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Last Updated: December 22, 2024

ACETAMINOPHEN; PENTAZOCINE HYDROCHLORIDE - Generic Drug Details


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

Acetaminophen; pentazocine hydrochloride is the generic ingredient in two branded drugs marketed by Gavis Pharms, Watson Labs, and Sanofi Aventis Us, and is included in three NDAs. Additional information is available in the individual branded drug profile pages.

Summary for ACETAMINOPHEN; PENTAZOCINE HYDROCHLORIDE
US Patents:0
Tradenames:2
Applicants:3
NDAs:3
DailyMed Link:ACETAMINOPHEN; PENTAZOCINE HYDROCHLORIDE at DailyMed
Anatomical Therapeutic Chemical (ATC) Classes for ACETAMINOPHEN; PENTAZOCINE HYDROCHLORIDE

US Patents and Regulatory Information for ACETAMINOPHEN; PENTAZOCINE HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Gavis Pharms ACETAMINOPHEN AND PENTAZOCINE HYDROCHLORIDE acetaminophen; pentazocine hydrochloride TABLET;ORAL 076202-001 Aug 2, 2002 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Sanofi Aventis Us TALACEN acetaminophen; pentazocine hydrochloride TABLET;ORAL 018458-001 Sep 23, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Watson Labs ACETAMINOPHEN AND PENTAZOCINE HYDROCHLORIDE acetaminophen; pentazocine hydrochloride TABLET;ORAL 074699-001 Mar 24, 2000 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

ACETAMINOPHEN; PENTAZOCINE HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Acetaminophen and Pentazocine Hydrochloride

Introduction

Acetaminophen and pentazocine hydrochloride are components of a combination drug used for pain management, with each having distinct market dynamics and financial trajectories. Here, we will delve into the current market situation, future projections, and key factors influencing their market performance.

Market Overview of Acetaminophen

Global Market Size and Growth

The global acetaminophen market was valued at USD 9.8 billion in 2022 and is projected to grow at a Compound Annual Growth Rate (CAGR) of 4.2% to reach USD 15.2 billion by 2033[3].

Key Drivers of Demand

The demand for acetaminophen is driven by several factors:

  • Rising Chronic Illnesses: An increase in chronic illnesses such as cancer and chronic obstructive pulmonary disease (COPD) is a significant driver.
  • Pain Management: The need for effective pain management, particularly in cases where opioids are less effective or lead to tolerance and addiction, is another key factor.
  • Ease of Administration: The oral route of administration, which accounts for approximately 92.4% of the market share, is preferred due to its non-invasiveness, therapeutic response, and simplicity[3].

Regional Market Performance

  • North America and Europe: These regions hold a significant market share due to the widespread availability and efficacy of acetaminophen.
  • Asia-Pacific: Countries like India and China are experiencing rapid growth, driven by increasing life expectancy and the burden of non-communicable diseases. China is expected to grow at a CAGR of nearly 5.3% during the forecast period[3].

Market Dynamics of Pentazocine Hydrochloride

Combination Products

Pentazocine hydrochloride is often combined with acetaminophen in tablets, which are used for moderate to severe pain management. This combination is a Schedule IV controlled substance due to its potential for abuse[1][5].

Abuse and Reformulation

Historically, pentazocine hydrochloride, particularly in the form of Talwin 50, was abused when combined with tripelennamine (an antihistamine) to produce a heroin-like high. To combat this, the formulation was changed to include naloxone, which induces withdrawal-like symptoms if misused intravenously[4].

Clinical Use and Side Effects

Pentazocine hydrochloride is well absorbed from the gastrointestinal tract and has a mean plasma elimination half-life of 3.6 hours. However, it can cause a range of side effects including gastrointestinal issues, CNS effects like hallucinations and disorientation, and cardiovascular effects such as hypertension and hypotension[1][5].

Financial Trajectory

Revenue Projections

The financial trajectory of acetaminophen is robust, with the global market expected to expand significantly by 2033. The CAGR of 4.2% indicates steady growth driven by increasing demand for pain management solutions.

Key Market Players

Major pharmaceutical companies such as Pfizer Inc., Sanofi, Janssen Pharmaceuticals, Bayer AG, and GlaxoSmithKline plc are key players in the acetaminophen market. These companies contribute significantly to the revenue and market share of acetaminophen products[3].

Cost and Accessibility

The cost-effectiveness and ease of access to acetaminophen, particularly in over-the-counter (OTC) formulations, contribute to its widespread use and financial success. In regions like South Africa, Brazil, and Argentina, the affordability of OTC acetaminophen further drives market growth[3].

Market Challenges and Opportunities

Regulatory Environment

The regulatory environment, particularly around controlled substances like pentazocine hydrochloride, can impact market dynamics. Changes in regulations or formulations to prevent abuse can affect sales and market share.

Competitive Landscape

The acetaminophen market is highly competitive, with multiple players offering similar products. Differentiation through innovative formulations, branding, and marketing strategies is crucial for maintaining market share.

Emerging Markets

Emerging markets, especially in the Asia-Pacific region, offer significant opportunities for growth. Increasing healthcare expenditures and the rising prevalence of chronic diseases in these regions are driving the demand for pain management medications.

Geriatric Use and Future Trends

Geriatric Population

The geriatric population is a significant factor in the market for both acetaminophen and pentazocine hydrochloride. As life expectancy increases, particularly in countries like China, the demand for pain management solutions is expected to rise. Clinical studies, however, have not identified significant differences in responses between elderly and younger patients, though dose selection should be cautious due to potential decreased hepatic, renal, or cardiac function[1][5].

Future Trends

  • Opioid Tolerance: The market is shifting towards addressing opioid tolerance, with acetaminophen being a key component in managing pain without the risks associated with opioids.
  • Combination Therapies: Combination products like pentazocine hydrochloride and acetaminophen are expected to remain popular due to their balanced analgesic and antipyretic effects.

Key Takeaways

  • The global acetaminophen market is projected to grow at a CAGR of 4.2% to reach USD 15.2 billion by 2033.
  • Pentazocine hydrochloride, when combined with acetaminophen, is a Schedule IV controlled substance with specific market dynamics influenced by its potential for abuse.
  • Emerging markets, particularly in the Asia-Pacific region, are driving growth due to increasing healthcare expenditures and the prevalence of chronic diseases.
  • Regulatory changes and competitive strategies are crucial for maintaining market share in the highly competitive acetaminophen market.

FAQs

Q: What is the current market size of the global acetaminophen market?

A: The global acetaminophen market was valued at USD 9.8 billion in 2022[3].

Q: What is the projected CAGR for the global acetaminophen market from 2023 to 2033?

A: The global acetaminophen market is expected to grow at a CAGR of 4.2% from 2023 to 2033[3].

Q: Why is the demand for acetaminophen increasing?

A: The demand is driven by rising chronic illnesses, the need for effective pain management, and the ease of administration through oral routes[3].

Q: What are the key side effects of pentazocine hydrochloride?

A: Pentazocine hydrochloride can cause gastrointestinal issues, CNS effects like hallucinations and disorientation, and cardiovascular effects such as hypertension and hypotension[1][5].

Q: How has the formulation of pentazocine hydrochloride changed to combat abuse?

A: The formulation was changed to include naloxone, which induces withdrawal-like symptoms if misused intravenously[4].

Sources

  1. DailyMed: Pentazocine Hydrochloride and Acetaminophen Tablets.
  2. BU Articles: Making Buprenorphine Available without a Prescription.
  3. Future Market Insights: Acetaminophen Market Size, Share, Trends & Outlook - 2033.
  4. JAMA Network: Talwin 50 reformulated to avert 'T's and blues' abuse.
  5. DailyMed: Pentazocine Hydrochloride and Acetaminophen Tablet.

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