Chlordiazepoxide hydrochloride - Generic Drug Details

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

Chlordiazepoxide hydrochloride is the generic ingredient in seven branded drugs marketed by Abbott, Rachelle, 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, Bausch, Valeant Pharm Intl, Alra, 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 ninety-three NDAs. Additional information is available in the individual branded drug profile pages.

There are two drug master file entries for chlordiazepoxide hydrochloride. Fourteen suppliers are listed for this compound.

Summary for chlordiazepoxide hydrochloride

US Patents:	0
Tradenames:	7
Applicants:	38
NDAs:	93
Drug Master File Entries:	2
Finished Product Suppliers / Packagers:	14
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	8
What excipients (inactive ingredients) are in chlordiazepoxide hydrochloride?	chlordiazepoxide hydrochloride excipients list
DailyMed Link:	chlordiazepoxide hydrochloride at DailyMed

Recent Clinical Trials for chlordiazepoxide hydrochloride

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

Sponsor	Phase
Mayo Clinic	Phase 4
Oregon Health and Science University	Phase 2
Chang Gung Memorial Hospital	Phase 2/Phase 3

See all chlordiazepoxide hydrochloride clinical trials

Pharmacology for chlordiazepoxide hydrochloride

Drug Class

Benzodiazepine

Anatomical Therapeutic Chemical (ATC) Classes for chlordiazepoxide hydrochloride

N05BA	Benzodiazepine derivatives
N05B	ANXIOLYTICS
N05	PSYCHOLEPTICS
N	Nervous system

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
Rachelle	CHLORDIAZACHEL	chlordiazepoxide hydrochloride	CAPSULE;ORAL	084639-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Torrent	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	chlordiazepoxide hydrochloride; clidinium bromide	CAPSULE;ORAL	217385-001	Dec 14, 2023		DISCN	No	No
Halsey	CHLORDIAZEPOXIDE HYDROCHLORIDE	chlordiazepoxide hydrochloride	CAPSULE;ORAL	085339-001	Approved Prior to Jan 1, 1982		DISCN	No	No

Expired US Patents for chlordiazepoxide hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Valeant Pharm Intl	LIBRIUM	chlordiazepoxide hydrochloride	CAPSULE;ORAL	012249-002	Approved Prior to Jan 1, 1982
Bausch	LIBRIUM	chlordiazepoxide hydrochloride	INJECTABLE;INJECTION	012301-001	Approved Prior to Jan 1, 1982
Valeant Pharm Intl	LIBRIUM	chlordiazepoxide hydrochloride	CAPSULE;ORAL	012249-003	Approved Prior to Jan 1, 1982

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".