CHLOROTHIAZIDE Drug Patent Profile

When do Chlorothiazide patents expire, and what generic alternatives are available?

Chlorothiazide is a drug marketed by Abc Holding, Hikma Intl Pharms, Lederle, Pharmobedient, Sandoz, Watson Labs, Hikma, Am Regent, Fresenius Kabi Usa, Gland, Rk Pharma, Sagent Pharms Inc, and Sun Pharm. and is included in twenty-four NDAs.

The generic ingredient in CHLOROTHIAZIDE is chlorothiazide sodium. There are forty-two drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the chlorothiazide sodium profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Chlorothiazide

A generic version of CHLOROTHIAZIDE was approved as chlorothiazide sodium by FRESENIUS KABI USA on October 16^th, 2009.

Summary for CHLOROTHIAZIDE

US Patents:	0
Applicants:	13
NDAs:	24
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	8
Patent Applications:	4,292
Drug Prices:	Drug price information for CHLOROTHIAZIDE
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

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
Abc Holding	CHLOROTHIAZIDE	chlorothiazide	TABLET;ORAL	085569-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Gland	CHLOROTHIAZIDE SODIUM	chlorothiazide sodium	INJECTABLE;INJECTION	218630-001	Oct 3, 2024	AP	RX	No	No
Pharmobedient	CHLOROTHIAZIDE-RESERPINE	chlorothiazide; reserpine	TABLET;ORAL	087744-001	May 6, 1982		DISCN	No	No
Pharmobedient	CHLOROTHIAZIDE	chlorothiazide	TABLET;ORAL	084217-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Lederle	CHLOROTHIAZIDE	chlorothiazide	TABLET;ORAL	086940-001	Approved Prior to Jan 1, 1982		DISCN	No	No

Last updated: February 13, 2026

What Are the Market Dynamics for Chlorothiazide?

Chlorothiazide is a thiazide diuretic approved for hypertension and edema management. Its market landscape has experienced shifts driven by generic competition, patent status, therapeutic guidelines, and alternative drugs.

Market Size and Growth Trends

• The global diuretics market, including chlorothiazide, was valued at approximately $4.2 billion in 2022 (Source: Market Research Future [1]).
• The segment covering thiazide diuretics is a significant portion, with an estimated compound annual growth rate (CAGR) of 1.8% from 2023 to 2030.
• Chlorothiazide's contribution has declined over the past decade because of competition from newer diuretics with improved tolerability and efficacy.

Key Market Drivers and Challenges

Drivers:

• Established efficacy and generic availability.
• Prescriptions for hypertension and edema, especially in developing countries.
• Favorable safety profile for many patients.

Challenges:

• Emergence of alternatives, including ACE inhibitors, ARBs, and calcium channel blockers.
• Safety concerns, such as hyponatremia and hypokalemia, especially in elderly patients.
• Decline in patent protection; most formulations are now off-patent.

Market Share Dynamics

Segment	Market Share (2022)	Notes
Generic chlorothiazide	>95%	Due to patent expiration; sold as generics.
Brand-name drugs	<5%	Limited; mainly used in fixed-dose combinations or specific formulations.

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How Does the Financial Trajectory of Chlorothiazide Look?

Revenue Analysis

• Revenues for chlorothiazide have declined sharply in recent years.
• In the U.S., annual sales are estimated below $20 million, primarily from generic sales.
• Global sales are difficult to isolate but are expected to be under $50 million annually, representing a small fraction of the diuretics market.

Pricing Trends

Year	Average Price per Unit	Comment
2015	~$0.50	Relatively stable.
2020	~$0.45	Slight decline due to generics.
2022	~$0.40	Continued price erosion.

Pricing declines stem from increased generic competition, as few patents have remained active since the late 2000s.

Investment and R&D Considerations

• No recent notable R&D investment as priority shifts to newer therapeutics.
• Market decline discourages major investment, although niche formulations or combination therapies might sustain some interest.

Regulatory Status and Patents

• Initial patent protection expired in the early 2000s.
• Current formulations are off-patent; thus, marketing depends solely on generics registration.

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How Will Future Market and Financial Trends Evolve?

Market Evolution

• The role of chlorothiazide in hypertension management has diminished as guidelines favor ACE inhibitors, ARBs, and calcium channel blockers.
• Use in combination therapies may sustain some demand but generally limited.
• Emerging markets might maintain some consumption due to pricing and formulary preferences.

Financial Outlook

• Revenue likely to decline further given the drug’s off-patent status and competition.
• No major investment or innovation expected.
• Stable niche presence possibly in some low-resource settings.

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What Are the Implications for Stakeholders?

Pharmaceutical companies:
Focus on formulations with patent protection or on combination products containing chlorothiazide.

Investors:
Chlorothiazide offers limited growth prospects; focus on companies with diversified portfolios in antihypertensive drugs.

Healthcare providers:
Transition to newer, safer, or more effective therapies is ongoing, possibly reducing the clinical use of chlorothiazide.

Regulators:
Monitor for off-label uses and generic market practices that could impact drug safety and pricing.

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Key Takeaways

• Chlorothiazide operates mainly in a mature, declining market dominated by generics.
• Global sales are minimal, with revenue declining annually.
• Market drivers have shifted toward newer antihypertensives; chlorothiazide's role remains marginal.
• Future growth prospects are minimal; investment focus should favor innovation in hypertension therapeutics.
• Stakeholders should evaluate formulations, patent status, and competitive landscape when considering chlorothiazide.

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FAQs

1. Is chlorothiazide still prescribed for hypertension?
Yes, but its use has decreased as clinicians prefer newer medications with better safety profiles.

2. What is the current patent status of chlorothiazide?
All patents have expired; it is available as a generic.

3. Are there any new formulations of chlorothiazide in development?
No significant R&D initiatives are publicly known.

4. How does chlorothiazide compare with newer diuretics?
It has similar efficacy but a higher risk of electrolyte disturbances and less tolerability.

5. What regulatory hurdles exist for chlorothiazide?
Since off-patent, regulatory hurdles are minimal; focus is on manufacturing standards and off-label use monitoring.

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References

1. Market Research Future. "Diuretics Market Research Report," 2022.