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Last Updated: December 22, 2024

ACETAMINOPHEN; PROPOXYPHENE NAPSYLATE - Generic Drug Details


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What are the generic sources for acetaminophen; propoxyphene napsylate and what is the scope of patent protection?

Acetaminophen; propoxyphene napsylate is the generic ingredient in five branded drugs marketed by Xanodyne Pharm, Teva, Able, Actavis Elizabeth, Cornerstone, Halsey, Ivax Sub Teva Pharms, Mallinckrodt, Mirror Pharms, Mutual Pharm, Mylan, Mylan Pharms Inc, Sandoz, Superpharm, Vintage Pharms, Watson Labs, Watson Labs Florida, and Wockhardt Ltd, and is included in twenty-nine NDAs. Additional information is available in the individual branded drug profile pages.

Summary for ACETAMINOPHEN; PROPOXYPHENE NAPSYLATE
US Patents:0
Tradenames:5
Applicants:18
NDAs:29
DailyMed Link:ACETAMINOPHEN; PROPOXYPHENE NAPSYLATE at DailyMed

US Patents and Regulatory Information for ACETAMINOPHEN; PROPOXYPHENE NAPSYLATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mutual Pharm PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN acetaminophen; propoxyphene napsylate TABLET;ORAL 070116-001 Jun 12, 1985 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Mutual Pharm PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN acetaminophen; propoxyphene napsylate TABLET;ORAL 070115-001 Jun 12, 1985 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Teva PROPACET 100 acetaminophen; propoxyphene napsylate TABLET;ORAL 070107-001 Jun 12, 1985 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Sandoz PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN acetaminophen; propoxyphene napsylate TABLET;ORAL 070443-001 Jan 23, 1986 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Mirror Pharms PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN acetaminophen; propoxyphene napsylate TABLET;ORAL 077821-001 Feb 11, 2008 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Vintage Pharms PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN acetaminophen; propoxyphene napsylate TABLET;ORAL 074843-001 Feb 12, 1997 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Mutual Pharm PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN acetaminophen; propoxyphene napsylate TABLET;ORAL 070775-001 Mar 21, 1986 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; PROPOXYPHENE NAPSYLATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Acetaminophen and Propoxyphene Napsylate

Introduction

Acetaminophen and propoxyphene napsylate are two widely used pharmaceutical components, each with distinct market dynamics and financial trajectories. This article delves into the current market status, future projections, and key factors influencing the demand and supply of these drugs.

Acetaminophen Market Overview

Global Market Value 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%, reaching USD 15.2 billion by 2033[3].

Market Drivers

The demand for acetaminophen is driven by several factors:

  • Increasing Chronic Illnesses: The rise in chronic illnesses such as cancer and chronic obstructive pulmonary disease (COPD) has led to a higher demand for pain management medications, including acetaminophen[3].
  • Opioid Tolerance: The need for alternative pain management options due to opioid tolerance and the risks associated with opioid use has boosted the demand for acetaminophen[3].
  • Geriatric Population: The growing geriatric population, particularly in countries like China, where life expectancy has increased significantly, contributes to the increased demand for pain management drugs[3].

Regional Market Share

  • North America and Europe: These regions hold a significant market share due to the widespread availability and efficacy of acetaminophen, with a market share of approximately 62.1% in 2023[3].
  • Asia-Pacific: Countries like India and China dominate the Asia-Pacific market, driven by rapid economic growth and an increasing geriatric population. India holds about 45.5% of the South Asia market and is expected to show lucrative growth during the forecast period[3].

Propoxyphene Napsylate Market Dynamics

Historical Context

Propoxyphene, despite being a widely prescribed drug in the past (it was the 12th most prescribed generic drug in 2004 with over 23 million prescriptions), has faced significant regulatory scrutiny. It was placed in Schedule IV of the Controlled Substances Act due to its potential for dependence, although it is considered to have limited potential compared to Schedule II drugs like codeine[4].

Current Market Status

  • Generic Versions: Although the original manufacturer, Lilly, no longer produces propoxyphene-containing compounds, generic versions remain among the top-selling drugs. However, the market for propoxyphene napsylate has been impacted by concerns over its safety and efficacy[4].

Safety and Efficacy Concerns

  • Regulatory Actions: There have been petitions to ban propoxyphene products due to their associated risks, including respiratory depression, cardiac arrhythmias, and other serious side effects[4].
  • Clinical Studies: The efficacy of propoxyphene napsylate in combination with acetaminophen has been demonstrated in clinical studies for mild to severe postpartum pain, but there is insufficient information on its efficacy for chronic pain[1][2].

Financial Trajectory

Acetaminophen

  • Market Growth: The consistent growth in the acetaminophen market, driven by increasing demand for pain management and the expanding geriatric population, ensures a stable financial trajectory. The market is expected to expand significantly over the next decade, with a projected CAGR of 4.2% from 2023 to 2033[3].

Propoxyphene Napsylate

  • Declining Demand: The financial trajectory for propoxyphene napsylate is less optimistic due to the declining demand and regulatory challenges. The safety concerns and the availability of alternative pain management options have reduced its market share and financial viability[4].

Key Players and Market Competition

Acetaminophen

  • Major Players: The acetaminophen market is dominated by key players such as Pfizer Inc., Sanofi, Janssen Pharmaceuticals, Bayer AG, and GlaxoSmithKline plc. These companies benefit from the widespread use and acceptance of acetaminophen as a safe and effective pain reliever[3].

Propoxyphene Napsylate

  • Generic Market: The propoxyphene napsylate market is largely driven by generic versions, which are produced by various pharmaceutical companies. However, the market competition is reduced due to the declining demand and regulatory issues surrounding the drug[4].

Safety and Regulatory Considerations

Acetaminophen

  • Liver Dysfunction: Acetaminophen is associated with liver dysfunction, particularly in cases of overdose or chronic use. However, when used within recommended dosages, it is generally considered safe[2].
  • Renal Impairment: There is a risk of renal papillary necrosis with chronic acetaminophen use, especially when combined with other medications like aspirin[2].

Propoxyphene Napsylate

  • Respiratory Depression: Propoxyphene napsylate can cause severe respiratory depression, especially in elderly or debilitated patients. It also poses risks of hypotension and cardiac arrhythmias[1][2].
  • Geriatric Patients: The drug has a prolonged half-life in elderly patients, necessitating careful dosage adjustments to avoid adverse effects[1].

Clinical Usage and Efficacy

Acetaminophen

  • Pain Management: 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].

Propoxyphene Napsylate

  • Combination Therapy: Propoxyphene napsylate, when combined with acetaminophen, provides greater analgesia than either component alone. However, its use is limited by the potential for serious side effects and the availability of safer alternatives[1][2].

Conclusion

The market dynamics and financial trajectories of acetaminophen and propoxyphene napsylate are vastly different. Acetaminophen continues to grow in demand and market value, driven by its safety, efficacy, and the increasing need for pain management. In contrast, propoxyphene napsylate faces declining demand and financial viability due to safety concerns and regulatory challenges.

Key Takeaways

  • Acetaminophen: Expected to grow at a CAGR of 4.2% from 2023 to 2033, driven by increasing chronic illnesses and the need for safe pain management options.
  • Propoxyphene Napsylate: Faces declining demand due to safety concerns and regulatory issues, making its financial trajectory less promising.
  • Market Drivers: The geriatric population and the need for alternative pain management options are key drivers for acetaminophen, while regulatory challenges hinder the market for propoxyphene napsylate.
  • Safety Considerations: Both drugs have associated risks, but acetaminophen is generally considered safer when used within recommended dosages.

FAQs

Q1: What is the current market value of the global acetaminophen market?

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

Q2: What is the projected growth rate of the acetaminophen market from 2023 to 2033?

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

Q3: Why is the demand for acetaminophen increasing?

The demand is driven by the rise in chronic illnesses, the need for alternative pain management options due to opioid tolerance, and the growing geriatric population[3].

Q4: What are the safety concerns associated with propoxyphene napsylate?

Propoxyphene napsylate is associated with severe respiratory depression, hypotension, and cardiac arrhythmias, particularly in elderly or debilitated patients[1][2].

Q5: Why has the demand for propoxyphene napsylate declined?

The demand has declined due to safety concerns, regulatory challenges, and the availability of safer alternative pain management options[4].

Sources

  1. Drugs.com: Propoxyphene and Acetaminophen Tablets: Package Insert.
  2. Dailymed.nlm.nih.gov: Label: PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN tablet.
  3. Future Market Insights: Acetaminophen Market Size, Share, Trends & Outlook - 2033.
  4. Public Citizen: Petition to ban all Propoxyphene (Darvon) products.
  5. Dailymed.nlm.nih.gov: propoxyphene napsylate and acetaminophen tablet, film coated.

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