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Last Updated: December 22, 2024

CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE - Generic Drug Details


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What are the generic drug sources for chlordiazepoxide hydrochloride; clidinium bromide and what is the scope of freedom to operate?

Chlordiazepoxide hydrochloride; clidinium bromide is the generic ingredient in two branded drugs marketed by Alembic, Alkem Labs Ltd, Amneal, Aurobindo Pharma Ltd, Chartwell Rx, Corepharma, Dr Reddys, Micro Labs, Misemer, Nuvo Pharms Inc, Teva Pharms Usa, Torrent, Winder Labs Llc, and Bausch, and is included in fourteen NDAs. Additional information is available in the individual branded drug profile pages.

Fifteen suppliers are listed for this compound.

Summary for CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE
Pharmacology for CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE
Anatomical Therapeutic Chemical (ATC) Classes for CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE

US Patents and Regulatory Information for CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bausch LIBRAX chlordiazepoxide hydrochloride; clidinium bromide CAPSULE;ORAL 012750-001 Approved Prior to Jan 1, 1982 AB RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Aurobindo Pharma Ltd CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE chlordiazepoxide hydrochloride; clidinium bromide CAPSULE;ORAL 216419-001 Sep 14, 2023 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Winder Labs Llc CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE chlordiazepoxide hydrochloride; clidinium bromide CAPSULE;ORAL 212344-001 Jul 8, 2024 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Chartwell Rx CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE chlordiazepoxide hydrochloride; clidinium bromide CAPSULE;ORAL 213530-001 Oct 20, 2020 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Alembic CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE chlordiazepoxide hydrochloride; clidinium bromide CAPSULE;ORAL 216969-001 Sep 15, 2023 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Dr Reddys CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE chlordiazepoxide hydrochloride; clidinium bromide CAPSULE;ORAL 214698-001 May 10, 2021 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Misemer CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE chlordiazepoxide hydrochloride; clidinium bromide CAPSULE;ORAL 210579-001 Jul 29, 2020 AB 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

CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Chlordiazepoxide Hydrochloride and Clidinium Bromide

Introduction

Chlordiazepoxide hydrochloride and clidinium bromide, a combination drug commonly known by the brand name Librax, is used to treat various gastrointestinal disorders. This article delves into the market dynamics, financial trajectory, and key factors influencing the demand and supply of this medication.

Market Overview

The market for chlordiazepoxide hydrochloride and clidinium bromide is part of the broader gastrointestinal drugs market, which is experiencing significant growth due to increasing prevalence of gastrointestinal illnesses such as peptic ulcers, irritable bowel syndrome (IBS), and enterocolitis[4,.

Current Market Size

As of the most recent data, the U.S. sales for Librax and its generic equivalents were approximately $105.9 million for the twelve months ending in July 2021[1].

Growth Projections

The clidinium bromide market, a key component of this combination drug, is expected to grow at a Compound Annual Growth Rate (CAGR) of 6% from 2024 to 2031, reaching a market size of USD 1.77 billion by 2031 from USD 1 billion in 2023[3].

Indications and Usage

Chlordiazepoxide hydrochloride and clidinium bromide are indicated for controlling emotional and somatic factors in gastrointestinal disorders. They are also used as adjunctive therapy in the treatment of peptic ulcers and IBS[2][4].

Therapeutic Benefits

  • Chlordiazepoxide Hydrochloride: A benzodiazepine that decreases abnormal electrical activity in the brain, providing anxiolytic and sedative effects.
  • Clidinium Bromide: An anticholinergic that helps to decrease stomach spasms and cramps, alleviating symptoms associated with gastrointestinal disorders[4].

Market Drivers

Increasing Prevalence of Gastrointestinal Illnesses

The growing prevalence of gastrointestinal illnesses such as IBS and peptic ulcers is a significant driver for the market. These conditions require effective antispasmodic treatments, which clidinium bromide provides[3].

Rising Awareness of Gastrointestinal Health

Increased awareness of gastrointestinal health issues and the importance of symptom management are driving the demand for this medication. Patients are more likely to seek medical treatment for their symptoms, leading to higher sales[3].

Advancements in Pharmaceutical Formulations

Improvements in pharmaceutical formulations and the acceptance of combination medicines are further boosting the market. These advancements cater to a wider range of patient needs, making the treatment more accessible and effective[3].

Aging Population and Expanding Healthcare Access

The aging global population, which is more prone to digestive problems, and expanding healthcare access in emerging nations are also contributing to market growth[3].

Market Challenges

Regulatory and Safety Concerns

The use of benzodiazepines, such as chlordiazepoxide hydrochloride, is associated with risks like physical dependence, withdrawal symptoms, and potential for abuse. These concerns necessitate careful regulation and monitoring, which can impact market dynamics[4].

Concomitant Use Risks

Concomitant use of benzodiazepines and opioids can result in profound sedation, respiratory depression, coma, and death, which is a significant safety concern and a challenge for the market[2].

Competitive Landscape

Generic Market Entry

The entry of generic versions, such as Dr. Reddy's Laboratories' launch of chlordiazepoxide hydrochloride and clidinium bromide capsules in the U.S. market, has increased competition. This has made the medication more affordable and accessible, contributing to market growth[1][5].

Major Market Players

Companies like Dr. Reddy's Laboratories, along with other pharmaceutical firms, are focusing on research and development to bring new and reliable products to the market. This competitive environment drives innovation and market expansion[5].

Financial Trajectory

Revenue Growth

The revenue from chlordiazepoxide hydrochloride and clidinium bromide is expected to grow steadily, driven by the increasing demand for gastrointestinal treatments. The market size for clidinium bromide alone is projected to reach USD 1.77 billion by 2031[3].

Cost and Pricing

The availability of generic alternatives has led to competitive pricing, making the treatment more affordable for patients. This has contributed to higher sales volumes and revenue growth[1].

Regional Market Analysis

North America

The North American market, particularly the U.S., is expected to hold a significant share due to increasing gastroesophageal reflux disease (GERD) and lifestyle changes leading to gastrointestinal problems. The trend towards self-medication in North America also increases the demand for over-the-counter and prescription digestive products[5].

Regulatory Environment

FDA Approvals

Regulatory approvals play a crucial role in the market. For instance, the FDA approval of generic versions of chlordiazepoxide hydrochloride and clidinium bromide capsules by Dr. Reddy's Laboratories has expanded the market. Similar approvals for other gastrointestinal treatments also contribute to market growth[1][5].

Future Outlook

Research and Development

Ongoing research into enhancing the therapeutic efficacy and safety of chlordiazepoxide hydrochloride and clidinium bromide will continue to drive market growth. Supportive regulatory measures and advancements in pharmaceutical formulations will also play a significant role[3].

Market Segmentation

The market is segmented based on end-use industry, product classification, and other pertinent segmentations. This thorough segmentation aids in optimizing marketing strategies and understanding the diverse needs of the market[3].

Key Takeaways

  • The market for chlordiazepoxide hydrochloride and clidinium bromide is driven by the increasing prevalence of gastrointestinal illnesses.
  • Advancements in pharmaceutical formulations and the acceptance of combination medicines are key drivers.
  • Regulatory and safety concerns, particularly related to benzodiazepine use, need careful management.
  • The entry of generic versions has increased competition and made the medication more affordable.
  • The North American market is significant due to lifestyle changes and increasing GERD.

FAQs

Q: What are the primary indications for chlordiazepoxide hydrochloride and clidinium bromide?

A: The combination is used to control emotional and somatic factors in gastrointestinal disorders, and as adjunctive therapy in the treatment of peptic ulcers and IBS[2][4].

Q: What are the potential risks associated with chlordiazepoxide hydrochloride?

A: Risks include physical dependence, withdrawal symptoms, and potential for abuse, especially when used concomitantly with opioids[2][4].

Q: How is the market for clidinium bromide expected to grow?

A: The market is expected to grow at a CAGR of 6% from 2024 to 2031, reaching USD 1.77 billion by 2031[3].

Q: Which regions are expected to contribute significantly to the market growth?

A: North America, particularly the U.S., is expected to hold a significant share due to increasing gastrointestinal problems and lifestyle changes[5].

Q: What role do generic versions play in the market?

A: Generic versions, such as those launched by Dr. Reddy's Laboratories, increase competition, make the medication more affordable, and contribute to market growth[1][5].

Sources

  1. Dr. Reddy's Laboratories Announces Launch of Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsules, USP - Pharmacy Times
  2. LIBRAX- chlordiazepoxide hydrochloride and clidinium bromide - TaperMD
  3. Global Clidinium Bromide Market Size and Projections - Market Research Intellect
  4. Chlordiazepoxide and Clidinium: MedlinePlus Drug Information - MedlinePlus
  5. Antacids Market Trends - Mordor Intelligence

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