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Last Updated: December 22, 2024

QUAZEPAM - Generic Drug Details


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

Quazepam is the generic ingredient in one branded drug marketed by Galt Pharms and is included in one NDA. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

There are two drug master file entries for quazepam. One supplier is listed for this compound.

Summary for QUAZEPAM
US Patents:1
Tradenames:1
Applicants:1
NDAs:1
Drug Master File Entries: 2
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 22
Clinical Trials: 1
What excipients (inactive ingredients) are in QUAZEPAM?QUAZEPAM excipients list
DailyMed Link:QUAZEPAM at DailyMed
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for QUAZEPAM
Generic Entry Date for QUAZEPAM*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for QUAZEPAM

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

SponsorPhase
Saint-Joseph UniversityPhase 3

See all QUAZEPAM clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for QUAZEPAM

US Patents and Regulatory Information for QUAZEPAM

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Galt Pharms DORAL quazepam TABLET;ORAL 018708-003 Feb 26, 1987 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Galt Pharms DORAL quazepam TABLET;ORAL 018708-001 Dec 27, 1985 RX Yes Yes ⤷  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

Expired US Patents for QUAZEPAM

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Galt Pharms DORAL quazepam TABLET;ORAL 018708-001 Dec 27, 1985 ⤷  Subscribe ⤷  Subscribe
Galt Pharms DORAL quazepam TABLET;ORAL 018708-003 Feb 26, 1987 ⤷  Subscribe ⤷  Subscribe
Galt Pharms DORAL quazepam TABLET;ORAL 018708-001 Dec 27, 1985 ⤷  Subscribe ⤷  Subscribe
Galt Pharms DORAL quazepam TABLET;ORAL 018708-001 Dec 27, 1985 ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

QUAZEPAM Market Analysis and Financial Projection Experimental

Benzodiazepine Drugs Market: Understanding the Dynamics and Financial Trajectory

Introduction to Benzodiazepine Drugs

Benzodiazepine drugs, including quazepam, are a class of psychoactive drugs known for their anxiolytic, hypnotic, muscle relaxant, and anticonvulsant properties. These drugs are widely used to treat anxiety disorders, insomnia, and other mental health conditions.

Global Benzodiazepine Drugs Market Overview

The global benzodiazepine drugs market is a significant segment within the pharmaceutical industry. Here are some key points about its current state and future projections:

Market Size and Growth

  • The global benzodiazepine drugs market was valued at US$ 2.35 billion in 2022 and is forecasted to grow at a Compound Annual Growth Rate (CAGR) of 2.8% to reach US$ 3.1 billion by 2032[1][3].

Regional Market Analysis

  • North America is the dominant region, accounting for approximately 37.2% of the global market share in 2021. This is due to the well-established healthcare infrastructure and high awareness of mental health in this region[1][3].
  • The Asia Pacific region is the fastest-growing market, driven by increasing prevalence of anxiety disorders, population growth, and improving healthcare infrastructure[1][3].

Product Segmentation

Alprazolam: The Dominant Product

  • Alprazolam holds the largest market share, approximately 29.6% in 2021, due to its effectiveness in treating anxiety and panic disorders. It is expected to exhibit a CAGR of 3% during the forecast period[1][3].

Other Key Products

  • Other significant products include clonazepam, diazepam, and lorazepam. Clonazepam is emerging as the fastest-growing segment, driven by its application in epilepsy treatment and rising awareness of panic disorders[1][3].

Distribution Channels

Hospital Pharmacies

  • Hospital pharmacies are the dominant distribution channel, providing acute care and managing patients with severe anxiety disorders and other conditions that require benzodiazepine medications[3].

Online and Retail Pharmacies

  • Online and retail pharmacies also play a role, especially with the increasing trend of online healthcare services and home delivery of medications[3].

Market Drivers

Growing Awareness and Diagnosis of Mental Health Conditions

  • The increasing prevalence of anxiety disorders, sleep-related conditions, and mental health awareness are driving the demand for benzodiazepine medications[3].

Aging Population and Sleep Disorders

  • An aging population and rising cases of sleep disorders are also contributing to the growth of the benzodiazepine drugs market[3].

Market Restraints

Regulatory Concerns and Guidelines

  • Regulatory authorities are imposing stricter guidelines to ensure the responsible use of benzodiazepine drugs, which can act as a restraint on market growth[3].

Availability of Alternative Treatment Options

  • The availability of alternative treatment options, such as non-benzodiazepine anxiolytics and antidepressants, can also impact the market negatively[3].

Financial Trajectory

Historical Growth

  • Between 2017 and 2021, the global benzodiazepine drugs market registered a CAGR of 2.7%. This growth was driven by the intensified use of anxiolytics and hypnotics, as well as investments in healthcare R&D[1].

Future Projections

  • The market is expected to continue growing at a CAGR of 2.8% from 2022 to 2032. This growth will be fueled by rising cases of mental disorders, urbanization, and extraordinary work pressure[1][3].

Competitive Landscape

Key Players

  • Major players in the benzodiazepine drugs market include Pfizer Inc., Akorn Inc, Hikma, Hameln Pharmaceutical, Accord, Troylab, Amneal Pharmaceuticals LLC, and Apotex Inc. These companies collectively hold a significant market share, around 24.6%[1].

Regional Opportunities

Asia Pacific: A Highly Opportunistic Market

  • The Asia Pacific region, particularly East Asia and South Asia, is becoming increasingly opportunistic due to the growing population, stressful lifestyles, and improving healthcare facilities. Government initiatives and the presence of generic manufacturers are also driving market growth in this region[1][3].

Pharmacologic Predictors and Response Trajectory

Early Improvement and Dose-Response Relationship

  • Studies have shown that benzodiazepine-related improvement in anxiety disorders emerges early, typically within the first few weeks of treatment. The magnitude and trajectory of this improvement are related to the dose and pharmacokinetic properties of the drug[5].

Lipophilicity and Potency

  • Lipophilicity of benzodiazepines is significantly associated with the response trajectory, with more lipophilic drugs producing smaller and slower improvements. However, potency, when corrected for dose, is not significantly associated with the response trajectory[5].

Challenges and Future Directions

Misuse, Dependence, and Side Effects

  • The market faces challenges related to the potential for misuse, dependence, and side effects associated with long-term use of benzodiazepine drugs. Regulatory bodies are increasingly focusing on ensuring the responsible use of these medications[3].

Shift Towards Personalized Medicine

  • There is a growing trend towards personalized medicine, with a focus on individualized treatment approaches and non-benzodiazepine alternatives. Digital health technologies are also being integrated to enhance the delivery and monitoring of benzodiazepine drugs[3].

Key Takeaways

  • The global benzodiazepine drugs market is expected to grow at a CAGR of 2.8% from 2022 to 2032.
  • North America is the dominant region, but the Asia Pacific is the fastest-growing market.
  • Alprazolam is the leading product, while clonazepam is the fastest-growing segment.
  • Hospital pharmacies are the primary distribution channel.
  • Regulatory concerns and alternative treatment options are key restraints.
  • The market is driven by growing mental health awareness and an aging population.

Frequently Asked Questions (FAQs)

1. What is the current market size of the global benzodiazepine drugs market?

The global benzodiazepine drugs market was valued at US$ 2.35 billion in 2022[1][3].

2. Which region is expected to be the fastest-growing in the benzodiazepine drugs market?

The Asia Pacific region is expected to be the fastest-growing, driven by increasing prevalence of anxiety disorders and improving healthcare infrastructure[1][3].

3. What is the dominant product in the benzodiazepine drugs market?

Alprazolam is the dominant product, holding approximately 29.6% of the market share in 2021[1][3].

4. What are the main drivers of the benzodiazepine drugs market?

The main drivers include growing awareness and diagnosis of mental health conditions, an aging population, and rising cases of sleep disorders[3].

5. What are the key restraints facing the benzodiazepine drugs market?

Regulatory concerns and guidelines, as well as the availability of alternative treatment options, are significant restraints[3].

Cited Sources:

  1. Fact.MR: Benzodiazepine Drugs Market Size, Share & Growth Trajectory 2032
  2. Colorado Department of Health Care Policy and Financing: DUR Board Minutes_February 2024
  3. SkyQuestT: Benzodiazepine Drugs Market Size And Share Report, 2031
  4. IQVIA Report: Stimulant Trends from 2012 - 2022
  5. Cambridge University Press: Pharmacologic predictors of benzodiazepine response trajectory in anxiety disorders: A Bayesian hierarchical modeling meta-analysis

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