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Last Updated: December 22, 2024

Pentazocine hydrochloride - Generic Drug Details


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What are the generic sources for pentazocine hydrochloride and what is the scope of patent protection?

Pentazocine hydrochloride is the generic ingredient in one branded drug marketed by Sanofi Aventis Us and is included in one NDA. Additional information is available in the individual branded drug profile pages.

There are three drug master file entries for pentazocine hydrochloride.

Summary for pentazocine hydrochloride
Recent Clinical Trials for pentazocine hydrochloride

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

SponsorPhase
Federal Medical Centre, YenagoaN/A
Olakunle Ifeoluwa MakindeN/A
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityN/A

See all pentazocine hydrochloride clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for pentazocine hydrochloride

US Patents and Regulatory Information for pentazocine hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sanofi Aventis Us TALWIN 50 pentazocine hydrochloride TABLET;ORAL 016732-001 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

Pentazocine hydrochloride Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Pentazocine Hydrochloride

Introduction

Pentazocine hydrochloride, a potent opioid analgesic with agonist/antagonist properties, is used to manage moderate to severe pain. Understanding its market dynamics and financial trajectory is crucial for stakeholders, including pharmaceutical companies, investors, and healthcare providers.

Market Size and Growth

The global pentazocine HCl market is projected to experience significant growth over the forecast period from 2025 to 2031. The market size is estimated based on historical data from 2019 to 2023 and forecasted data up to 2031. This growth is driven by increasing demand for effective pain management solutions, particularly in regions with aging populations and rising incidences of chronic pain conditions[1][4].

CAGR and Revenue Share

The pentazocine HCl market is expected to register a notable Compound Annual Growth Rate (CAGR) by 2031. This growth rate is influenced by factors such as the expanding geriatric population, advancements in healthcare infrastructure, and the increasing prevalence of pain-related disorders. The revenue share of pentazocine HCl is anticipated to rise, making it a significant player in the opioid analgesics market[1][4].

Segment Analysis

By Type

The market can be segmented by type, with oral formulations being the dominant segment. Pentazocine hydrochloride tablets, often combined with naloxone to deter misuse, account for the largest share of the global market. This is due to their ease of administration and the balanced analgesic and antagonist effects they provide[2][5].

By Application

Pentazocine HCl is used in various medical applications, including post-operative pain, chronic pain management, and palliative care. The chronic pain management segment is expected to drive significant growth due to the increasing prevalence of conditions such as arthritis and cancer.

By Region

Geographically, the market is segmented into regions such as North America, Europe, Asia-Pacific, and others. North America is expected to dominate the market during the forecast period, driven by advanced healthcare infrastructure and high demand for pain management solutions. However, the Asia-Pacific region is anticipated to show rapid growth due to its large population and increasing healthcare expenditure[1][4].

Key Drivers and Opportunities

Increasing Demand for Pain Management

The rising incidence of chronic pain conditions and the need for effective pain management solutions are key drivers of the pentazocine HCl market. The aging population and growing awareness about pain management further fuel this demand.

Advancements in Healthcare

Improvements in healthcare infrastructure and the adoption of advanced medical technologies in emerging markets present significant opportunities for the growth of the pentazocine HCl market.

Regulatory Support

Governments and regulatory bodies are focusing on ensuring adequate access to opioid analgesics for medical purposes while mitigating the risks of misuse. This balanced approach supports the legitimate use of pentazocine HCl, driving market growth[3].

Restraints and Challenges

Misuse and Dependence

Pentazocine HCl, being a Schedule IV controlled substance, faces challenges related to misuse and dependence. The inclusion of naloxone in some formulations aims to curb parenteral misuse, but oral misuse remains a concern[2][5].

Side Effects and Safety Concerns

The drug has several side effects, including respiratory depression, sedation, and potential for liver impairment, especially when combined with other substances. These safety concerns can limit its adoption in certain patient populations[5].

Global Pain Divide

The imbalance in the availability of opioid analgesics, particularly in low- and middle-income countries, is a significant challenge. Addressing this "global pain divide" is crucial for ensuring equitable access to pain management solutions[3].

Competitor Analysis

The pentazocine HCl market is competitive, with several pharmaceutical companies involved in its production and distribution. Key players focus on differentiating their products through formulation improvements, such as the combination with naloxone, and enhancing their distribution networks to reach a broader market[1].

ESG and PESTEL Analysis

Environmental, Social, and Governance (ESG) Factors

The production and distribution of pentazocine HCl must comply with environmental regulations, ensure social responsibility in terms of access and misuse prevention, and adhere to governance standards related to pharmaceutical manufacturing and distribution.

Political, Economic, Social, Technological, Environmental, and Legal (PESTEL) Factors

Political factors include regulatory policies and international control measures. Economic factors involve healthcare expenditure and reimbursement policies. Social factors include the prevalence of pain conditions and public awareness. Technological advancements in drug delivery systems and environmental considerations related to pharmaceutical waste are also important. Legal factors encompass controlled substance regulations and patent laws[1].

Technological Trends

Advancements in drug delivery systems, such as sustained-release formulations and combination therapies, are expected to influence the market. Additionally, technological improvements in manufacturing processes can enhance the efficiency and cost-effectiveness of pentazocine HCl production[1].

SWOT Analysis

Strengths

  • Effective pain management
  • Balanced agonist/antagonist action
  • Wide range of applications

Weaknesses

  • Potential for misuse and dependence
  • Side effects and safety concerns
  • Limited availability in some regions

Opportunities

  • Growing demand for pain management
  • Advancements in healthcare infrastructure
  • Regulatory support

Threats

  • Competition from other analgesics
  • Regulatory challenges
  • Global health crises affecting supply chains

COVID-19 Impact

The COVID-19 pandemic has had a mixed impact on the pentazocine HCl market. On one hand, it has highlighted the need for effective pain management solutions, particularly in patients with COVID-19 who may experience severe pain. On the other hand, supply chain disruptions and economic instability have posed challenges to the market[1].

Consumer Behavior Analysis

Consumer behavior plays a crucial role in the pentazocine HCl market. Patients' preferences for effective and safe pain management solutions, along with healthcare providers' prescribing habits, influence market dynamics. Increasing awareness about the risks and benefits of opioid analgesics also shapes consumer behavior[1].

Key Takeaways

  • The pentazocine HCl market is expected to grow significantly due to increasing demand for pain management solutions.
  • The market is driven by factors such as the aging population, advancements in healthcare, and regulatory support.
  • Challenges include misuse and dependence, side effects, and the global pain divide.
  • Technological advancements and ESG considerations are crucial for market growth.
  • Consumer behavior and healthcare provider preferences are key influencers of market dynamics.

FAQs

1. What is the primary use of pentazocine hydrochloride?

Pentazocine hydrochloride is primarily used for the management of moderate to severe pain, including post-operative pain and chronic pain conditions.

2. What are the key drivers of the pentazocine HCl market?

The key drivers include increasing demand for pain management solutions, advancements in healthcare infrastructure, and regulatory support to ensure adequate access to opioid analgesics.

3. What are the major side effects of pentazocine hydrochloride?

Major side effects include respiratory depression, sedation, potential for liver impairment, and other systemic effects such as headache, chills, and urinary retention.

4. How does the inclusion of naloxone in pentazocine HCl formulations impact the market?

The inclusion of naloxone is intended to curb parenteral misuse by providing an antagonist effect when the drug is injected, thereby reducing the potential for abuse.

5. What are the regional dynamics of the pentazocine HCl market?

North America is expected to dominate the market, while the Asia-Pacific region is anticipated to show rapid growth due to its large population and increasing healthcare expenditure.

Cited Sources:

  1. Global Pentazocine HCl Market Report 2024 Edition - Cognitivemarketresearch.com
  2. Pentazocine hydrochloride and naloxone hydrochloride tablet - Dailymed.nlm.nih.gov
  3. INTERNATIONAL NARCOTICS CONTROL BOARD - Incb.org
  4. Pentazocine Hcl Market Key Findings by 2031 - Theinsightpartners.com
  5. Pentazocine hydrochloride, USP - Accessdata.fda.gov

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