances. By the early 2000s, sales peaked in mature markets like North America and Europe, buoyed by the drug’s proven efficacy and relatively low cost.

However, patent expirations and generic competition precipitated a significant decline in pricing and sales volume. According to IQVIA data, global sales of spironolactone peaked around US$1.2 billion in 2010, but have since plateaued or declined in some regions due to generic erosion, reaching approximately US$700 million in 2022 [1].

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Market Drivers and Influencing Factors

1. Clinical Expansion and New Therapeutic Indications

The versatility of spironolactone has spurred exploration into novel indications such as resistant hypertension, heart failure with preserved ejection fraction (HFpEF), acne, and hirsutism. The landmark RALES trial (1999) demonstrated spironolactone’s survival benefit in severe heart failure, fueling clinical guidelines’ adoption and expanding its market reach [2].

In recent years, the drug has gained renewed interest as an adjunct in managing resistant hypertension, especially in combination therapies. The recognition of mineralocorticoid receptor overactivity in metabolic syndromes further broadens its potential indications, although regulatory approvals remain limited outside traditional uses.

2. Patent and Generic Landscape

The original patents for spironolactone expired in the early 2000s, leading to proliferation of generic formulations. This significantly reduced pricing pressure but constrained innovation-driven revenue growth. Nevertheless, market consolidation and strategic licensing agreements continue to influence availability, especially in emerging markets where drug affordability remains a priority.

3. Regulatory Environment and Market Access

Stringent regulatory pathways influence market dynamics. The FDA’s reevaluation of safety profiles concerning hyperkalemia and endocrine side effects has impacted prescribing practices, albeit not substantially limiting market access. Conversely, approval for new formulations or delivery mechanisms could revitalize the product’s market trajectory.

4. Competitive Landscape

While spironolactone faces competition from newer mineralocorticoid receptor antagonists like eplerenone and finerenone, these agents typically come at higher costs and with different safety profiles, influencing their market penetration. Additionally, the rise of alternative therapies targeting related pathways impacts the relative market position of spironolactone.

5. Market Trends and Patient Demographics

Aging populations and rising prevalence of hypertension and heart failure sustain demand. However, concerns regarding side effects such as hyperkalemia, gynecomastia, and hormonal effects necessitate careful patient selection, influencing prescribing patterns.

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Financial Trajectory and Future Outlook

1. Short-term Trends (2023-2025)

The immediate future indicates modest growth driven by expanding indications, particularly in resistant hypertension and certain dermatological conditions. Market penetration in emerging economies presents significant opportunities, bolstered by governmental and institutional initiatives to improve access to affordable medications.

2. Mid to Long-term Projections (2026-2030)

Innovations in formulation, such as controlled-release versions, could reduce adverse effects, broadening the patient base. The development of combination therapies incorporating spironolactone suggests potential for metabolic syndrome management. However, the emergence of superior agents with fewer side effects may limit the growth of traditional spironolactone sales unless competitive pricing and novel formulations are introduced.

3. Impact of Regulatory Changes and Patents

The absence of patent protection for spironolactone limits blockbuster potential but sustains steady revenues as a low-cost generic. The entry of biosimilars is less relevant; however, patenting new delivery systems or new uses might open incremental licensing opportunities.

4. Market Risks and Challenges

Key risks include safety concerns triggering regulatory restrictions, market saturation in developed economies, and competition from newer agents. Additionally, the global focus on personalized medicine emphasizes the importance of targeted therapy, possibly favoring specialty drugs over broad-spectrum diuretics.

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Strategic Opportunities and Considerations

• Development of Enhanced Formulations: Innovating formulations that mitigate side effects could expand tolerability and market share.
• Geographic Expansion: Targeting emerging markets with high disease burdens and limited access to branded therapies can offset saturation in mature markets.
• Repurposing and New Indications: Pursuing clinical trials for additional indications such as metabolic or dermatological conditions offers revenue diversification.
• Regulatory Advocacy: Engaging with regulatory bodies to streamline approval for new formulations and indications may accelerate adoption.

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Key Takeaways

• Spironolactone remains a vital generic drug with a stable but mature market primarily driven by its established efficacy in heart failure and hypertension.
• Patent expirations and generic competition have suppressed profit margins, emphasizing the importance of innovation in formulation and new indications.
• Expanding clinical applications and geographic penetration in emerging markets present opportunities for growth.
• Safety concerns influence prescribing patterns, but advances in formulation can mitigate adverse effects and extend market viability.
• The financial trajectory is expected to be modestly positive in the short to medium term, contingent upon strategic developments and market conditions.

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FAQs

1. What are the primary markets driving spironolactone sales?
The U.S., Europe, and Japan historically lead sales, with emerging markets such as India, China, and Latin America showing increasing demand driven by prevalent hypertension and heart failure rates.

2. How does the patent expiration impact spironolactone’s profitability?
Patent expiry facilitated generic manufacturing, sharply reducing prices but stabilizing overall demand due to the drug’s low cost and widespread clinical use.

3. Are there recent regulatory concerns associated with spironolactone?
Regulatory authorities have highlighted risks like hyperkalemia and endocrine effects, but these concerns have not led to significant label restrictions, although they influence prescribing guidelines.

4. What emerging therapeutic areas could boost spironolactone’s market?
Resistant hypertension, heart failure with preserved ejection fraction, and dermatological conditions such as acne and hirsutism are promising new areas.

5. How does competition from newer drugs affect spironolactone’s market?
While agents like eplerenone and finerenone offer improved selectivity and safety profiles, their higher costs limit widespread use compared to spironolactone’s affordability.

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References

[1] IQVIA Data, 2022. Global sales figures for spironolactone.
[2] Pitt, B., et al. (1999). The Randomized Aldactone Evaluation Study (RALES). Lancet, 354(9194), 675-672.