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Last Updated: December 22, 2024

CHLORDIAZEPOXIDE - Generic Drug Details


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What are the generic drug sources for chlordiazepoxide and what is the scope of patent protection?

Chlordiazepoxide is the generic ingredient in twelve branded drugs marketed by Valeant Pharm Intl, 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, Alra, Alembic, Alkem Labs Ltd, Amneal, Aurobindo Pharma Ltd, Corepharma, Dr Reddys, Micro Labs, Misemer, Nuvo Pharms Inc, Teva Pharms Usa, Torrent, Winder Labs Llc, and Roche, and is included in ninety-eight NDAs. Additional information is available in the individual branded drug profile pages.

There are nine drug master file entries for chlordiazepoxide.

Summary for CHLORDIAZEPOXIDE
US Patents:0
Tradenames:12
Applicants:39
NDAs:98
Drug Master File Entries: 9
Raw Ingredient (Bulk) Api Vendors: 48
Clinical Trials: 8
Patent Applications: 6,859
Drug Prices: Drug price trends for CHLORDIAZEPOXIDE
What excipients (inactive ingredients) are in CHLORDIAZEPOXIDE?CHLORDIAZEPOXIDE excipients list
DailyMed Link:CHLORDIAZEPOXIDE at DailyMed
Drug Prices for CHLORDIAZEPOXIDE

See drug prices for CHLORDIAZEPOXIDE

Recent Clinical Trials for CHLORDIAZEPOXIDE

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 clinical trials

Medical Subject Heading (MeSH) Categories for CHLORDIAZEPOXIDE
Anatomical Therapeutic Chemical (ATC) Classes for CHLORDIAZEPOXIDE

US Patents and Regulatory Information for CHLORDIAZEPOXIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ascot CHLORDIAZEPOXIDE HYDROCHLORIDE chlordiazepoxide hydrochloride CAPSULE;ORAL 087524-001 Jan 7, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Roche MENRIUM 10-4 chlordiazepoxide; estrogens, esterified TABLET;ORAL 014740-006 Approved Prior to Jan 1, 1982 DISCN No No ⤷  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
Vangard CHLORDIAZEPOXIDE HYDROCHLORIDE chlordiazepoxide hydrochloride CAPSULE;ORAL 088130-001 Mar 28, 1983 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Upsher Smith Labs CHLORDIAZEPOXIDE HYDROCHLORIDE chlordiazepoxide hydrochloride CAPSULE;ORAL 084823-001 Approved Prior to Jan 1, 1982 DISCN 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
Vangard CHLORDIAZEPOXIDE HYDROCHLORIDE chlordiazepoxide hydrochloride CAPSULE;ORAL 088129-001 Mar 28, 1983 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 Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Chlordiazepoxide

Introduction to Chlordiazepoxide

Chlordiazepoxide, commonly known by its brand name Librium, is the first discovered benzodiazepine and has been a significant advancement in psychiatric medication since its approval by the FDA in 1960. It is used to treat anxiety disorders, preoperative anxiety, and the withdrawal symptoms of acute alcoholism[2][5].

Market Size and Projections

The market for chlordiazepoxide hydrochloride is experiencing steady growth. As of 2023, the market size was valued at USD 472.8 million 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 chlordiazepoxide hydrochloride market is segmented based on several factors:

  • Type: This includes tablets, capsules, oral solutions, injections, and disintegrating tablets.
  • Application: The primary applications are in the treatment of anxiety disorders, alcohol withdrawal symptoms, sedation, and insomnia.
  • Geographical Regions: The market is analyzed across 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 global prevalence of anxiety-related illnesses and the de-stigmatization of seeking mental health treatment are significant drivers. Anxiety disorders are more common among the elderly, further increasing demand[1][3][4].
  • Expansion of Healthcare Access: The development of healthcare systems and easier access to drugs in emerging nations contribute to market growth. The availability of generic versions of chlordiazepoxide has made the medication more economical and accessible[1][3].
  • Research and Development: Ongoing R&D activities aimed at improving the safety and efficacy of chlordiazepoxide also fuel market expansion[1].

Regional Market Dynamics

North America and Europe

These regions currently dominate the global benzodiazepine drugs market, including chlordiazepoxide, due to high healthcare expenditure and widespread prescription patterns. The U.S. accounts for a significant share of the market, driven by the presence of major pharmaceutical companies and a high number of prescription drug sales[3][4].

Asia-Pacific

The Asia-Pacific region is emerging as a key growth area due to rising living standards, a growing geriatric population, and improving access to healthcare in countries like China and India. Regional pharmaceutical companies are investing in the development of novel delivery systems and generics, capitalizing on the unmet needs in these markets[3][4].

Distribution Channels

The market is segmented into hospital pharmacies, retail pharmacies, and online pharmacies. Hospital pharmacies hold a significant market share due to their comprehensive formularies, diagnostic services, and integrated healthcare infrastructure, which simplify access and optimize treatment adherence and compliance[3][4].

Challenges and Concerns

Despite the growth, the market faces several challenges:

  • Dependence and Abuse Potential: Non-medical use of chlordiazepoxide can lead to physical and psychological dependence, which can hamper market growth. The risk of addiction and withdrawal symptoms upon discontinuation is a significant concern[2][5].
  • Side Effects: High doses of chlordiazepoxide can result in cognitive and physical impairments, such as memory loss, lack of coordination, and slowed response times, affecting daily functioning[5].
  • Regulatory and Safety Issues: Pricing pressures from regulatory reforms and the lack of stringent regulations in some Asian markets can raise safety concerns and impact market growth[3][4].

Financial Trajectory

The financial trajectory of the chlordiazepoxide hydrochloride market is positive, driven by the increasing demand for effective treatments for anxiety and related disorders. Here are some key financial indicators:

  • Market Value: The market was valued at USD 472.8 million in 2023 and is expected to reach USD 652.8 million by 2031[1].
  • CAGR: The market is growing at a CAGR of 3.6% from 2024 to 2031[1].
  • Revenue Streams: The revenue is generated through the sale of various formulations of chlordiazepoxide, including tablets, capsules, and oral solutions, across different geographical regions[1].

Competitive Landscape

The market for chlordiazepoxide hydrochloride includes both established and emerging players. The report provides extensive lists of prominent companies, their market entry year, and various market-related factors. Key players are focused on product approvals, generic versions, and R&D activities to enhance their market presence[1].

Key Takeaways

  • Growing Demand: The market is driven by the increasing prevalence of anxiety disorders and the need for effective pharmacological interventions.
  • Regional Growth: North America and Europe dominate the market, but the Asia-Pacific region is emerging as a significant growth area.
  • Challenges: Dependence and abuse potential, side effects, and regulatory issues are key challenges.
  • Financial Growth: The market is expected to grow at a CAGR of 3.6% from 2024 to 2031.

FAQs

What is chlordiazepoxide used for?

Chlordiazepoxide is used to treat anxiety disorders, preoperative anxiety, and the withdrawal symptoms of acute alcoholism. It is also used in combination with other medications for conditions like moderate to severe depression and gastrointestinal disorders[2][5].

What are the side effects of chlordiazepoxide?

High doses of chlordiazepoxide can result in cognitive and physical impairments, such as memory loss, lack of coordination, and slowed response times. Non-medical use can lead to physical and psychological dependence[2][5].

How is the chlordiazepoxide market segmented?

The market is segmented based on type (tablets, capsules, oral solutions, injections, disintegrating tablets), application (anxiety disorders, alcohol withdrawal symptoms, sedation, insomnia), and geographical regions (North America, Europe, Asia-Pacific, South America, Middle-East and Africa)[1].

What is the projected market size of chlordiazepoxide hydrochloride by 2031?

The market size is expected to reach USD 652.8 million by 2031, growing at a CAGR of 3.6% from 2024 to 2031[1].

Which regions are driving the growth of the chlordiazepoxide market?

North America and Europe currently dominate the market, but the Asia-Pacific region is emerging as a significant growth area due to rising living standards and improving access to healthcare[3][4].

Sources

  1. Market Research Intellect: Global Chlordiazepoxide Hydrochloride Market Size and Projections[1].
  2. DrugBank: Chlordiazepoxide: Uses, Interactions, Mechanism of Action[2].
  3. Coherent Market Insights: Benzodiazepine Drugs Market - Price, Size, Share & Growth[3].
  4. Grand View Research: Benzodiazepine Drugs Market Size And Share Report, 2030[4].
  5. Landmark Recovery: What is Chlordiazepoxide? A Guide to Librium[5].

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