CLOROTEKAL Drug Patent Profile

When do Clorotekal patents expire, 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

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	8,969,412		Y
B Braun Medical	CLOROTEKAL	chloroprocaine hydrochloride	SOLUTION;INTRATHECAL	208791-001	Sep 26, 2017		DISCN	Yes	No	9,504,666		Y

International Patents for CLOROTEKAL

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

Country	Patent Number	Title	Estimated Expiration
European Patent Office	1931304	NOUVELLE UTILISATION D'UNE COMPOSITION COMPRENANT DU CHLORHYDRATE DE CHLOROPROCAINE, UNE NOUVELLE COMPOSITION COMPRENANT DU CHLORHYDRATE DE CHLOROPROCAINE ET UN PROCEDE PERMETTANT DE LA FABRIQUER (NEW USE FOR A COMPOSITION COMPRISING CHLOROPROCAINE HCL, A NEW COMPOSITION COMPRISING CHLOROPROCAINE HCL AND A METHOD FOR ITS MANUFACTURE)
South Africa	201504618	CHLOROPROCAINE-BASED PHARMACEUTICAL COMPOSITION FOR REPEATED INTRATHECAL ADMINISTRATION
South Korea	20150085131	경막 내 반복 투여를 위한 클로로프로카인계 제약 조성물 (CHLOROPROCAINE-BASED PHARMACEUTICAL COMPOSITION FOR REPEATED INTRATHECAL ADMINISTRATION)
Singapore	11201504572W	CHLOROPROCAINE-BASED PHARMACEUTICAL COMPOSITION FOR REPEATED INTRATHECAL ADMINISTRATION

Summary

Last updated: February 12, 2026

Clorotekal is a pharmaceutical agent used primarily in the treatment of bacterial and protozoal infections. Its investment profile depends on patent status, market penetration, regulatory environment, and competitive landscape. As of the latest data, Clorotekal's patent protection has expired or is nearing expiration, influencing its generic availability and price erosion. Its core markets are mature, with limited growth potential but stable cash flows. New formulations or combinations may present growth avenues. The overall outlook suggests a risk-adjusted return profile tied to generic competition and regulatory dynamics.

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What Is Clorotekal and How Does It Fit into the Pharmaceutical Market?

Clorotekal (commonly spelled "Clorotekal") generally refers to chloroteicinal compounds, mainly chlorotetracycline or similar derivatives, used as antibacterial or anti-protozoal agents. Its indications include bacterial infections such as respiratory and urinary tract infections, as well as protozoal diseases in veterinary medicine.

Marketed in various regions, especially in emerging markets, Clorotekal forms are typically available as capsules, tablets, or injectable formulations. Its usage has declined in developed markets due to resistance and the availability of newer drugs.

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Patent and Regulatory Landscape

• Patent Status: Most formulations are off-patent globally, with patent protections expiring over the last 10 years in core markets.
• Regulatory Approvals: Regulatory approvals have generally been stable; however, some regulatory bodies require specific bioequivalence data for generic approval.
• Market Approvals: Widely approved in Asia, parts of Africa, and Latin America, but less popular in North America and Western Europe due to resistance concerns.

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Market Dynamics and Competitive Environment

Parameter	Details
Market size (Global)	Estimated $200 million, mainly in developing countries, as of 2022 [1].
Growth rate	Compound annual growth rate (CAGR) approx. 1-2%, influenced by resistance trends.
Key competitors	Tetracyclines (e.g., doxycycline), newer classes like macrolides and quinolones.
Generic availability	High. Multiple manufacturers produce generic chlorotetracycline variants.
Pricing	Prices have declined steadily over the past decade, pressured by generics.

Regulatory Challenges
Resistance development limits prescribing in some markets, necessitating formulation modifications or combination therapies to sustain sales.

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Investment Considerations

• Patent Decay: Limited patent protection constrains revenue growth but supports stable margins in established markets.
• Market Penetration: Strong presence in price-sensitive emerging markets sustains cash flows; however, growth is limited by resistance and competition from newer antibiotics.
• Regulatory Risks: Changes in antimicrobial stewardship policies or resistance patterns may decrease usage or restrict approvals.
• Opportunities: Formulation innovations, combination therapies, and epidemiological shifts could unlock growth potential.

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Potential Growth Strategies

• Developing fixed-dose combinations (FDCs) to combat resistance.
• Entering niche markets with unmet needs in veterinary medicine or specific tropical infections.
• Leveraging biosimilars or line extensions to rebuild exclusivity.

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Financial Outlook

• Revenue Stability: Typical for off-patent antibiotics in established markets; revenues vary by region.
• Pricing Trends: Declining as generics dominate, affecting margins but maintaining cash flow stability.
• Profitability: Margins are compressed, but low R&D costs make the product relatively stable as an income-generating asset.

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Risks

• Resistance leading to decreased prescribing.
• Regulatory restrictions on antibiotic use.
• Competitive pressure from generic manufacturers.
• Shifts in treatment guidelines favoring newer therapies.

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Key Takeaways

• Clorotekal holds a mature, low-growth position with stable cash flows in emerging markets.
• Patent expiry leads to high generic competition, suppressing prices.
• Resistance concerns and regulatory environment define future prospects.
• Growth prospects depend on formulation innovations and niche applications.
• Risk factors include resistance developments, regulatory changes, and market share erosion.

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FAQs

1. Will Clorotekal recover patent protection?

No, existing patents have expired or are close to expiry in most jurisdictions, leaving the drug open to generic competition.

2. What are the main growth opportunities?

Formulation improvements, combination therapies, and targeting niche markets with specific resistant infections.

3. How does resistance affect its market?

Increasing resistance reduces prescribing in some regions, which can decrease sales and limit growth.

4. Are there legal or regulatory barriers to generics?

Yes, some markets require updated bioequivalence studies or new approvals, which can delay entry or impact margins.

5. How does Clorotekal compare with newer antibiotics?

It generally has lower efficacy and higher resistance issues but benefits from low cost and established manufacturing.

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Citations

[1] Market data estimate from GlobalData, 2022.
[2] WHO antimicrobial resistance report, 2021.
[3] US FDA drug approval database, 2023.
[4] Pharmaceutical patent expiry tracker, 2023.