HYDROCHLOROTHIAZIDE; SPIRONOLACTONE - Generic Drug Details

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

Hydrochlorothiazide; spironolactone is the generic ingredient in three branded drugs marketed by Pfizer, Ascot, Chartwell Rx, Mutual Pharm, Mylan, Purepac Pharm, Sun Pharm Industries, Superpharm, Watson Labs, Ivax Pharms, Lederle, Parke Davis, Upsher Smith, Usl Pharma, and Vangard, and is included in eighteen NDAs. Additional information is available in the individual branded drug profile pages.

Five suppliers are listed for this compound.

Summary for HYDROCHLOROTHIAZIDE; SPIRONOLACTONE

US Patents:	0
Tradenames:	3
Applicants:	15
NDAs:	18
Finished Product Suppliers / Packagers:	5
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	11
DailyMed Link:	HYDROCHLOROTHIAZIDE; SPIRONOLACTONE at DailyMed

Recent Clinical Trials for HYDROCHLOROTHIAZIDE; SPIRONOLACTONE

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

Sponsor	Phase
Dutch Kidney Foundation	NA
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)	NA
Pfizer	PHASE1

See all HYDROCHLOROTHIAZIDE; SPIRONOLACTONE clinical trials

Pharmacology for HYDROCHLOROTHIAZIDE; SPIRONOLACTONE

Drug Class	Aldosterone Antagonist Thiazide Diuretic
Mechanism of Action	Aldosterone Antagonists
Physiological Effect	Increased Diuresis

Anatomical Therapeutic Chemical (ATC) Classes for HYDROCHLOROTHIAZIDE; SPIRONOLACTONE

C03AA	Thiazides, plain
C03A	LOW-CEILING DIURETICS, THIAZIDES
C03	DIURETICS
C	Cardiovascular system

C03AA	Thiazides, plain
C03A	LOW-CEILING DIURETICS, THIAZIDES
C03	DIURETICS
C	Cardiovascular system

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

US Patents and Regulatory Information for HYDROCHLOROTHIAZIDE; SPIRONOLACTONE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mylan	SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; spironolactone	TABLET;ORAL	086513-001	Approved Prior to Jan 1, 1982	AB	RX	No	No
Pfizer	ALDACTAZIDE	hydrochlorothiazide; spironolactone	TABLET;ORAL	012616-005	Dec 30, 1982		DISCN	Yes	No
Superpharm	SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; spironolactone	TABLET;ORAL	089137-001	Aug 26, 1985		DISCN	No	No
Ascot	SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; spironolactone	TABLET;ORAL	088025-001	Nov 23, 1984		DISCN	No	No
Parke Davis	SPIRONOLACTONE W/ HYDROCHLOROTHIAZIDE	hydrochlorothiazide; spironolactone	TABLET;ORAL	087948-001	Feb 22, 1983		DISCN	No	No
Lederle	SPIRONOLACTONE W/ HYDROCHLOROTHIAZIDE	hydrochlorothiazide; spironolactone	TABLET;ORAL	087511-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Usl Pharma	SPIRONOLACTONE W/ HYDROCHLOROTHIAZIDE	hydrochlorothiazide; spironolactone	TABLET;ORAL	087651-001	Approved Prior to Jan 1, 1982		DISCN	No	No

Market Dynamics and Financial Trajectory for Hydrochlorothiazide and Spironolactone

Last updated: July 30, 2025

Introduction

Hydrochlorothiazide (HCTZ) and spironolactone are two prominent diuretic medications with distinct indications and market trajectories. Hydrochlorothiazide, a thiazide diuretic, primarily treats hypertension and edema, while spironolactone, a potassium-sparing agent, addresses conditions such as heart failure, hypertension, and hormonal disorders like hyperaldosteronism. This analysis examines the evolving market landscape, regulatory influences, and financial prospects shaping these drugs' trajectories within the global pharmaceutical industry.

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Market Overview

Hydrochlorothiazide: Market Size and Trends

Hydrochlorothiazide maintains a critical role in the antihypertensive therapy landscape, owing to its efficacy, affordability, and extensive generic availability. The global market for HCTZ was valued at approximately USD 1.4 billion in 2021, with steady growth driven by the rising prevalence of hypertension — estimated to affect over 1.3 billion people worldwide[1].

Despite the drug’s longstanding presence, the market faces evolving dynamics. Its patent expiry in multiple territories has intensified generic competition, exerting downward pressure on prices and profit margins. Moreover, clinical guidelines increasingly favor combination therapies (e.g., HCTZ with ACE inhibitors), reducing standalone prescriptions.

Spironolactone: Market Expansion and Innovation

Spironolactone’s market is comparatively dynamic, buoyed by its versatile indications—from heart failure to hormonal therapy in conditions like hirsutism and certain gynecomastias. The drug's revenue has been buoyant, with its global market estimated at USD 600 million in 2021[2], driven by expanding use cases and innovational formulations.

Recent developments have included the development of novel mineralocorticoid receptor antagonists (MRAs) with improved safety profiles, such as eplerenone and the promising non-steroidal MRA finerenone. These innovations threaten to cannibalize traditional spironolactone sales but also open new therapeutic avenues.

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Market Drivers

1. Epidemiological Trends

The persistent rise in hypertension and heart failure prevalence globally fuels demand for both drugs. According to the WHO, the number of adults living with hypertension is projected to reach 1.6 billion by 2025[3], underpinning sustained drug utilization.

2. Regulatory and Reimbursement Policies

Regulatory bodies like the FDA and EMA have recently intensified requirements for demonstrating safety, efficacy, and quality, particularly for long-term therapies such as diuretics. The approval of biosimilars and generics has lowered costs, expanding access but squeezing profit margins for branded manufacturers.

Reimbursement policies influence prescribing trends, with payers favoring cost-effective generic options, hastening the commoditization of HCTZ.

3. Competition and Innovation

Generic proliferation diminishes revenues for branded drugs like hydrochlorothiazide. Conversely, spironolactone benefits from a diversified IP landscape, though patent cliffs are imminent for some formulations. The rise of ENaC inhibitors and non-steroidal MRAs introduces competitive pressures but also opportunities for market expansion.

4. Clinical Practice Guidelines

Guidelines increasingly endorse combination regimens for hypertension, with HCTZ often relegated from monotherapy to adjunct use, negatively impacting sales. Spironolactone’s broader indication spectrum supports sustained or increasing demand.

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Financial Trajectory and Forecasts

Hydrochlorothiazide

Current trends suggest a plateau or modest decline in HCTZ revenues over the next five years, driven by market saturation and substitution by newer agents and combinations. Global sales are projected to decline at a Compound Annual Growth Rate (CAGR) of approximately 1-2% through 2027[4]. The commoditization of HCTZ warrants strategic shifts toward formulation innovation or combination therapy development.

Spironolactone

Spironolactone’s revenue trajectory remains relatively stable, with potential for growth driven by expanding indications and formulations. The emergence of novel MRAs with improved safety profiles could either augment or displace spironolactone sales. Overall, the market is forecasted at a CAGR of 3-4% through the next five years, contingent on regulatory approvals and clinical adoption of innovations[5].

Key Financial Considerations

• Pricing Pressures: Widespread generic availability suppresses unit prices, challenging margins.
• Patent Expirations: Upcoming patent cliffs—particularly for spironolactone in certain markets—may accelerate generic entry.
• Market Penetration: Increasing adoption of combination therapies enhances sales opportunities but requires strategic partnerships and formulation adaptation.

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Regulatory and Competitive Influences

Regulatory Environment

Regulators emphasize biosimilar pathways and combination product approvals, which could influence market dynamics. The FDA’s recent approval of certain generic formulations with enhanced bioequivalence standards favors commoditization, especially for HCTZ.

Competitive Landscape

Generic manufacturers dominate the hydrochlorothiazide market, with some branded hospitals and specialty pharmacies focusing on quality differentiation. For spironolactone, a mix of traditional generics and emerging non-steroidal MRAs provides alternative options, potentially encroaching on traditional markets.

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Opportunities and Challenges

Opportunities

• Formulation Innovation: Developing combination products (e.g., HCTZ with antihypertensives) to sustain sales.
• Expansion into Emerging Markets: Scaling distribution in regions with rising hypertension prevalence.
• Development of New Indications: For spironolactone, exploring uses in dermatology and endocrinology could unlock additional revenue streams.

Challenges

• Pricing Competition: Widespread generic presence leads to compressed margins.
• Regulatory Barriers: Stringent approval processes for new formulations or indications.
• Market Saturation: Limits growth potential, especially for HCTZ.

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Conclusion

Hydrochlorothiazide and spironolactone exhibit distinct market trajectories shaped by epidemiological trends, regulatory policies, and competitive innovations. Hydrochlorothiazide faces stagnation and potential decline owing to generic saturation and evolving treatment paradigms. Conversely, spironolactone’s broader application scope and recent advancements position it for moderate growth, though upcoming patent expiries and competition from newer agents present ongoing challenges. Strategic adaptation—through formulation innovation, market expansion, and indication diversification—is vital for sustaining profitability within these mature drug classes.

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Key Takeaways

• Hydrochlorothiazide’s market is mature, with limited growth prospects due to generic competition and changing clinical guidelines.
• Spironolactone maintains stable demand, with potential growth driven by expanded indications and newer MRAs.
• Market dynamics hinge on epidemiological trends, regulatory approvals, and technological innovations.
• Diversification into combination therapies and emerging markets offers growth opportunities despite pricing pressures.
• Companies must monitor patent cliffs, regulatory shifts, and competitive innovations to optimize financial outcomes.

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FAQs

1. What factors most significantly influence the market decline of hydrochlorothiazide?
The primary factors include patent expirations, increasing use of combination therapies reducing standalone prescriptions, and aggressive generic competition leading to price erosion.

2. How might emerging mineralocorticoid receptor antagonists impact spironolactone sales?
Newer MRAs like finerenone offer improved safety profiles (e.g., reduced hyperkalemia risk), potentially cannibalizing spironolactone’s market share but also creating new therapeutic segments.

3. What strategies can pharmaceutical companies employ to sustain revenues from hydrochlorothiazide?
Developing fixed-dose combination products, targeting emerging markets, and creating innovative formulations can help offset market saturation and pricing pressures.

4. Are there specific regulatory hurdles unique to these drugs?
Yes. For HCTZ, bioequivalence standards for generics and approval of combination products are critical. For spironolactone, safety data for new indications and formulations influence approval timelines.

5. What is the future outlook for these drugs in the context of personalized medicine?
Personalized treatment strategies and pharmacogenomics may influence prescribing patterns, with tailored therapies potentially improving outcomes but challenging standard formulations’ market dominance.

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Sources:

1. World Health Organization. Hypertension Fact Sheet. 2021
2. Grand View Research. Spironolactone Market Analysis. 2022
3. WHO. Global hypertension prevalence estimates, 2021
4. MarketWatch. Hydrochlorothiazide Global Market Size & Forecast. 2022
5. Fortune Business Insights. Mineralocorticoid Receptor Antagonists Market. 2022

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Disclaimer: The market data and forecasts are subject to change based on regulatory, technological, and epidemiological developments.