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Last Updated: December 22, 2024

CHLORTHALIDONE; RESERPINE - Generic Drug Details


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What are the generic sources for chlorthalidone; reserpine and what is the scope of patent protection?

Chlorthalidone; reserpine is the generic ingredient in two branded drugs marketed by Sanofi Aventis Us and is included in one NDA. Additional information is available in the individual branded drug profile pages.

Summary for CHLORTHALIDONE; RESERPINE
US Patents:0
Tradenames:2
Applicants:1
NDAs:1
Clinical Trials: 3
DailyMed Link:CHLORTHALIDONE; RESERPINE at DailyMed
Recent Clinical Trials for CHLORTHALIDONE; RESERPINE

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

SponsorPhase
US Department of Veterans Affairs
VA Office of Research and Development
National Heart, Lung, and Blood Institute (NHLBI)Phase 3

See all CHLORTHALIDONE; RESERPINE clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for CHLORTHALIDONE; RESERPINE

US Patents and Regulatory Information for CHLORTHALIDONE; RESERPINE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sanofi Aventis Us DEMI-REGROTON chlorthalidone; reserpine TABLET;ORAL 015103-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Sanofi Aventis Us REGROTON chlorthalidone; reserpine TABLET;ORAL 015103-001 Approved Prior to Jan 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

CHLORTHALIDONE; RESERPINE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Chlorthalidone and Reserpine

Introduction

Chlorthalidone and reserpine are two significant medications in the pharmaceutical industry, each with its own market dynamics and financial trajectories. This article delves into the current market situation, growth prospects, and financial aspects of these drugs.

Chlorthalidone Market Dynamics

Established Position in Hypertension Treatment

Chlorthalidone is a well-established diuretic used primarily for the treatment of hypertension and edema. It has been a first-line treatment for these conditions due to its cost-effectiveness and long-lasting effects[3].

Market Segmentation

The chlorthalidone market is segmented based on application (research use and pharmaceutical industry), product purity (purity > 97% and purity 97%), and geographical regions (North America, Europe, Asia-Pacific, South America, and Middle-East and Africa)[1].

Global Market Size and Forecast

The global chlorthalidone API market is expected to grow significantly over the forecast period of 2024-2031. This growth is driven by the increasing prevalence of hypertension and the need for effective, cost-efficient treatments[1].

Key Players and Suppliers

The market includes several key players such as IPCA, KarpsChem, MENADIONA, and Triveni Interchem Private Limited, among others. There are also numerous suppliers listed for chlorthalidone, indicating a robust supply chain[1][3].

Clinical and Therapeutic Advantages

Chlorthalidone has been shown to be superior to hydrochlorothiazide (HCTZ) in certain clinical scenarios, particularly in reducing major adverse cardiovascular events (MACEs) and noncancer deaths in patients with prior myocardial infarction (MI) or stroke[5].

Financial Trajectory for Chlorthalidone

Revenue and Sales

The revenue generated from chlorthalidone is substantial, given its widespread use and inclusion in multiple branded drugs. The drug is part of sixty-eight New Drug Applications (NDAs) and has a large number of finished product suppliers and raw ingredient API vendors[3].

Investment Potential

The chlorthalidone market presents significant investment opportunities, particularly in regions where there is a high demand for affordable and effective antihypertensive medications. The stability and consistent demand for chlorthalidone make it an attractive option for long-term investment[1].

Reserpine Market Dynamics

Historical and Current Use

Reserpine is an alkaloid derived from the Rauwolfia plant, historically used in traditional medicine and later incorporated into modern pharmacology. It is primarily used as an antihypertensive and antipsychotic medication[2].

Global Importance

Reserpine holds substantial importance globally, especially in regions where access to newer medications is limited by economic constraints. It remains a cost-effective solution for managing hypertension and certain psychiatric conditions in developing countries[2].

Market Drivers

The global rise in hypertension and mental health disorders is a primary driver of the reserpine market. According to the World Health Organization (WHO), hypertension affects over 1 billion people worldwide, and mental health disorders account for a significant portion of the global disease burden[2].

Innovations and Research

Ongoing research is exploring new therapeutic applications of reserpine, including its potential use in neurodegenerative diseases and combination therapies. Innovations in drug delivery systems, such as extended-release formulations, are also driving growth in the reserpine market[2].

Financial Trajectory for Reserpine

Market Stability and Growth

The reserpine market is characterized by its stability and ongoing relevance, particularly in regions with limited access to newer drugs. The market's resilience is underscored by its affordability and the steady supply of the drug[2].

Investment Opportunities

The reserpine market presents numerous investment opportunities, especially in emerging markets where the demand for affordable healthcare solutions is rising. Strategic partnerships and innovations in drug delivery are driving investment interest in this market[2].

Revenue and Demand

The demand for reserpine is consistent, driven by its use in managing hypertension and mental health disorders. The drug's long-standing presence in the market ensures a steady revenue stream, making it an appealing option for investors[2].

Comparative Analysis of Chlorthalidone and Reserpine Markets

Market Size and Growth

Both markets are expected to grow, but the chlorthalidone market is anticipated to gain significant shares in the forecasted period due to its broader application and the increasing prevalence of hypertension[1].

Geographical Distribution

Both drugs have a global presence, but chlorthalidone is more widely used across various regions, including North America, Europe, and Asia-Pacific. Reserpine, however, is more prominent in developing countries due to its cost-effectiveness[1][2].

Therapeutic Advantages

Chlorthalidone has shown superior cardiovascular outcomes in certain patient groups compared to HCTZ, while reserpine's unique mechanism of action makes it effective in managing hypertension and psychiatric conditions, especially in resource-limited settings[5][2].

Key Takeaways

  • Chlorthalidone is a first-line treatment for hypertension and edema, with a growing market driven by its cost-effectiveness and superior clinical outcomes in certain patient groups.
  • Reserpine remains a vital medication for hypertension and mental health disorders, particularly in developing countries, due to its affordability and steady supply.
  • Both markets present significant investment opportunities, driven by the increasing demand for effective and affordable treatments.
  • Innovations in drug delivery and ongoing research into new therapeutic applications are key drivers for growth in both markets.

FAQs

Q: What are the primary applications of chlorthalidone?

A: Chlorthalidone is primarily used for the treatment of hypertension and edema.

Q: Why is reserpine still relevant in modern pharmacology?

A: Reserpine remains relevant due to its affordability and effectiveness in managing hypertension and certain psychiatric conditions, especially in regions with limited access to newer medications.

Q: What are the key drivers of the chlorthalidone market?

A: The key drivers include the increasing prevalence of hypertension, its cost-effectiveness, and superior clinical outcomes compared to other diuretics like HCTZ.

Q: How does reserpine compare to newer antihypertensive medications?

A: Reserpine is often preferred in resource-limited settings due to its affordability and long-standing presence in the market, despite the advent of newer medications.

Q: What are the investment opportunities in the chlorthalidone and reserpine markets?

A: Both markets offer significant investment opportunities, particularly in emerging markets where there is a high demand for affordable and effective treatments.

Sources

  1. Market Research Intellect, "Global Chlorthalidone API Market Size and Forecast", December 2024.
  2. Market Research Intellect, "Reserpine Market Sees Growth Amid Rising Demand in Pharma and Healthcare", August 19, 2024.
  3. DrugPatentWatch, "Generic CHLORTHALIDONE INN entry, pharmaceutical patent and suppliers".
  4. Drugs.com, "Reserpine: Package Insert / Prescribing Information".
  5. JAMA Network Open, "Chlorthalidone vs Hydrochlorothiazide for Hypertension Treatment After Myocardial Infarction or Stroke: A Secondary Analysis of a Randomized Clinical Trial", May 14, 2024.

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