Chlorothiazide sodium - Generic Drug Details

What are the generic sources for chlorothiazide sodium and what is the scope of freedom to operate?

Chlorothiazide sodium is the generic ingredient in two branded drugs marketed by Am Regent, Fresenius Kabi Usa, Gland, Rk Pharma, Sagent Pharms Inc, Sun Pharm, and Rising, and is included in seven NDAs. Additional information is available in the individual branded drug profile pages.

There is one drug master file entry for chlorothiazide sodium. Five suppliers are listed for this compound.

Summary for chlorothiazide sodium

US Patents:	0
Tradenames:	2
Applicants:	7
NDAs:	7
Drug Master File Entries:	1
Finished Product Suppliers / Packagers:	5
Raw Ingredient (Bulk) Api Vendors:	13
Clinical Trials:	4
Patent Applications:	235
What excipients (inactive ingredients) are in chlorothiazide sodium?	chlorothiazide sodium excipients list
DailyMed Link:	chlorothiazide sodium at DailyMed

Recent Clinical Trials for chlorothiazide sodium

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

Sponsor	Phase
Vanderbilt University	Phase 4
Yale University	Phase 1
National Heart, Lung, and Blood Institute (NHLBI)	Phase 1

See all chlorothiazide sodium clinical trials

Pharmacology for chlorothiazide sodium

Drug Class	Thiazide Diuretic
Physiological Effect	Increased Diuresis

Anatomical Therapeutic Chemical (ATC) Classes for chlorothiazide sodium

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

US Patents and Regulatory Information for chlorothiazide sodium

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sun Pharm	CHLOROTHIAZIDE SODIUM	chlorothiazide sodium	INJECTABLE;INJECTION	091546-001	Jul 26, 2011	AP	RX	No	No
Fresenius Kabi Usa	CHLOROTHIAZIDE SODIUM	chlorothiazide sodium	INJECTABLE;INJECTION	090896-001	Oct 16, 2009	AP	RX	No	No
Gland	CHLOROTHIAZIDE SODIUM	chlorothiazide sodium	INJECTABLE;INJECTION	218630-001	Oct 3, 2024	AP	RX	No	No
Am Regent	CHLOROTHIAZIDE SODIUM	chlorothiazide sodium	INJECTABLE;INJECTION	202561-001	Apr 22, 2013	AP	RX	No	No
Rk Pharma	CHLOROTHIAZIDE SODIUM	chlorothiazide sodium	INJECTABLE;INJECTION	202493-001	Jun 18, 2014		DISCN	No	No

Market Dynamics and Financial Trajectory for CHLOROTHIAZIDE SODIUM

Last updated: July 30, 2025

Introduction

Chlorothiazide sodium, a longstanding diuretic primarily used in managing hypertension and edema, remains a significant component in cardiovascular therapeutics. Despite its age, the drug continues to influence market landscapes due to evolving clinical guidelines, generic accessibility, and emerging combination therapies. This analysis explores the intricacies of its market dynamics and forecasts its financial trajectory in an increasingly competitive pharmaceutical environment.

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Historical Context and Therapeutic Profile

Chlorothiazide sodium, a synthetic thiazide diuretic, was first introduced in the mid-20th century. It functions by inhibiting sodium reabsorption in the distal convoluted tubule, reducing blood volume, and lowering blood pressure (BP). Its long-standing efficacy and well-understood pharmacokinetics underpin its sustained clinical relevance. However, the advent of newer antihypertensive agents and fixed-dose combinations has shaped its current market positioning.

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Current Market Landscape

Global Market Size and Trends

The global diuretic market was valued at approximately USD 3.2 billion in 2021 and is projected to grow at a compound annual growth rate (CAGR) of around 4.2% through 2027 [1]. Chlorothiazide sodium remains a core product within this sphere due to its cost-effectiveness and wide availability, especially in developing regions.

Key Market Segments

• Generic Drugs: The dominant segment—generics account for over 85% of the diuretic market. Chlorothiazide sodium's patent expiry in several territories has catalyzed widespread generic manufacturing.

• Prescription Patterns: Despite competition from other thiazides like hydrochlorothiazide and chlorthalidone, chlorothiazide sodium retains a niche, primarily in specific institutional and developing health systems.

• Combination Therapy: Increasing use of antihypertensive combinations leverages chlorothiazide sodium as part of fixed-dose regimes, influencing its market share.

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Market Drivers and Challenges

Drivers

1. Cost-Effectiveness: Its low cost sustains demand in price-sensitive markets, especially in Asia, Africa, and Latin America.

2. Established Efficacy: Decades of clinical use provide confidence among clinicians, especially in resource-limited settings.

3. Regulatory Approvals: Regulatory acceptance of generics enhances accessibility and drives volume sales.

4. Chronic Disease Prevalence: Rising hypertension prevalence globally sustains underlying demand.

Challenges

1. Emerging Therapeutics: Newer options, such as indapamide and chlorthalidone, offer improved safety profiles or efficacy, limiting chlorothiazide sodium’s growth.

2. Clinical Preference Shift: Guidelines increasingly favor certain agents over chlorothiazide sodium due to side effect profiles, notably electrolyte imbalances.

3. Market Saturation: Many mature markets are highly saturated, constraining expansion opportunities.

4. Regulatory and Patent Issues: Although patent expiry fosters generics, patent challenges and regulatory hurdles in specific regions can impact supply chains.

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Competitive Landscape

The market features a mix of major generics manufacturers, including Teva, Mylan (now part of Viatris), and Sun Pharmaceutical. Competition is intensified through product modifications, out-of-pocket pricing strategies, and strategic alliances with healthcare providers. There is also a trend towards combination drugs incorporating chlorothiazide sodium, which, while benefiting patient adherence, dilutes market share for standalone formulations.

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Regulatory and Policy Impact

Regulatory bodies such as the FDA and EMA widely approve chlorothiazide sodium as a generic diuretic. However, regulations promoting newer agents or specific formulations influence market stability. Policies favoring cost-effective, established medications bolster chlorothiazide sodium's market presence but may also accelerate substitution with newer therapies.

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Future Financial Trajectory

Forecast Overview

Based on current trends and the broader cardiovascular medication landscape, the chlorothiazide sodium market is expected to experience modest growth, aligning with the overall diuretic segment's CAGR of approximately 4.2% through 2027 [1].

Key Factors Influencing Trajectory

• Expanding Use in Developing Nations: Increased healthcare infrastructure and hypertension awareness will sustain demand.

• Generics Market Stability: Continued availability of low-cost generics ensures steady revenue streams, although margins may decline due to pricing pressures.

• Emerging Combination Therapies: Although these may reduce the need for standalone chlorothiazide sodium products, they also open avenues for co-marketing and strategic alliances.

• Innovation and Reformulation: Minimal innovation is expected given the drug's age, limiting substantial revenue growth.

Potential Revenue Projections

Assuming global sales of approximately USD 120 million in 2022, with a conservative CAGR of 3-4%, revenues could approach USD 140-150 million by 2027, primarily driven by emerging markets.

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Strategic Considerations

Manufacturers aiming to capitalize on chlorothiazide sodium should focus on cost leadership and strategic partnerships facilitating access in emerging economies. Additionally, formulations compatible with combination therapies and innovative delivery mechanisms could enhance competitiveness. Meanwhile, R&D efforts are more pragmatically directed toward niche markets or reformulations rather than new molecular entities.

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Conclusion

Chlorothiazide sodium remains a cornerstone diuretic owing to its proven efficacy, affordability, and regulatory acceptance. Its market distribution is predominantly shaped by generic manufacturing, with growth driven by emerging markets and chronic disease prevalence. While face-to-face with emerging therapies and market saturation, it continues to demonstrate a resilient financial trajectory. Strategic focus on cost efficiencies and emerging markets will be vital for stakeholders aiming to optimize returns amid evolving healthcare landscapes.

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Key Takeaways

• The global chlorothiazide sodium market is characterized by steady, moderate growth predominantly supported by generics and emerging markets.

• Cost advantages and established clinical efficacy underpin continuous demand, especially in resource-constrained settings.

• Competition from newer diuretics and combination therapies presents challenges, necessitating strategic positioning for manufacturers.

• Future revenue growth hinges on market expansion in developing countries and niche formulation innovations.

• Stakeholders should prioritize cost optimization, regional market penetration, and strategic alliances rather than significant R&D investments for this mature asset.

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Frequently Asked Questions (FAQs)

Q1: How does chlorothiazide sodium compare to other thiazide diuretics regarding efficacy and safety?

A: Chlorothiazide sodium offers comparable antihypertensive efficacy to other thiazides like hydrochlorothiazide and chlorthalidone. However, newer agents may have improved safety profiles or longer durations of action, influencing clinical preference, especially in developed markets.

Q2: What are the main markets driving the demand for chlorothiazide sodium?

A: The primary markets include low- and middle-income countries in Asia, Africa, and Latin America, where affordability and established efficacy sustain demand.

Q3: Are there significant patent or regulatory barriers affecting chlorothiazide sodium?

A: As a generic, chlorothiazide sodium benefits from patent expirations in many regions; however, regulatory challenges can vary, impacting manufacturing and distribution.

Q4: What strategic moves can manufacturers leverage to maintain competitiveness?

A: Focus on cost leadership, expanding access in emerging markets, developing combination formulations, and securing strategic partnerships are essential strategies.

Q5: What is the outlook for chlorothiazide sodium in the context of emerging combination therapies?

A: While standalone formulations may decline, chlorothiazide sodium can be incorporated into fixed-dose combinations, potentially stabilizing or expanding its market presence through improved patient adherence and simplified regimens.

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References

[1] Market Research Future, "Diuretics Market Size and Forecast," 2022.