CHLOROTHIAZIDE - Generic Drug Details

What are the generic sources for chlorothiazide and what is the scope of patent protection?

Chlorothiazide is the generic ingredient in eleven branded drugs marketed by Salix Pharms, Abc Holding, Hikma Intl Pharms, Lederle, Norvium Bioscience, Sandoz, Watson Labs, Rising, Am Regent, Fresenius Kabi Usa, Gland Pharma Ltd, Rk Pharma, Sagent Pharms Inc, Sun Pharm, Merck, Par Pharm, and Hikma, and is included in thirty NDAs. Additional information is available in the individual branded drug profile pages.

There are forty-two drug master file entries for chlorothiazide. One supplier is listed for this compound.

Summary for CHLOROTHIAZIDE

US Patents:	0
Tradenames:	11
Applicants:	17
NDAs:	30
Drug Master File Entries:	42
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	98
Clinical Trials:	8
Patent Applications:	6,527
Drug Prices:	Drug price trends for CHLOROTHIAZIDE
What excipients (inactive ingredients) are in CHLOROTHIAZIDE?	CHLOROTHIAZIDE excipients list
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
Yale University	Phase 1

See all CHLOROTHIAZIDE clinical trials

Pharmacology for CHLOROTHIAZIDE

Drug Class	Thiazide Diuretic
Physiological Effect	Increased Diuresis

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
Rising	DIURIL	chlorothiazide	TABLET;ORAL	011145-004	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Watson Labs	CHLOROTHIAZIDE	chlorothiazide	TABLET;ORAL	086796-001	Aug 15, 1983		DISCN	No	No
Hikma Intl Pharms	CHLOROTHIAZIDE	chlorothiazide	TABLET;ORAL	087736-001	Jul 14, 1982		DISCN	No	No
Sagent Pharms Inc	CHLOROTHIAZIDE SODIUM	chlorothiazide sodium	INJECTABLE;INJECTION	202462-001	May 29, 2015	AP	RX	No	Yes
Watson Labs	CHLOROTHIAZIDE	chlorothiazide	TABLET;ORAL	084026-001	Sep 1, 1982		DISCN	No	No

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