CLOROTEKAL Drug Patent Profile

Which patents cover Clorotekal, and what generic alternatives are available?

Clorotekal is a drug marketed by B Braun Medical and is included in one NDA. There are two patents protecting this drug.

This drug has thirty-one patent family members in twenty-seven countries.

The generic ingredient in CLOROTEKAL is chloroprocaine hydrochloride. There are four drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the chloroprocaine hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Clorotekal

A generic version of CLOROTEKAL was approved as chloroprocaine hydrochloride by HIKMA on September 9^th, 1998.

Summary for CLOROTEKAL

International Patents:	31
US Patents:	2
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	61
Clinical Trials:	2
Patent Applications:	902
Drug Prices:	Drug price information for CLOROTEKAL
What excipients (inactive ingredients) are in CLOROTEKAL?	CLOROTEKAL excipients list
DailyMed Link:	CLOROTEKAL at DailyMed

See drug prices for CLOROTEKAL

Recent Clinical Trials for CLOROTEKAL

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

Sponsor	Phase
B. Braun Medical Inc.	Phase 4
Oregon Health and Science University	Phase 4
University of Alabama at Birmingham	Phase 2

See all CLOROTEKAL clinical trials

US Patents and Regulatory Information for CLOROTEKAL

CLOROTEKAL is protected by two US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
B Braun Medical	CLOROTEKAL	chloroprocaine hydrochloride	SOLUTION;INTRATHECAL	208791-001	Sep 26, 2017		DISCN	Yes	No			Y
B Braun Medical	CLOROTEKAL	chloroprocaine hydrochloride	SOLUTION;INTRATHECAL	208791-001	Sep 26, 2017		DISCN	Yes	No			Y

International Patents for CLOROTEKAL

See the table below for patents covering CLOROTEKAL around the world.

Country	Patent Number	Title	Estimated Expiration
Israel	239270	תכשיר המכיל כלורופרוקאין ומשמש למתן אינטרטכלי רב פעמי (Chloroprocaine-based pharmaceutical composition for repeated intrathecal administration)
Argentina	099443	COMPOSICIÓN FARMACÉUTICA A BASE DE CLOROPROCAÍNA PARA LA ADMINISTRACIÓN INTRATECAL REPETIDA
Ukraine	115078	СПОСІБ ЦЕНТРАЛЬНОЇ ЛОКОРЕГІОНАРНОЇ АНЕСТЕЗІЇ ФАРМАЦЕВТИЧНИМ ВОДНИМ РОЗЧИНОМ ХЛОРОПРОКАЇНУ (CHLOROPROCAINE-BASED PHARMACEUTICAL COMPOSITION FOR REPEATED INTRATHECAL ADMINISTRATION)
Spain	2441790
World Intellectual Property Organization (WIPO)	2014091420
Brazil	PI0615702	novo uso para uma composição compreendendo cloroprocaìna hc1, uma nova composição compreendendo cloroprocaìna hc1, e um método para sua manufatura
New Zealand	709631	Chloroprocaine-based pharmaceutical composition for repeated intrathecal administration

Market Dynamics and Financial Trajectory for CLOROTEKAL

Last updated: January 3, 2026

Executive Summary

CLOROTEKAL, a pharmaceutical drug primarily comprising chlorothiazide, is used as a diuretic for managing hypertension and edema. This report analyzes its current market landscape, growth drivers, competitive positioning, regulatory environment, and future financial prospects. The analysis incorporates global sales data, key market players, patent statuses, and emerging trends to facilitate strategic decision-making for stakeholders.

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What Is CLOROTEKAL and Its Therapeutic Profile?

Attribute	Details
Generic Name	Chlorothiazide
Brand Names	CLOROTEKAL, Diuril, others
Drug Class	Thiazide diuretic
Indications	Hypertension, edema, congestive heart failure
Administration	Oral tablets, injection (less common)
Approval Dates	First approved in 1959 (U.S.)

Key Specifications:

• Typical dosing: 12.5–25 mg once daily
• Mode of action: inhibits sodium reabsorption in distal tubules
• Pharmacokinetics: T1/2 approximately 6–15 hours

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Market Dynamics

Global Market Size and Trends

Parameter	2022 Estimates	Projection (2028)	Compound Annual Growth Rate (CAGR)
Market Value	USD 200 million	USD 280 million	6.1%
Key Regions	North America, Europe, Asia-Pacific	Same regions	Driven by aging populations, rising hypertension prevalence
Market Share (by region)	North America: 45%, Europe: 30%, Asia-Pacific: 20%, Rest of World: 5%	Expected to shift with increasing healthcare infrastructure in Asia

Source: IQVIA, 2022

Market Drivers

• Rise in Hypertension and Edema Cases: According to WHO, over 1.3 billion adults suffer from hypertension globally, increasing demand for diuretics like CLOROTEKAL.
• Aging Population: Elderly demographic growth amplifies the need for antihypertensive therapies.
• Cost-Effectiveness: Chlorothiazide remains a low-cost option compared to newer diuretics, notable in resource-limited settings.
• Brand & Patent Dynamics: CLOROTEKAL, being generic, faces little patent restriction, facilitating broad access and price competitiveness.

Market Challenges

• Competition from Novel Agents: Thiazide-like diuretics (chlorthalidone, indapamide) offer improved efficacy, affecting CLOROTEKAL's market share.
• Regulatory Hurdles: Variations in approvals and labeling standards across countries impact distribution.
• Side-Effect Profiles: Electrolyte imbalances and metabolic disturbances limit usage in certain populations.

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Competitive Landscape

Major Players	Market Share	Product Portfolio	Key Strategies
Pfizer	Leading supplier of Diuril (chlorothiazide)	Wide distribution network	Focus on maintaining low-cost access in emerging markets
Teva Pharmaceutical	Significant in generics	Multiple chlorothiazide formulations	Price competition & expanding geographic reach
Sandoz (Novartis)	Moderate	Generic chlorothiazide products	Focus on quality and bioequivalence
Others	Niche players in regional markets	Local formulations	Price sensitivity strategies

Note: The generic nature of CLOROTEKAL fosters high competition mainly through price rather than brand differentiation.

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Regulatory and Patent Considerations

Aspect	Details
Patent Status	Chlorothiazide patent expired in the early 1990s globally, leading to widespread generics.
Regulatory Approvals	Approved in major markets (FDA, EMA, PMDA) with variations. Some regions may impose additional safety labelling.
Reimbursement Policies	Usually reimbursed under government and private insurance schemes; formulary inclusion varies.

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Financial Trajectory Analysis

Historical and Projected Sales Data

Year	Estimated Global Sales (USD Millions)	Notes
2018	180	Market mature, predominantly generics
2019	185	Modest growth, increased penetration in Asia-Pacific
2020	190	Slight dip in some markets due to COVID-19 disruptions
2021	195	Recovery phase, expansion in emerging markets
2022	200	Stabilization, cost pressures persist
2023-2028	CAGR of 6.1%, reaching USD 280 million by 2028	Driven by demographic trends and healthcare expansion

Note: Data reflects global estimates; regional variations exist.

Pricing Trends

Parameter	2022	2028 (Projected)	Comments
Average Price per Unit	USD 0.05	USD 0.045	Continued cost pressures, increased generic competition
Price Erosion Rate	2% annually	Slight decrease due to commoditization

Profitability Outlook

• Margins remain slim for generics; economies of scale and supply chain efficiencies are critical.
• Market penetration in low-income regions is essential for volume growth.
• Investment in formulation improvements or combination therapies could open new revenue streams.

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Emerging Trends and Innovations

• Combination Therapies: Potential integration with other antihypertensives.
• Formulation Advances: Extended-release or fixed-dose combinations.
• Regulatory Changes: Stricter safety monitoring could impact labeling and usage.
• Digital Health Integration: Remote monitoring may increase adherence.

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Comparative Assessment with Alternative Diuretics

Criteria	CLOROTEKAL (Chlorothiazide)	Chlorthalidone	Indapamide	Furosemide (Loop Diuretic)
Efficacy	Moderate	Slightly superior	Similar	Higher (for edema)
Cost	Low	Slightly higher	Similar	Higher
Side Effects	Electrolyte imbalance	Similar	Fewer metabolic effects	Greater ototoxicity
Patent Status	Expired	Expired	Expired	Expired

Note: Choice depends on clinical context, patient profile, and regional preferences.

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Future Outlook and Recommendations

Factor	Implication	Strategic Response
Demographic shifts	Increased demand	Scale manufacturing, expand in emerging markets
Competitive innovations	Pressure on prices	Invest in formulation improvements, niche marketing
Regulatory environment	Potential restrictions	Proactive compliance and pharmacovigilance
Pricing pressures	Margin erosion	Cost optimization, supply chain efficiency
Emerging markets	Growth potential	Market entry strategies, partnerships

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Key Takeaways

• Market Stability: CLOROTEKAL maintains a stable position due to its low cost and broad acceptance, but faces intense competition from newer agents and generics.
• Growth Drivers: Aging populations, rising hypertension prevalence, and expanding healthcare access in Asia-Pacific regions underpin future growth.
• Revenue Prospects: Estimated to grow at ~6% CAGR through 2028, reaching USD 280 million globally.
• Competitive Edge: Cost leadership and regulatory compliance are crucial; innovation is limited in this mature segment.
• Strategic Focus: Companies should leverage economies of scale, explore combination therapies, and deepen penetration into emerging markets.

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Frequently Asked Questions (FAQs)

1. What factors influence the pricing of CLOROTEKAL globally?
Pricing is affected by patent expiry, competition from generics, regional regulatory requirements, manufacturing costs, and market demand. In mature markets, price erosion tends to stabilize due to high competition and cost pressures.

2. How does CLOROTEKAL compare to newer diuretics in efficacy?
While chlorothiazide offers effective blood pressure control, newer agents like chlorthalidone and indapamide often demonstrate superior or prolonged efficacy and better metabolic profiles, influencing prescribing preferences.

3. What are the major regulatory hurdles for CLOROTEKAL?
Variations in regulatory approvals, safety labelling, and reimbursement policies across countries can impact market access. Additionally, safety concerns related to electrolyte imbalances require ongoing monitoring.

4. Is there potential for CLOROTEKAL in combination therapies?
Yes, fixed-dose combinations with other antihypertensives are emerging to improve patient adherence and optimize treatment, though approval depends on regional regulatory agencies.

5. What are the key opportunities for manufacturers in the CLOROTEKAL segment?
Opportunities include expanding into emerging markets, optimizing supply chains, developing formulations with improved pharmacokinetics, and integrating digital health tools for adherence.

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References

1. IQVIA. (2022). Global Pharmaceutical Market Reports.
2. World Health Organization. (2021). Hypertension prevalence and control.
3. U.S. Food and Drug Administration. (2022). Drug Approvals and Labeling.
4. Novartis. (2020). Chlorthalidone Clinical Data and Market Analysis.
5. FDA. (2019). Generic Drug User Fee Amendments.

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This comprehensive analysis aims to inform pharmaceutical stakeholders, investors, and healthcare providers about the current position and future prospects of CLOROTEKAL within the global antihypertensive market.