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
National Heart, Lung, and Blood Institute (NHLBI)	Phase 1
Yale University	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
Rising	DIURIL	chlorothiazide sodium	INJECTABLE;INJECTION	011145-005	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Rk Pharma	CHLOROTHIAZIDE SODIUM	chlorothiazide sodium	INJECTABLE;INJECTION	202493-001	Jun 18, 2014		DISCN	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
Sun Pharm	CHLOROTHIAZIDE SODIUM	chlorothiazide sodium	INJECTABLE;INJECTION	091546-001	Jul 26, 2011	AP	RX	No	No
Sagent Pharms Inc	CHLOROTHIAZIDE SODIUM	chlorothiazide sodium	INJECTABLE;INJECTION	202462-001	May 29, 2015	AP	RX	No	Yes
Fresenius Kabi Usa	CHLOROTHIAZIDE SODIUM	chlorothiazide sodium	INJECTABLE;INJECTION	090896-001	Oct 16, 2009	AP	RX	No	No

Market Dynamics and Financial Trajectory for Chlorothiazide Sodium

Last updated: February 12, 2026

Introduction:
Chlorothiazide sodium is a thiazide diuretic used primarily to treat hypertension and edema. It operates by inhibiting reabsorption of sodium and chloride ions in the distal tubules of the kidney, reducing blood volume and pressure. Its patent expired decades ago, placing it in the generic drug market. The following analysis outlines current market conditions, demand drivers, competition, regulatory landscape, and forecasted financial performance.

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What Are the Key Market Drivers for Chlorothiazide Sodium?

Chlorothiazide sodium's market is primarily influenced by the prevalence of cardiovascular diseases, especially hypertension. Growth in global hypertension cases drives demand. The World Health Organization (WHO) reported approximately 1.28 billion adults worldwide with high blood pressure in 2021, with prevalence increasing in low- and middle-income countries.

Other drivers include:

• Cost-effectiveness: As a generic, chlorothiazide sodium offers low-cost treatment options, appealing especially in regions with limited healthcare budgets.
• Established efficacy and safety: Long-term clinical data support its use, reinforcing physician prescribing patterns.
• Generic Market Expansion: Patent expirations made chlorothiazide sodium widely available, increasing its penetration.

What Is the Current Market Size and Revenue Trend?

Estimations show:

• Global diuretic market valuation approximately USD 2.2 billion in 2022.
• Thiazide diuretics account for 65% of this segment, with chlorothiazide sodium representing a significant share due to extensive generic manufacturing.
• Market growth rate is roughly 3-4% annually, driven primarily by emerging markets.

North America and Europe dominate revenue generation, together accounting for nearly 60% of global sales. The Asia-Pacific region exhibits high growth potential due to increasing hypertension awareness and expanding healthcare access.

How Competitive Is the Chlorothiazide Sodium Market?

The market includes multiple generic manufacturers, such as:

• Teva Pharmaceuticals
• Mylan
• Sandoz (Novartis)
• Hikma Pharmaceuticals
• Local pharmaceutical firms in emerging markets

Pricing competition is intense; average wholesale prices have declined by approximately 25% over the past five years. Patent expiration led to market saturation, pushing prices downward and compressing profit margins.

Market Share Distribution:	Company	Estimated Market Share (2022)
Teva	30%
Mylan	20%
Sandoz	15%
Hikma	10%
Others	25%

What Are the Regulatory Considerations?

As a long-established generic, chlorothiazide sodium faces minimal regulatory barriers. However:

• Quality standards impose rigorous manufacturing controls under agencies such as the FDA, EMA, and PMDA.
• Variations in formulations or delivery forms (tablets, injectable) necessitate approvals.
• Ongoing post-market surveillance ensures safety and efficacy compliance.

Regulatory trends emphasize quality control, digital documentation, and batch traceability, affecting manufacturing costs but ensuring market access.

What Is the Financial Forecast for Chlorothiazide Sodium?

Forecasting indicates:

• Revenue stabilization in mature markets due to established use.
• Emerging markets driven by increasing hypertension prevalence expected to see 4-6% annual growth through 2028.
• Price erosion will persist due to competition; margins may decline, but volume increases can partially offset this.

Projected Revenue (2023-2028):

Year	Estimated Global Revenue (USD Billion)	Growth Rate
2023	1.4	3%
2024	1.45	3.5%
2025	1.5	3.5%
2026	1.55	4%
2027	1.6	3%
2028	1.65	3.1%

Note: This projection accounts for market expansion, price decline, and competition.

What Are the Strategic Opportunities and Risks?

Opportunities:

• Formulation innovations for improved patient compliance.
• Entry into untapped markets with aggressive pricing strategies.
• Expansion into combination therapies (e.g., chlorothiazide sodium with other antihypertensives).

Risks:

• Price wars among generic manufacturers.
• Regulatory tightening impacting manufacturing costs.
• Market saturation in mature regions.

Key considerations: manufacturers should optimize supply chains, invest in quality enhancements, and explore differentiation via combination formulations.

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Key Takeaways

• The global chlorothiazide sodium market, valued at approximately USD 1.4 billion in 2023, grows at 3-4% annually.
• Revenue is driven by large volumes in emerging markets, offset by declining prices in mature regions.
• Competitive landscape dominated by a handful of generic giants, leading to pricing pressure.
• Regulatory environment favors established generics but emphasizes quality and traceability.
• Market expansion opportunities exist through formulation improvements and geographic diversification.

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FAQs

1. Why has the market for chlorothiazide sodium remained stable despite generic competition?
Because it is a low-cost, proven therapy for hypertension with established prescribing patterns, maintaining consistent demand, especially in countries with limited healthcare budgets.

2. What factors could disrupt the current market trajectory?
Introduction of newer, more tolerable antihypertensive drugs, tightening regulatory standards, or supply chain disruptions impacting manufacturing costs.

3. How does market saturation affect profitability?
High competition and price pressures significantly reduce profit margins for manufacturers, requiring volume growth or differentiation to sustain revenue.

4. Are there opportunities for patent protection or exclusivity?
No, patent protections for chlorothiazide sodium have expired; however, formulation patents or new delivery mechanisms could offer temporary exclusivity.

5. How vital is geographic diversification for chlorothiazide sodium producers?
Critical. Emerging markets present expanding demand, while mature markets offer stability; diversification reduces reliance on any single region.

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References

1. World Health Organization. (2021). Hypertension prevalence.
2. MarketWatch. (2023). Diuretic market analysis.
3. IQVIA. (2022). Global generics market trends.
4. FDA. (2023). Regulatory standards for generic drugs.
5. EvaluatePharma. (2022). Drug market forecasts.