You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: December 21, 2024

CHLORDIAZEPOXIDE HYDROCHLORIDE Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


Which patents cover Chlordiazepoxide Hydrochloride, and what generic alternatives are available?

Chlordiazepoxide Hydrochloride is a drug marketed by Ascot, Barr, Chartwell Rx, Ferrante, Halsey, Impax Labs, Ivax Sub Teva Pharms, Lederle, Mast Mm, Mylan, Parke Davis, Pioneer Pharms, Purepac Pharm, Roxane, Superpharm, Teva, Upsher Smith Labs, Usl Pharma, Vangard, Watson Labs, West Ward, Alembic, Alkem Labs Ltd, Amneal, Aurobindo Pharma Ltd, Corepharma, Dr Reddys, Micro Labs, Misemer, Nuvo Pharms Inc, Teva Pharms Usa, Torrent, and Winder Labs Llc. and is included in seventy-seven NDAs.

The generic ingredient in CHLORDIAZEPOXIDE HYDROCHLORIDE is chlordiazepoxide hydrochloride; clidinium bromide. There are nine drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the chlordiazepoxide hydrochloride; clidinium bromide profile page.

AI Research Assistant
Questions you can ask:
  • What is the 5 year forecast for CHLORDIAZEPOXIDE HYDROCHLORIDE?
  • What are the global sales for CHLORDIAZEPOXIDE HYDROCHLORIDE?
  • What is Average Wholesale Price for CHLORDIAZEPOXIDE HYDROCHLORIDE?
Summary for CHLORDIAZEPOXIDE HYDROCHLORIDE
Drug patent expirations by year for CHLORDIAZEPOXIDE HYDROCHLORIDE
Recent Clinical Trials for CHLORDIAZEPOXIDE HYDROCHLORIDE

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

SponsorPhase
Mayo ClinicPhase 4
Oregon Health and Science UniversityPhase 2
Taipei City HospitalPhase 2/Phase 3

See all CHLORDIAZEPOXIDE HYDROCHLORIDE clinical trials

Pharmacology for CHLORDIAZEPOXIDE HYDROCHLORIDE
Drug ClassBenzodiazepine
Anatomical Therapeutic Chemical (ATC) Classes for CHLORDIAZEPOXIDE HYDROCHLORIDE

US Patents and Regulatory Information for CHLORDIAZEPOXIDE HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Micro Labs CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE chlordiazepoxide hydrochloride; clidinium bromide CAPSULE;ORAL 215835-001 Jul 19, 2022 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Roxane CHLORDIAZEPOXIDE HYDROCHLORIDE chlordiazepoxide hydrochloride CAPSULE;ORAL 084700-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Parke Davis CHLORDIAZEPOXIDE HYDROCHLORIDE chlordiazepoxide hydrochloride CAPSULE;ORAL 085163-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Teva CHLORDIAZEPOXIDE HYDROCHLORIDE chlordiazepoxide hydrochloride CAPSULE;ORAL 088707-001 Jan 18, 1985 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Watson Labs CHLORDIAZEPOXIDE HYDROCHLORIDE chlordiazepoxide hydrochloride CAPSULE;ORAL 086294-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Superpharm CHLORDIAZEPOXIDE HYDROCHLORIDE chlordiazepoxide hydrochloride CAPSULE;ORAL 088988-001 Apr 25, 1985 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Upsher Smith Labs CHLORDIAZEPOXIDE HYDROCHLORIDE chlordiazepoxide hydrochloride CAPSULE;ORAL 084919-001 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

CHLORDIAZEPOXIDE HYDROCHLORIDE 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].

Market Segmentation

The market is segmented based on type, application, and geography. The types include tablets, capsules, oral solutions, injections, and disintegrating tablets. Applications span anxiety disorders, alcohol withdrawal symptoms, sedation, and insomnia. Geographically, the market is divided into North America, Europe, Asia-Pacific, South America, and the Middle-East and Africa[1].

Driving Factors

Several factors are driving the growth of the chlordiazepoxide hydrochloride market:

Increasing Prevalence of Anxiety Disorders

The rising prevalence of anxiety-related illnesses globally is a significant driver. As mental health awareness increases and the stigma around seeking treatment decreases, more people are seeking medical help, leading to higher demand for effective treatments like chlordiazepoxide hydrochloride[1].

Elderly Population

The elderly population is particularly vulnerable to anxiety disorders and alcohol withdrawal symptoms, further increasing the demand for this medication[1].

Generic Versions and Healthcare Access

The availability of generic versions of chlordiazepoxide hydrochloride and the expansion of healthcare access in emerging nations have made the drug more affordable and accessible. This has contributed significantly to the market's growth[1].

Research and Development

Ongoing research and development activities aimed at improving the safety and efficacy of chlordiazepoxide hydrochloride also support market expansion[1].

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[3].

Challenges and Risks

Despite the market growth, there are several challenges and risks associated with chlordiazepoxide hydrochloride:

Addiction and Dependence

Chlordiazepoxide hydrochloride is highly addictive, and its use can lead to tolerance and dependence. This necessitates careful prescribing practices, especially for recovering addicts[4].

Side Effects

The medication has various side effects, ranging from mild symptoms like sleepiness and muscle weakness to more serious issues such as headache, vertigo, and low blood pressure. Combining it with other substances like alcohol or opioids can pose a severe risk of overdose[4].

Financial and Legal Implications

Maintaining a habit of chlordiazepoxide hydrochloride can lead to financial strain and legal issues, including impaired judgment and potential drug-driving charges[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.

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[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.

Regulatory Environment

The regulatory environment plays a crucial role in the market dynamics of chlordiazepoxide hydrochloride. Approvals from regulatory bodies like the U.S. Food and Drug Administration (USFDA) are essential for the launch of new products, including generic versions[3].

Conclusion

The market for chlordiazepoxide hydrochloride is poised for steady growth driven by increasing demand for anxiety treatments, the elderly population's needs, and the expansion of healthcare access. However, it is crucial to address the challenges associated with addiction, side effects, and regulatory compliance to ensure sustainable market growth.

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[4].

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".
  2. Linwood House, "Librium: The quiet addiction".
  3. Pharmacy Times, "Dr. Reddy's Laboratories Announces Launch of Chlordiazepoxide Hydrochloride, Clidinium Bromide Capsules, USP in the US Market".
  4. UKAT, "Chlordiazepoxide for detox treatment".

More… ↓

⤷  Subscribe

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.