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Last Updated: December 22, 2024

CHLORDIAZACHEL Drug Patent Profile


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

Chlordiazachel is a drug marketed by Rachelle and is included in three NDAs.

The generic ingredient in CHLORDIAZACHEL is chlordiazepoxide hydrochloride. There are nine drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the chlordiazepoxide hydrochloride profile page.

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Summary for CHLORDIAZACHEL
Drug patent expirations by year for CHLORDIAZACHEL

US Patents and Regulatory Information for CHLORDIAZACHEL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Rachelle CHLORDIAZACHEL chlordiazepoxide hydrochloride CAPSULE;ORAL 085086-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Rachelle CHLORDIAZACHEL chlordiazepoxide hydrochloride CAPSULE;ORAL 084639-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Rachelle CHLORDIAZACHEL chlordiazepoxide hydrochloride CAPSULE;ORAL 085087-001 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

CHLORDIAZACHEL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Chlordiazepoxide Hydrochloride

Introduction

Chlordiazepoxide hydrochloride, commonly known by its brand name Librium, is a benzodiazepine used primarily for the treatment of anxiety disorders, alcohol withdrawal symptoms, sedation, and insomnia. This article delves into the market dynamics and financial trajectory of this medication, highlighting key factors driving its market growth and potential challenges.

Market Size and Projections

The global market for chlordiazepoxide hydrochloride was valued at USD 472.8 million in 2023 and is projected to reach USD 652.8 million by 2031, growing at a Compound Annual Growth Rate (CAGR) of 3.6% from 2024 to 2031[1][2].

Key Drivers of Market Growth

Increasing Prevalence of Anxiety Disorders

The rising prevalence of anxiety disorders and related illnesses globally is a significant driver of the market. As mental health awareness increases, more individuals are seeking treatment, which in turn boosts the demand for chlordiazepoxide hydrochloride[1].

Elderly Population

The elderly population is particularly vulnerable to anxiety and related conditions, further fueling the demand for this medication. The aging population in many countries is expected to continue driving market growth[1].

Generic Versions and Healthcare Access

The release of generic versions of chlordiazepoxide hydrochloride has made the drug more economical and accessible. Additionally, the expansion of healthcare services in emerging nations has increased the availability of the drug, contributing to market expansion[1].

Regulatory Environment

Approvals from regulatory bodies such as the U.S. Food and Drug Administration (USFDA) are crucial for the launch of new products, including generic versions. A favorable regulatory environment supports the market's growth by ensuring the safety and efficacy of the drug[2].

Key Players

The market is dominated by several key players, including Mylan N.V. (Viatris), Teva Pharmaceutical Industries Ltd., Sun Pharmaceutical Industries Ltd., Cadila Healthcare Ltd. (Zydus Cadila), Apotex Inc., Sandoz International GmbH (Novartis AG), and Dr. Reddy’s Laboratories Ltd. These companies play a crucial role in the production and distribution of chlordiazepoxide hydrochloride products[1].

Recent Market Developments

Dr. Reddy’s Laboratories recently launched a generic version of chlordiazepoxide hydrochloride and clidinium bromide capsules in the US market, which is a therapeutic equivalent to Librax®. This launch has contributed to the market's growth, with the Librax® brand and generic market having U.S. sales of approximately $105.9 million in the twelve months ending in July 2021[2].

Regional Market Analysis

The market is geographically diverse, with North America, Europe, and Asia-Pacific being significant regions. The growth in these regions is driven by the increasing awareness of mental health, the availability of generic versions, and the expansion of healthcare services. For instance, the North American market is expected to grow significantly due to high healthcare spending and advanced healthcare infrastructure[4].

Competitive Landscape

The competitive landscape of the chlordiazepoxide hydrochloride market is characterized by the presence of both established and emerging players. Companies are focusing on developing generic versions and improving the safety and efficacy of the drug to gain market share. The competition is intense, with multiple manufacturers vying for market dominance through innovative strategies and product developments[1].

Economic Impact

The economic impact of the chlordiazepoxide hydrochloride market is substantial, with the market size expected to grow significantly over the forecast period. The affordability and accessibility of the drug, especially in emerging markets, are key economic drivers. As the market expands, it is likely to create new job opportunities and stimulate economic growth in the pharmaceutical sector[1].

Challenges and Risks

Addiction and Side Effects

Chlordiazepoxide hydrochloride is highly addictive and can lead to tolerance and dependence. This poses a significant challenge to its long-term use and market sustainability. Additionally, the drug has serious side effects, which can impact its adoption and regulatory approval[2].

Regulatory Compliance

Ensuring compliance with regulatory standards is crucial for the market's growth. Any non-compliance can lead to product recalls, fines, and damage to the company's reputation, which can negatively impact the market[2].

Recent Clinical Trials

Several clinical trials are ongoing to improve the safety and efficacy of chlordiazepoxide hydrochloride. For example, the Mayo Clinic, Oregon Health and Science University, and Chang Gung Memorial Hospital are conducting Phase 2 and Phase 4 trials to explore new applications and improve existing treatments[2].

Impact of Global Events

COVID-19 and Russia-Ukraine War

The COVID-19 pandemic and the Russia-Ukraine War have had significant impacts on the global pharmaceutical market, including the chlordiazepoxide hydrochloride market. These events have affected supply chains, consumer behavior, and overall market dynamics. However, the demand for chlordiazepoxide hydrochloride has remained relatively stable due to its essential nature in treating anxiety and related conditions[4].

Technological Trends and New Product Developments

Ongoing research and development activities are focused on improving the safety and efficacy of chlordiazepoxide hydrochloride. New product developments, such as extended-release formulations and combination therapies, are expected to enhance the market's growth potential[1].

Consumer Trends

The de-stigmatization of seeking treatment for mental health issues has led to an increase in the number of people seeking medical help for anxiety disorders. This trend is expected to continue, driving the demand for chlordiazepoxide hydrochloride and other related medications[1].

Market Segmentation

The market is segmented based on application, dosage, and geography. The primary applications include the treatment of anxiety disorders, alcohol withdrawal symptoms, sedation, and insomnia. The market is also segmented into different dosage forms, such as capsules and tablets, which cater to various patient needs[4].

Financial Performance

The financial performance of the chlordiazepoxide hydrochloride market is robust, with a projected growth rate of 3.6% CAGR from 2024 to 2031. The market's financial trajectory is influenced by factors such as the launch of new products, expansion into emerging markets, and the increasing prevalence of anxiety disorders[1].

Key Takeaways

  • The global chlordiazepoxide hydrochloride market is projected to reach USD 652.8 million by 2031.
  • The market is driven by the increasing prevalence of anxiety disorders and the elderly population's needs.
  • Generic versions and expanded healthcare access in emerging nations are key growth factors.
  • The medication has significant risks, including addiction and serious side effects.
  • Regulatory approvals and ongoing research are critical for market expansion.

FAQs

What is the current market size of chlordiazepoxide hydrochloride?

The current market size of chlordiazepoxide hydrochloride was valued at USD 472.8 million in 2023[1].

What is the projected growth rate of the chlordiazepoxide hydrochloride market?

The market is expected to grow at a CAGR of 3.6% from 2024 to 2031[1].

What are the primary applications of chlordiazepoxide hydrochloride?

The primary applications include the treatment of anxiety disorders, alcohol withdrawal symptoms, sedation, and insomnia[1].

Is chlordiazepoxide hydrochloride addictive?

Yes, chlordiazepoxide hydrochloride is highly addictive and can lead to tolerance and dependence[2].

Which companies are key players in the chlordiazepoxide hydrochloride market?

Key players include Mylan N.V. (Viatris), Teva Pharmaceutical Industries Ltd., Sun Pharmaceutical Industries Ltd., and Dr. Reddy’s Laboratories Ltd.[1].

Sources

  1. Market Research Intellect: Global Chlordiazepoxide Hydrochloride Market Size and Projections.
  2. Drug Patent Watch: CHLORDIAZEPOXIDE HYDROCHLORIDE - Generic Drug Details.
  3. IQVIA: Understanding the Dynamics of Drug Expenditure.
  4. Precision Reports: Global Chlordiazepoxide Market – Industry Reports.

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