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Last Updated: December 25, 2024

CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE Drug Patent Profile


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When do Chlordiazepoxide And Amitriptyline Hydrochloride patents expire, and when can generic versions of Chlordiazepoxide And Amitriptyline Hydrochloride launch?

Chlordiazepoxide And Amitriptyline Hydrochloride is a drug marketed by Anda Repository, Chartwell Rx, Heritage Pharma, Micro Labs, Mylan Pharms Inc, and Usl Pharma. and is included in ten NDAs.

The generic ingredient in CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE is amitriptyline hydrochloride; chlordiazepoxide. There are thirteen drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the amitriptyline hydrochloride; chlordiazepoxide profile page.

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Summary for CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE
Drug patent expirations by year for CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE
Recent Clinical Trials for CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE

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SponsorPhase
Federal University of São PauloPhase 4
Fundação de Amparo à Pesquisa do Estado de São PauloPhase 4

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Pharmacology for CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE

US Patents and Regulatory Information for CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Anda Repository CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE amitriptyline hydrochloride; chlordiazepoxide TABLET;ORAL 070765-001 Dec 10, 1986 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Micro Labs CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE amitriptyline hydrochloride; chlordiazepoxide TABLET;ORAL 211925-001 Feb 2, 2022 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Chartwell Rx CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE amitriptyline hydrochloride; chlordiazepoxide TABLET;ORAL 072278-001 May 9, 1988 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 AND AMITRIPTYLINE HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Chlordiazepoxide and Amitriptyline Hydrochloride

Introduction

Chlordiazepoxide and amitriptyline hydrochloride, a combination drug used to treat moderate to severe depression associated with anxiety, is a significant player in the psychiatric medication market. This article delves into the market dynamics and financial trajectory of this drug, highlighting key factors influencing its market performance.

Market Size and Growth

The global amitriptyline market, which includes chlordiazepoxide and amitriptyline hydrochloride, is estimated to be valued at US$ 607.0 million in 2023. This market is expected to exhibit a Compound Annual Growth Rate (CAGR) of 5.6% during the forecast period from 2023 to 2030[3].

Drivers of Market Growth

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

Increasing Prevalence of Mental Disorders

The rise in mental health issues such as depression and anxiety is a significant driver. According to the World Health Organization (WHO), more than 150 million people in Europe alone were living with mental disorders in 2021[3].

Product Approvals and Regulatory Support

Regulatory approvals from authorities like the U.S. FDA have boosted the market. For instance, Unichem Laboratories Ltd. received Abbreviated New Drug Application (ANDA) approval for its amitriptyline HCl tablets in 2021, which has contributed to market growth[3].

Impact of COVID-19

The COVID-19 pandemic has had a positive impact on the market due to the increased use of amitriptyline to treat post-COVID-19 symptoms such as headaches and migraines. The pandemic has also exacerbated mental health issues, further driving demand for these medications[3].

Regional Market Performance

The market performance varies by region:

North America

North America dominates the market, holding a 34.8% market share. This is attributed to the presence of major pharmaceutical companies such as Accord Healthcare Inc., Viatris Inc., and Sun Pharmaceutical Industries Inc.[3].

Europe

Europe is the second-largest market, driven by an increase in mental health disorders. The region's market growth is supported by the high prevalence of mental health issues and the presence of key market players[3].

Asia Pacific

In the Asia Pacific region, the hospital pharmacies segment holds a dominant position due to the increasing number of hospitals and hospital pharmacies, particularly in countries like China[3].

Distribution Channels

The distribution channel segment plays a crucial role in the market dynamics. In the U.S., there are roughly 60,000 retail pharmacies, with one-third being independent pharmacies and two-thirds being retail chains, supermarkets, and mass retailers. This extensive network of pharmacies facilitates the distribution and accessibility of chlordiazepoxide and amitriptyline hydrochloride tablets[3].

Challenges and Restraints

Despite the growth, there are several challenges that could impact the market:

Side Effects and Safety Concerns

The side effects associated with amitriptyline, such as nausea, vomiting, drowsiness, and others, can shift patient preferences to alternative treatments. Serious side effects like severe allergic reactions, glaucoma, heart rhythm changes, blood disorders, and liver damage also pose significant risks[3][4].

Dependence and Withdrawal

The risk of physical dependence and withdrawal reactions associated with benzodiazepines like chlordiazepoxide is a critical concern. Abrupt discontinuation or rapid dosage reduction can lead to life-threatening withdrawal reactions[1].

Competitive Landscape

The market for chlordiazepoxide and amitriptyline hydrochloride is competitive, with several key players:

Major Pharmaceutical Companies

Companies like Mylan Pharmaceuticals Inc., Accord Healthcare Inc., Viatris Inc., and Sun Pharmaceutical Industries Inc. are major players in this market. These companies invest heavily in research and development, and their market presence is significant[1][3].

Financial Performance

The financial performance of the drug is closely tied to its market size and growth. With a projected CAGR of 5.6%, the market is expected to grow substantially over the forecast period. The financial trajectory is influenced by factors such as product approvals, regulatory support, and the increasing prevalence of mental health disorders.

Key Takeaways

  • The global amitriptyline market, including chlordiazepoxide and amitriptyline hydrochloride, is valued at US$ 607.0 million in 2023 and is expected to grow at a CAGR of 5.6% until 2030.
  • The market is driven by the increasing prevalence of mental disorders, product approvals, and the impact of the COVID-19 pandemic.
  • North America and Europe are the dominant regions, with significant contributions from major pharmaceutical companies.
  • Despite growth, the market faces challenges such as side effects, safety concerns, and the risk of dependence and withdrawal.

FAQs

1. What is chlordiazepoxide and amitriptyline hydrochloride used for? Chlordiazepoxide and amitriptyline hydrochloride is used to treat depression in people who also have anxiety. It combines a benzodiazepine (chlordiazepoxide) for anxiety relief and a tricyclic antidepressant (amitriptyline) to treat depression[1][4].

2. What are the common side effects of chlordiazepoxide and amitriptyline hydrochloride? Common side effects include drowsiness, dizziness, blurred vision, constipation, dry mouth, and bloating. Serious side effects can include severe allergic reactions, glaucoma, heart rhythm changes, blood disorders, and liver damage[4].

3. How does the COVID-19 pandemic impact the market for chlordiazepoxide and amitriptyline hydrochloride? The COVID-19 pandemic has had a positive impact on the market due to the increased use of amitriptyline to treat post-COVID-19 symptoms and the exacerbation of mental health issues[3].

4. Which regions dominate the market for chlordiazepoxide and amitriptyline hydrochloride? North America and Europe are the dominant regions, with North America holding a 34.8% market share and Europe being the second-largest market[3].

5. What are the major challenges facing the market for chlordiazepoxide and amitriptyline hydrochloride? Major challenges include side effects, safety concerns, the risk of physical dependence and withdrawal reactions, and the potential shift in patient preferences to alternative treatments due to these issues[1][3][4].

Cited Sources:

  1. DailyMed - Chlordiazepoxide and Amitriptyline Hydrochloride tablet, film coated[1].
  2. FDA - Amitriptyline hydrochloride; Chlordiazepoxide oral tablet[2].
  3. Coherent Market Insights - Amitriptyline Market Size, Trends and Forecast to 2030[3].
  4. WebMD - Chlordiazepoxide/Amitriptyline - Uses, Side Effects, and More[4].

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