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Last Updated: December 22, 2024

CHLOROTHIAZIDE SODIUM Drug Patent Profile


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Which patents cover Chlorothiazide Sodium, and when can generic versions of Chlorothiazide Sodium launch?

Chlorothiazide Sodium is a drug marketed by Am Regent, Fresenius Kabi Usa, Gland Pharma Ltd, Rk Pharma, Sagent Pharms Inc, and Sun Pharm. and is included in six NDAs.

The generic ingredient in CHLOROTHIAZIDE SODIUM 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 Sodium

A generic version of CHLOROTHIAZIDE SODIUM was approved as chlorothiazide sodium by FRESENIUS KABI USA on October 16th, 2009.

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Summary for CHLOROTHIAZIDE SODIUM
US Patents:0
Applicants:6
NDAs:6
Finished Product Suppliers / Packagers: 5
Raw Ingredient (Bulk) Api Vendors: 9
Clinical Trials: 4
Patent Applications: 14
What excipients (inactive ingredients) are in CHLOROTHIAZIDE SODIUM?CHLOROTHIAZIDE SODIUM excipients list
DailyMed Link:CHLOROTHIAZIDE SODIUM at DailyMed
Drug patent expirations by year for CHLOROTHIAZIDE SODIUM
Recent Clinical Trials for CHLOROTHIAZIDE SODIUM

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

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

See all CHLOROTHIAZIDE SODIUM clinical trials

Pharmacology for CHLOROTHIAZIDE SODIUM
Drug ClassThiazide Diuretic
Physiological EffectIncreased Diuresis
Anatomical Therapeutic Chemical (ATC) Classes for CHLOROTHIAZIDE SODIUM

US Patents and Regulatory Information for CHLOROTHIAZIDE SODIUM

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Am Regent CHLOROTHIAZIDE SODIUM chlorothiazide sodium INJECTABLE;INJECTION 202561-001 Apr 22, 2013 AP RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Rk Pharma CHLOROTHIAZIDE SODIUM chlorothiazide sodium INJECTABLE;INJECTION 202493-001 Jun 18, 2014 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Fresenius Kabi Usa CHLOROTHIAZIDE SODIUM chlorothiazide sodium INJECTABLE;INJECTION 090896-001 Oct 16, 2009 AP RX 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 SODIUM Market Analysis and Financial Projection Experimental

Chlorothiazide Sodium Injection Market Dynamics and Financial Trajectory

Introduction

Chlorothiazide sodium injection is a diuretic used as adjunctive therapy in various medical conditions, including edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. The market for this drug has been witnessing significant growth, driven by several key factors.

Market Size and Forecast

The global chlorothiazide sodium injection market has shown substantial growth in recent years. As of 2023, the market size was valued at approximately USD 300 million and is projected to reach around USD 450 million by 2031. This growth is attributed to the increasing demand for effective diuretic treatments and the expanding patient population suffering from conditions that require such therapy[4].

Segmentation

The market is segmented based on application, product, and geography. Key applications include hospitals, clinics, and recovery centers, while the product segment is divided into 250mg/vial and 500mg/vial formulations. Geographically, the market is spread across North America, Europe, Asia-Pacific, South America, and the Middle East and Africa. Each segment contributes to the overall growth and dynamics of the market[1].

Drivers of Market Growth

Several factors drive the growth of the chlorothiazide sodium injection market:

Increasing Prevalence of Chronic Conditions

The rising incidence of chronic conditions such as congestive heart failure, hepatic cirrhosis, and renal dysfunction fuels the demand for diuretic treatments like chlorothiazide sodium injection[2].

Advancements in Healthcare Infrastructure

Improvements in healthcare infrastructure, particularly in developing regions, enhance the accessibility and affordability of these treatments, contributing to market expansion[1].

Growing Geriatric Population

The increasing geriatric population, which is more prone to the conditions treated by chlorothiazide sodium, also drives market growth[4].

Restraints and Challenges

Despite the positive outlook, the market faces several restraints and challenges:

Drug Shortages

Recent shortages due to the cessation of operations by key manufacturers like Akorn and the discontinuation of products by Sun Pharma have impacted market stability. However, other manufacturers such as American Regent, Fresenius Kabi, and Sagent continue to supply the market, mitigating some of these effects[5].

Regulatory Scrutiny

Increased regulatory scrutiny by bodies like the FDA can raise the cost of obtaining approvals for generic drug applications, potentially affecting market dynamics and the entry of new competitors[3].

Competitive Landscape

The competitive landscape of the chlorothiazide sodium injection market is characterized by the presence of several key players:

Major Players

Companies like Akorn, American Regent, Sagent, Sun Pharma, Fresenius Kabi, and Mylan are prominent in the market. These companies engage in various strategies such as new product launches, collaborations, mergers, and acquisitions to maintain their market position[1].

Generic Competition

The entry of generic competitors plays a significant role in shaping the market. Generic drug prices tend to fall as the number of competitors increases, approaching long-run marginal costs when there are eight or more competitors in the market[3].

Pharmacokinetics and Metabolism

Understanding the pharmacokinetics and metabolism of chlorothiazide sodium is crucial for its effective use. The drug is not metabolized and is rapidly eliminated by the kidneys, with 96% of an intravenous dose excreted unchanged in the urine within 23 hours. Its plasma half-life ranges from 45 to 120 minutes[2].

Indications and Usage

Chlorothiazide sodium injection is indicated for edema associated with various conditions, including congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. It is also useful in edema due to renal dysfunction such as nephrotic syndrome and acute glomerulonephritis[2].

Dosage and Administration

The drug should be reserved for patients unable to take oral medication or for emergency situations. The dosage should be individualized according to patient response, using the smallest necessary dose to achieve the required response. Intravenous use in infants and children is limited and not generally recommended[2].

Economic and Social Impact

The economic impact of the chlorothiazide sodium injection market is significant, with projected revenues indicating substantial growth. The social impact is equally important, as the availability of this drug improves the quality of life for patients suffering from edema and related conditions.

Market Opportunities and Challenges

Opportunities

  • Expanding Patient Population: The increasing prevalence of chronic conditions offers a growing market for chlorothiazide sodium injection.
  • Emerging Markets: Developing regions present opportunities for market expansion due to improving healthcare infrastructure and increasing demand for diuretic treatments[1].

Challenges

  • Regulatory Hurdles: Increased regulatory scrutiny can raise barriers to entry for new competitors.
  • Drug Shortages: Recent shortages highlight the need for stable supply chains and diversified manufacturing bases[5].

Porter's 5 Forces Analysis

Threat of New Entrants

The threat of new entrants is moderate due to regulatory barriers and the cost of obtaining FDA approvals. However, the potential for generic competition keeps the market dynamic[3].

Bargaining Power of Suppliers

The bargaining power of suppliers is relatively low, as the market is dominated by several key players who have significant control over the supply chain[1].

Bargaining Power of Buyers

The bargaining power of buyers is moderate, influenced by the availability of generic alternatives and the critical nature of the drug for patient treatment[3].

Threat of Substitute Products

The threat of substitute products is low, as chlorothiazide sodium injection is a specific treatment for certain conditions, although other diuretics may serve as substitutes in some cases[2].

Competitive Rivalry Among Existing Competitors

The competitive rivalry is high, driven by the presence of multiple key players and the entry of generic competitors, which leads to price competition and market share battles[1].

Key Takeaways

  • The chlorothiazide sodium injection market is projected to grow significantly from 2023 to 2031, driven by increasing demand and expanding patient populations.
  • The market is segmented by application, product, and geography, with key players like American Regent, Fresenius Kabi, and Sagent dominating the landscape.
  • Regulatory scrutiny and drug shortages are significant challenges, but the overall outlook remains positive.
  • The pharmacokinetics and metabolism of chlorothiazide sodium highlight its rapid elimination and specific indications.
  • Market opportunities include expanding patient populations and emerging markets, while challenges include regulatory hurdles and supply chain stability.

Frequently Asked Questions (FAQs)

Q: What are the primary indications for chlorothiazide sodium injection? A: Chlorothiazide sodium injection is indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy, as well as in edema due to various forms of renal dysfunction[2].

Q: How does the pharmacokinetics of chlorothiazide sodium influence its use? A: Chlorothiazide sodium is not metabolized and is rapidly eliminated by the kidneys, with 96% of an intravenous dose excreted unchanged in the urine within 23 hours. Its plasma half-life ranges from 45 to 120 minutes[2].

Q: What are the key drivers of the chlorothiazide sodium injection market growth? A: The market growth is driven by the increasing prevalence of chronic conditions, advancements in healthcare infrastructure, and the growing geriatric population[1][4].

Q: How does the competitive landscape of the chlorothiazide sodium injection market look? A: The market is competitive with key players like American Regent, Fresenius Kabi, and Sagent. Generic competition also plays a significant role in shaping the market dynamics[1][3].

Q: What are the potential challenges facing the chlorothiazide sodium injection market? A: The market faces challenges such as drug shortages, regulatory scrutiny, and the need for stable supply chains and diversified manufacturing bases[5].

Sources:

  1. Market Research Intellect - Chlorothiazide Sodium Injection Market Size and Forecast[1].
  2. Fresenius Kabi USA - Chlorothiazide Sodium for Injection, USP[2].
  3. Federal Trade Commission - Generic Drug Industry Dynamics[3].
  4. DataIntelo - Global Chlorothiazide Sodium Injection Market Research Report 2032[4].
  5. American Society of Health-System Pharmacists (ASHP) - Drug Shortage Detail: Chlorothiazide Sodium Injection[5].

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