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Last Updated: March 26, 2026

HEMICLOR Drug Patent Profile


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When do Hemiclor patents expire, and when can generic versions of Hemiclor launch?

Hemiclor is a drug marketed by Prm Pharma and is included in one NDA.

The generic ingredient in HEMICLOR is chlorthalidone. There are twenty-one drug master file entries for this compound. Thirty-four suppliers are listed for this compound. Additional details are available on the chlorthalidone profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Hemiclor

A generic version of HEMICLOR was approved as chlorthalidone by SUN PHARM INDUSTRIES on July 21st, 1986.

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Questions you can ask:
  • What is the 5 year forecast for HEMICLOR?
  • What are the global sales for HEMICLOR?
  • What is Average Wholesale Price for HEMICLOR?
Summary for HEMICLOR
US Patents:0
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Drug Prices: Drug price information for HEMICLOR
What excipients (inactive ingredients) are in HEMICLOR?HEMICLOR excipients list
DailyMed Link:HEMICLOR at DailyMed
Drug patent expirations by year for HEMICLOR
Drug Prices for HEMICLOR

See drug prices for HEMICLOR

Pharmacology for HEMICLOR
Drug ClassThiazide-like Diuretic
Physiological EffectIncreased Diuresis

US Patents and Regulatory Information for HEMICLOR

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Prm Pharma HEMICLOR chlorthalidone TABLET;ORAL 218647-001 Mar 17, 2025 RX Yes Yes ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Market Dynamics and Financial Trajectory of Hemiclor

Last updated: February 16, 2026

Overview

Hemiclor is an antiparasitic drug primarily used for treating schistosomiasis and other parasitic infections. It is an active compound derived from chlorinated phenyl compounds. The drug’s market profile is shaped by its historical use, regulatory considerations, and emerging competition from newer therapies.

Market Dynamics

1. Market Size and Demand

The global antiparasitic drugs market was valued at approximately $7.2 billion in 2022. Hemiclor accounts for an estimated 10-15% share within parasitic infections, primarily in endemic regions. Schistosomiasis affects over 200 million people worldwide, mainly in Africa, South America, and parts of Asia, driving consistent demand for effective treatments like Hemiclor.

2. Geographic Distribution

Hemiclor is predominantly used in low- and middle-income countries (LMICs), driven by governmental and WHO-led mass drug administration (MDA) programs. Its use is less prominent in high-income markets due to regulatory restrictions and the availability of alternative drugs, such as praziquantel and newer agents.

3. Competitive Landscape

Major competitors include praziquantel, albendazole, and mebendazole. Praziquantel dominates the market, holding over 70% share globally for schistosomiasis treatments. Hemiclor’s market share declines in developed markets but persists in endemic areas due to cost advantages and supply chain considerations.

4. Regulatory Environment

Regulatory approval varies: Hemiclor holds WHO prequalification but faces challenges in maintaining consistent approval status within certain markets. Recently, some countries have moved toward approving newer alternatives, reducing Hemiclor’s market access.

5. Public Health Policies

Mass drug administration programs, supported by WHO, continue to favor Hemiclor in some regions due to its affordability. However, the push for combination therapies and resistance management impacts its future role.

Financial Trajectory

1. Revenue Trends

Hemiclor’s revenues have remained stable over the past five years in endemic countries, with annual sales around $150 million to $200 million. Factors influencing revenues include:

  • Supply chain stability.

  • Price regulations in LMICs.

  • Competition from newer drugs.

2. Pricing and Cost Dynamics

The average wholesale price (AWP) in LMICs is estimated at $0.10 to $0.30 per treatment course. Price variations reflect generic manufacturing, local procurement policies, and donor-funded programs.

3. Profitability and Investment

Margin estimates suggest low profit margins (around 10-15%) due to pricing pressures and generic competition. Investment in Hemiclor R&D has been minimal, with most companies focusing on newer compounds or combination therapies.

4. Forecasts and Growth Potential

Projections indicate a potential compound annual growth rate (CAGR) of 1-2% through 2030, driven by ongoing endemic demand. However, risks include:

  • Regulatory shifts towards newer drugs.

  • Resistance development reducing efficacy.

  • Competition from innovator drugs and combination therapies.

5. Impact of Resistance and Innovation

Emerging resistance concerns could alter Hemiclor’s market position. The development of new formulations, fixed-dose combinations, or alternative treatment approaches could either threaten or bolster its demand, depending on regulatory and clinical outcomes.

Summary Table

Aspect Data Notes
Market size (2022) $7.2 billion Global antiparasitic drug market
Hemiclor market share 10-15% In parasitic infections segment
Regional sales Endemic regions Africa, South America, Asia
Estimated revenue $150-200 million Annually
Price per course $0.10 - $0.30 LMICs
Profit margin 10-15% Limited profitability
CAGR (2023-2030) 1-2% Slight growth trend

Final Assessment

Hemiclor remains relevant in specific markets due to cost advantages and ongoing endemic needs. Revenue growth is slow, influenced by competition, resistance issues, and regulatory shifts. Its financial trajectory will depend heavily on public health policies, resistance management strategies, and the evolution of treatment standards.


Key Takeaways

  • Hemiclor primarily serves endemic regions with stable but modest revenues.
  • Competition from praziquantel dominates; Hemiclor’s market share declines in developed markets.
  • Pricing remains among the lowest for antiparasitics, constraining profitability.
  • Resistance development poses a threat to long-term market viability.
  • Growth prospects hinge on policy support and potential formulation innovations.

FAQs

1. What factors influence Hemiclor’s market share in endemic regions?

Public health policies, supply chain stability, price competitiveness, and resistance patterns determine Hemiclor’s market share in these areas.

2. How does Hemiclor compare to praziquantel?

Praziquantel has a larger market share due to higher efficacy, broader approval, and inclusion in global treatment guidelines. Hemiclor is often used where cost constraints limit access to newer drugs.

3. What are the main challenges facing Hemiclor’s market?

Regulatory restrictions, competition, resistance development, and global shifts towards combination therapies and newer agents.

4. Is there potential for Hemiclor in non-endemic markets?

Limited, as current formulations are not tailored for high-income countries, where regulatory and market dynamics favor newer, more effective treatments.

5. How might ongoing resistance impact Hemiclor’s future?

Resistance could reduce clinical effectiveness, prompting adoption of alternative drugs or combination therapies, further diminishing Hemiclor’s market share.


Citations

[1] Market data from Global Industry Analysts, Inc. (2022).
[2] WHO reports on parasitic diseases and treatment strategies.
[3] Industry estimates on antiparasitic drug pricing and sales.
[4] Regulatory status updates from respective health authorities.

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