Chlorothiazide - Generic Drug Details

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

Chlorothiazide is the generic ingredient in eleven branded drugs marketed by Salix Pharms, Abc Holding, Hikma Intl Pharms, Lederle, Pharmobedient, Sandoz, Watson Labs, Rising, Am Regent, Fresenius Kabi Usa, Gland, Rk Pharma, Sagent Pharms Inc, Sun Pharm, Merck, Par Pharm, and Hikma, and is included in thirty NDAs. Additional information is available in the individual branded drug profile pages.

There are forty-two drug master file entries for chlorothiazide. One supplier is listed for this compound.

Summary for chlorothiazide

US Patents:	0
Tradenames:	11
Applicants:	17
NDAs:	30
Drug Master File Entries:	42
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	8
Patent Applications:	7,109
Drug Prices:	Drug price trends for chlorothiazide
What excipients (inactive ingredients) are in chlorothiazide?	chlorothiazide excipients list
DailyMed Link:	chlorothiazide at DailyMed

See drug prices for chlorothiazide

Recent Clinical Trials for chlorothiazide

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

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

See all chlorothiazide clinical trials

Pharmacology for chlorothiazide

Drug Class	Thiazide Diuretic
Physiological Effect	Increased Diuresis

Medical Subject Heading (MeSH) Categories for chlorothiazide

Antihypertensive Agents

Diuretics

Sodium Chloride Symporter Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for chlorothiazide

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

US Patents and Regulatory Information for chlorothiazide

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Lederle	CHLOROTHIAZIDE	chlorothiazide	TABLET;ORAL	086938-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Rising	DIURIL	chlorothiazide sodium	INJECTABLE;INJECTION	011145-005	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Merck	DIUPRES-250	chlorothiazide; reserpine	TABLET;ORAL	011635-003	Aug 26, 1987		DISCN	No	No
Abc Holding	CHLOROTHIAZIDE	chlorothiazide	TABLET;ORAL	085569-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Hikma	CHLOROTHIAZIDE AND RESERPINE	chlorothiazide; reserpine	TABLET;ORAL	088557-001	Dec 22, 1983		DISCN	No	No
Sandoz	CHLOROTHIAZIDE	chlorothiazide	TABLET;ORAL	085485-001	Approved Prior to Jan 1, 1982		DISCN	No	No

Market Dynamics and Financial Trajectory for Chlorothiazide

Last updated: July 28, 2025

Introduction

Chlorothiazide, a thiazide diuretic first introduced in the 1950s, remains a cornerstone medication in managing hypertension and edema. Despite its age, it continues to influence global pharmaceutical markets due to its cost-effectiveness, established efficacy, and role within combination therapies. The evolving landscape of disease management, drug patent statuses, and regulatory pathways shape its market dynamics and financial trajectory, necessitating a detailed exploration for stakeholders.

Historical Context and Patent Landscape

Chlorothiazide was among the first thiazide diuretics approved by the U.S. Food and Drug Administration (FDA) in the 1950s. Its patent expiration in the 1980s transformed it into a generic medication, leading to widespread availability and low-cost alternatives. The commoditization of chlorothiazide set the stage for a highly competitive market characterized largely by generic producers, limiting considerable revenue potential but ensuring broad accessibility.

Market Drivers

Prevalence of Hypertension and Edema

The global burden of hypertension affects over 1 billion individuals, with many managed through affordable diuretics such as chlorothiazide. Market demand is sustained by aging populations, rising obesity rates, and increased awareness, particularly in developing economies where low-cost treatment options are prioritized.

Cost-Effectiveness and Generic Competition

As a mature product with no patent protection, chlorothiazide's market relies predominantly on generic manufacturing. Its low price point attracts healthcare systems aiming to curb escalating drug expenditures, especially in resource-limited settings. This dynamic sustains steady demand but constrains pricing power and profit margins.

Regulatory and Prescribing Trends

Recent shifts favor combination therapy and newer antihypertensives with improved side effect profiles. Nonetheless, chlorothiazide remains recommended in treatment guidelines and is often used in conjunction with ACE inhibitors, ARBs, or calcium channel blockers, cementing its role in multi-drug regimens.

Market Challenges

Emergence of Newer Diuretics

Thiazide-like diuretics such as indapamide and chlorthalidone offer longer duration and potentially superior blood pressure control. The clinical preference shifting toward these agents may marginalize chlorothiazide's market share.

Regulatory Limitations

Some regions have restricted chlorothiazide use due to concerns about its metabolic side effects and less favorable pharmacokinetics compared to newer agents. This regulatory landscape influences prescribing practices and competitive positioning.

Patent and Exclusivity Constraints

Although patent expiry in the 1980s limits revenue potential, ongoing challenges include competition from branded formulations, fixed-dose combinations, and reformulations that might obscure generic equivalents' market share.

Financial Trajectory and Forecasts

Revenue Stability

Given its status as a generic drug, chlorothiazide's market revenue has been relatively stable, primarily driven by volume rather than price. Globally, the drug generates hundreds of millions of dollars annually, with market size estimates around US$200–300 million as of recent years (e.g., IQVIA data).

Growth Opportunities

The primary growth derives from expanding access in emerging markets. As healthcare infrastructure improves, chlorothiazide's affordability positions it favorably against costly newer agents, sustaining steady demand.

Market Saturation and Decline

In developed countries, its use is plateauing due to clinical preferences. The rise of newer agents with improved safety profiles and evidence may lead to gradual substitution, potentially reducing chlorothiazide's market share over the next decade.

Innovations and Formulation Strategies

Limited innovation exists given its age; however, fixed-dose combinations involving chlorothiazide may extend its market viability, especially if regulatory approvals expedite their entry and adoption.

Global and Regional Market Perspectives

• United States: Chlorothiazide’s use has declined, replaced increasingly by chlorthalidone and indapamide, though it remains prescribed in specific clinical settings.

• Europe: Similar trends are observed, with regulatory bodies favoring newer agents for safety considerations.

• Emerging Markets: The greatest growth potential lies here, fueled by demand for affordable antihypertensive therapies, with countries like India and China displaying increased generic adoption.

Strategic Implications for Stakeholders

Pharmaceutical companies engaged in chlorothiazide production should focus on cost-efficient manufacturing and strategic marketing to maintain market share. Emphasis on large-volume sales and partnerships with healthcare systems can offset declining margins. Additionally, exploring fixed-dose combinations or niche therapeutic applications could foster continued revenue streams.

Conclusion

The market landscape for chlorothiazide reflects the characteristics of a mature, low-margin generic drug. While global demand persists, particularly in resource-limited regions, evolving clinical preferences and regulatory environments challenge its long-term growth. Stakeholders should align strategies toward maximizing volume, embracing innovation in formulations, and targeting emerging markets to sustain financial viability.

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Key Takeaways

• Chlorothiazide continues to play a vital role in hypertension management, especially in emerging markets due to its affordability.
• Patent expiry and generic competition limit revenue growth, with stable but modest financial returns.
• The drug faces competitive pressure from newer, often safer diuretics like chlorthalidone and indapamide.
• Growth avenues include expanding access in developing countries and developing fixed-dose combinations.
• Long-term prospects depend heavily on regional prescribing trends, regulatory frameworks, and healthcare infrastructure development.

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FAQs

1. How has the patent expiration of chlorothiazide impacted its market?
Patent expiration in the 1980s led to widespread generic manufacturing, drastically lowering prices and increasing accessibility. However, it also resulted in diminished profit margins, positioning chlorothiazide as a low-cost medication with steady but limited revenue potential.

2. Are there any recent formulations or derivatives of chlorothiazide in development?
Research into long-acting formulations or fixed-dose combinations involving chlorothiazide exists but remains limited compared to newer diuretics. Most innovation centers on integrating chlorothiazide into combination therapies rather than reformulating the molecule itself.

3. What regions demonstrate the highest growth potential for chlorothiazide?
Emerging markets such as India and China offer significant growth opportunities due to expanding healthcare infrastructure, increasing hypertension prevalence, and demand for affordable medications.

4. How do clinical guidelines influence chlorothiazide's market dynamics?
Guidelines endorse thiazide diuretics as first-line therapy, supporting demand. However, recent shifts favor alternative agents with better safety profiles, potentially restricting chlorothiazide's broader use in developed countries.

5. What are the primary challenges facing chlorothiazide's continued market relevance?
Clinical preference for newer diuretics, regulatory concerns over metabolic side effects, and the development of fixed-dose combination drugs favoring other agents pose challenges to chlorothiazide's market longevity.

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References

1. [1] IQVIA. Global Market Data for Diuretics, 2022.
2. [2] Williams B, et al. "2018 ESC/ESH Guidelines for the Management of Arterial Hypertension." European Heart Journal, 2018.
3. [3] Tuomilehto J, et al. "Long-term effects of chlorthalidone vs. hydrochlorothiazide." BMJ, 2019.