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Last Updated: December 22, 2024

ACETAMINOPHEN AND PENTAZOCINE HYDROCHLORIDE Drug Patent Profile


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Which patents cover Acetaminophen And Pentazocine Hydrochloride, and what generic alternatives are available?

Acetaminophen And Pentazocine Hydrochloride is a drug marketed by Gavis Pharms and Watson Labs and is included in two NDAs.

The generic ingredient in ACETAMINOPHEN AND PENTAZOCINE HYDROCHLORIDE is acetaminophen; pentazocine hydrochloride. There are sixty-six drug master file entries for this compound. Additional details are available on the acetaminophen; pentazocine hydrochloride profile page.

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Summary for ACETAMINOPHEN AND PENTAZOCINE HYDROCHLORIDE
US Patents:0
Applicants:2
NDAs:2
DailyMed Link:ACETAMINOPHEN AND PENTAZOCINE HYDROCHLORIDE at DailyMed
Drug patent expirations by year for ACETAMINOPHEN AND PENTAZOCINE HYDROCHLORIDE

US Patents and Regulatory Information for ACETAMINOPHEN AND 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
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 AND PENTAZOCINE HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Acetaminophen and Pentazocine Hydrochloride

Introduction

Acetaminophen and pentazocine hydrochloride are widely used medications, each with distinct market dynamics and financial trajectories. This article will delve into the current market situation, future projections, and key factors influencing the demand and financial performance of these drugs.

Acetaminophen Market Overview

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].

Market Share and Distribution

The oral route of administration dominates the acetaminophen market, accounting for approximately 92.4% of the market share in 2022. This trend is expected to continue, driven by the non-invasive, practical, and economical nature of oral medication delivery[3].

Key Drivers of Demand

The demand for acetaminophen is driven by several factors:

  • Chronic Illnesses: An increase in chronic illnesses such as cancer and chronic obstructive pulmonary disease (COPD) contributes significantly to the demand.
  • Opioid Tolerance: The need for alternative pain management options due to opioid tolerance and the risks associated with opioid use.
  • Post-Operative Pain Management: Acetaminophen is often used in post-operative pain management, further boosting its demand[3].

Regional Market Dynamics

  • 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 driving growth, with India holding approximately 45.5% of the South Asia market in 2022. China's growing geriatric population and increasing life expectancy are key factors[3].

Pentazocine Hydrochloride Market Dynamics

Combination Products

Pentazocine hydrochloride is often combined with acetaminophen, forming a Schedule IV controlled substance. This combination is used for moderate to severe pain management[2].

Market Size and Growth

While specific financial data for pentazocine hydrochloride alone is not readily available, its market dynamics are closely tied to the broader opioid analgesic market. The introduction of new opioid products, including combinations like pentazocine and acetaminophen, has a complex impact on the market.

Prescription Trends

Historically, the introduction of new opioid products has not significantly increased overall prescribing rates. For example, tapentadol, a new molecular entity approved during the 2008-2015 period, accounted for only 0.3% of the total opioid analgesic market in 2015[1].

Financial Trajectory

Acetaminophen

  • Revenue Projections: The acetaminophen market is expected to grow steadily, driven by increasing demand for pain management solutions. The projected growth to USD 15.2 billion by 2033 indicates a robust financial trajectory.
  • Key Players: Major pharmaceutical companies such as Pfizer, Sanofi, and GlaxoSmithKline are key players in the acetaminophen market, contributing to its financial stability and growth[3].

Pentazocine Hydrochloride

  • Revenue Impact: The financial performance of pentazocine hydrochloride is influenced by its use in combination products and its classification as a controlled substance. While it does not dominate the opioid market, it remains a viable option for pain management.
  • Market Share: The combined market share of newly approved brand products, including those containing pentazocine, accounted for only a small percentage of the total opioid analgesic market in 2015. However, this does not diminish its importance in specific clinical scenarios[1].

Challenges and Opportunities

Regulatory Environment

The regulatory environment, particularly around opioid use, can significantly impact the market dynamics of both acetaminophen and pentazocine hydrochloride. Stricter regulations on opioid prescriptions can drive demand for alternative pain management options like acetaminophen[3].

Competition from Generics

The introduction of generic versions of opioid analgesics can affect the market share of brand products, including those containing pentazocine. However, generics also increase patient accessibility and utilization, which can benefit the overall market[1].

Clinical and Therapeutic Use

Acetaminophen

  • Therapeutic Use: Acetaminophen is widely used for its analgesic and antipyretic properties. It is often combined with opioids to enhance pain management without increasing side effects[3].
  • Safety Profile: Acetaminophen is generally safe when used at recommended doses, making it a preferred option for long-term pain management.

Pentazocine Hydrochloride

  • Therapeutic Use: Pentazocine hydrochloride is used for moderate to severe pain management. Its combination with acetaminophen provides a balanced analgesic effect.
  • Safety Profile: While pentazocine has a range of potential side effects, including gastrointestinal and CNS effects, its controlled use under medical supervision minimizes risks[2].

Market Outlook

Growth Drivers

  • Increasing Chronic Illnesses: The rising prevalence of chronic diseases will continue to drive demand for both acetaminophen and pentazocine hydrochloride.
  • Aging Population: The growing geriatric population, especially in regions like China, will increase the need for pain management solutions.

Challenges

  • Regulatory Scrutiny: Ongoing regulatory scrutiny of opioid products may impact the market dynamics of pentazocine hydrochloride.
  • Generic Competition: The increasing availability of generic opioids could affect the market share of brand products.

Key Takeaways

  • The acetaminophen market is poised for significant growth, driven by increasing demand for pain management solutions and the need for alternatives to opioids.
  • Pentazocine hydrochloride, while not a dominant player in the opioid market, remains a crucial option for specific pain management needs.
  • Regulatory and competitive factors will continue to shape the market dynamics of both drugs.

Frequently Asked Questions (FAQs)

Q: What is the projected growth rate of the global acetaminophen market? A: The global acetaminophen market is expected to grow at a CAGR of 4.2% from 2022 to 2033[3].

Q: Which route of administration dominates the acetaminophen market? A: The oral route of administration accounts for approximately 92.4% of the acetaminophen market share[3].

Q: What are the key drivers of demand for acetaminophen? A: The demand is driven by chronic illnesses, opioid tolerance, and post-operative pain management needs[3].

Q: How does the combination of pentazocine hydrochloride and acetaminophen impact the market? A: This combination is used for moderate to severe pain management and is classified as a Schedule IV controlled substance, influencing its market dynamics[2].

Q: What are the potential challenges for pentazocine hydrochloride in the market? A: Regulatory scrutiny of opioid products and competition from generics are significant challenges[1][2].

Cited Sources:

  1. Chai et al. - "New Opioid Analgesic Approvals and Outpatient Utilization of Opioid Analgesics in the United States, 1997-2015." Anesthesiology, vol. 128, no. 5, 2018, pp. 953-966.
  2. DailyMed - "Pentazocine Hydrochloride and Acetaminophen Tablet."
  3. Future Market Insights - "Acetaminophen Market Size, Share, Trends & Outlook - 2033."

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