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Last Updated: December 22, 2024

CHLOROTHIAZIDE Drug Patent Profile


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

Chlorothiazide is a drug marketed by Abc Holding, Hikma Intl Pharms, Lederle, Norvium Bioscience, Sandoz, Watson Labs, Hikma, Am Regent, Fresenius Kabi Usa, Gland Pharma Ltd, 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 16th, 2009.

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Drug patent expirations by year for CHLOROTHIAZIDE
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Recent Clinical Trials for CHLOROTHIAZIDE

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

SponsorPhase
University of VirginiaPhase 4
Vanderbilt UniversityPhase 4
National Heart, Lung, and Blood Institute (NHLBI)Phase 1

See all CHLOROTHIAZIDE clinical trials

Medical Subject Heading (MeSH) Categories for CHLOROTHIAZIDE
Anatomical Therapeutic Chemical (ATC) Classes for CHLOROTHIAZIDE

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 ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Gland Pharma Ltd CHLOROTHIAZIDE SODIUM chlorothiazide sodium INJECTABLE;INJECTION 218630-001 Oct 3, 2024 AP RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Norvium Bioscience CHLOROTHIAZIDE-RESERPINE chlorothiazide; reserpine TABLET;ORAL 087744-001 May 6, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Norvium Bioscience CHLOROTHIAZIDE chlorothiazide TABLET;ORAL 084217-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Lederle CHLOROTHIAZIDE chlorothiazide TABLET;ORAL 086940-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Watson Labs CHLOROTHIAZIDE chlorothiazide TABLET;ORAL 084026-001 Sep 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

CHLOROTHIAZIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Hydrochlorothiazide

Introduction

Hydrochlorothiazide, a thiazide diuretic, is widely used in the treatment of hypertension, fluid retention, and various other cardiovascular and renal conditions. The market for hydrochlorothiazide is influenced by several key factors, including demographic changes, healthcare expenditure, and regulatory environments.

Market Drivers

Increasing Prevalence of Hypertension

The global prevalence of hypertension is a significant driver for the hydrochlorothiazide market. According to the World Health Organization (WHO), approximately 1.13 billion people worldwide suffer from hypertension, and this number is expected to rise to 29% by 2025, particularly in economically developing nations[4].

Growing Geriatric Population

The increase in the geriatric population is another crucial factor. Older adults are more likely to develop hypertension and other conditions that require diuretic treatment, thereby boosting the demand for hydrochlorothiazide[1].

Rise in Healthcare Expenditure

Increased healthcare expenditure globally is driving the market growth. As more resources are allocated to healthcare, the demand for effective treatments like hydrochlorothiazide increases[1].

Research and Development Activities

Pharmaceutical companies are continuously involved in research and development activities, leading to the launch of novel and improved versions of hydrochlorothiazide. This innovation fuels market growth by offering better treatment options[1].

Market Trends

New Product Launches

The hydrochlorothiazide market is expected to flourish with new product launches. Pharmaceutical companies are developing various formulations such as tablets, capsules, and liquids to cater to different patient needs[4].

Competitive Landscape

The market is highly competitive with several key players such as Novartis, Mylan, Teva, Huaren Pharmaceutical, and others. This competition drives innovation and reduces prices, making the drug more accessible to a wider population[4].

Applications and End Users

Hypertension and Fluid Retention

Hydrochlorothiazide is primarily used to treat hypertension and fluid retention (edema) caused by conditions such as congestive heart failure, severe liver disease, and kidney disease[5].

Heart Attack and Kidney Failure

The drug is also used in the management of heart attacks and kidney failure, further expanding its market scope[4].

End Users

The primary end users include hospitals, drug stores, and other healthcare facilities. The ease of availability in these settings contributes to the market growth[4].

Regional Scenario

Global Market Analysis

The hydrochlorothiazide market is analyzed globally, with a focus on regions that have high prevalence rates of hypertension and other related conditions. Regions such as North America, Europe, and Asia-Pacific are significant markets due to their large patient populations and advanced healthcare systems[4].

Financial Trajectory

Market Size and Growth

The global hydrochlorothiazide market is expected to see incredible growth from 2021 to 2030. The market size and estimations are based on a comprehensive analysis of key developments in the industry. The forecast indicates a significant increase in market value driven by the increasing prevalence of hypertension and other cardiovascular diseases[4].

Revenue and Profit Margins

The revenue from hydrochlorothiazide sales is expected to rise as more patients are diagnosed and treated for hypertension and related conditions. However, profit margins may be affected by the entry of generic competitors, which can reduce prices and margins over time[3].

Challenges and Restraints

Side Effects

One of the major restraints for the hydrochlorothiazide market is the side effects associated with the drug. These can include electrolyte imbalances, increased urination, and other adverse effects, which may deter some patients and healthcare providers from using the drug[1].

Regulatory Scrutiny

The FDA's increased scrutiny of generic drug applications can also impact the market. Higher costs associated with obtaining FDA approval can delay market entry for new generic versions, potentially affecting the overall market dynamics[3].

Competitive Analysis

Key Market Players

The market is dominated by several key players, including Novartis, Mylan, Teva, Huaren Pharmaceutical, and others. These companies are involved in continuous R&D and strategic business planning to maintain their market share[4].

Porter’s Five Forces Analysis

The competitive intensity in the hydrochlorothiazide market can be analyzed using Porter’s Five Forces model. This includes the bargaining power of buyers and suppliers, the threat of new entrants, the threat of substitute products, and the competitive rivalry among existing competitors[1].

Future Outlook

Increasing Demand

The demand for hydrochlorothiazide is expected to increase due to the growing prevalence of hypertension and other cardiovascular diseases. This trend is likely to continue, driven by demographic changes and advancements in healthcare[4].

Technological Advancements

Technological advancements in drug formulation and delivery systems are expected to enhance the market. New formulations and delivery methods can improve patient compliance and treatment outcomes, further boosting the market growth[1].

Key Takeaways

  • The hydrochlorothiazide market is driven by the increasing prevalence of hypertension, growing geriatric population, and rising healthcare expenditure.
  • New product launches and competitive landscape are key trends shaping the market.
  • The drug is used primarily for hypertension, fluid retention, heart attack, and kidney failure.
  • The market faces challenges such as side effects and regulatory scrutiny.
  • Key players are investing heavily in R&D to maintain market share.

FAQs

What are the primary applications of hydrochlorothiazide?

Hydrochlorothiazide is primarily used to treat hypertension, fluid retention (edema), heart attack, and kidney failure.

Which regions are significant for the hydrochlorothiazide market?

Regions such as North America, Europe, and Asia-Pacific are significant due to their large patient populations and advanced healthcare systems.

What are the major challenges facing the hydrochlorothiazide market?

The major challenges include side effects associated with the drug and regulatory scrutiny that can increase the cost of obtaining FDA approval.

Who are the key players in the hydrochlorothiazide market?

Key players include Novartis, Mylan, Teva, Huaren Pharmaceutical, and others.

How is the competitive landscape of the hydrochlorothiazide market?

The market is highly competitive with several key players involved in continuous R&D and strategic business planning to maintain their market share.

Sources

  1. Allied Market Research: Hydrochlorothiazide Market Size | Industry Growth, (2021-2030)
  2. JAMA Network: CLINICAL STUDIES ON HYDROCHLOROTHIAZIDE
  3. Federal Trade Commission: Generic Drug Industry Dynamics
  4. EIN Presswire: Hydrochlorothiazide Market To See Incredible Growth During 2021–2030
  5. Mayo Clinic: Chlorothiazide (oral route) - Mayo Clinic

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