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Last Updated: December 22, 2024

ACETAMINOPHEN; ASPIRIN; CODEINE PHOSPHATE - Generic Drug Details


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What are the generic sources for acetaminophen; aspirin; codeine phosphate and what is the scope of patent protection?

Acetaminophen; aspirin; codeine phosphate is the generic ingredient in four branded drugs marketed by Mikart and Scherer Labs, and is included in six NDAs. Additional information is available in the individual branded drug profile pages.

Summary for ACETAMINOPHEN; ASPIRIN; CODEINE PHOSPHATE
US Patents:0
Tradenames:4
Applicants:2
NDAs:6
DailyMed Link:ACETAMINOPHEN; ASPIRIN; CODEINE PHOSPHATE at DailyMed
Anatomical Therapeutic Chemical (ATC) Classes for ACETAMINOPHEN; ASPIRIN; CODEINE PHOSPHATE

US Patents and Regulatory Information for ACETAMINOPHEN; ASPIRIN; CODEINE PHOSPHATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Scherer Labs CODEINE, ASPIRIN, APAP FORMULA NO. 2 acetaminophen; aspirin; codeine phosphate CAPSULE;ORAL 085640-001 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Scherer Labs CODEINE, ASPIRIN, APAP FORMULA NO. 3 acetaminophen; aspirin; codeine phosphate CAPSULE;ORAL 085639-001 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Mikart ACETAMINOPHEN, ASPIRIN, AND CODEINE PHOSPHATE acetaminophen; aspirin; codeine phosphate CAPSULE;ORAL 081095-001 Oct 26, 1990 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Mikart ACETAMINOPHEN, ASPIRIN, AND CODEINE PHOSPHATE acetaminophen; aspirin; codeine phosphate CAPSULE;ORAL 081097-001 Oct 26, 1990 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Scherer Labs CODEINE, ASPIRIN, APAP FORMULA NO. 4 acetaminophen; aspirin; codeine phosphate CAPSULE;ORAL 085638-001 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

ACETAMINOPHEN; ASPIRIN; CODEINE PHOSPHATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Codeine Phosphate: A Comprehensive Analysis

Introduction

Codeine phosphate, a semi-synthetic opioid, is a crucial component in the pharmaceutical industry, particularly in pain management. This article delves into the market dynamics and financial trajectory of codeine phosphate, highlighting key drivers, trends, and future outlook.

Market Size and Growth

The codeine phosphate market was valued at USD 274.39 million in 2023 and is projected to reach USD 292.64 million in 2024, with a forecasted expansion to USD 489.81 million by 2032. This growth is driven by a Compound Annual Growth Rate (CAGR) of 6.65% during the forecast period of 2024-2032[1].

Drivers of Growth

Several factors are propelling the growth of the codeine phosphate market:

Rising Prevalence of Chronic Pain Conditions

The increasing incidence of chronic pain disorders such as arthritis, cancer-related pain, and postoperative pain management is a significant driver. As the global population ages, the demand for effective pain management solutions, including codeine phosphate, is on the rise[1].

Advancements in Drug Formulations

Advancements in drug delivery systems and formulation technologies have enhanced the efficacy and safety profiles of codeine phosphate. This makes it a preferred choice among healthcare professionals and patients, contributing to its market growth[1].

Expanding Healthcare Infrastructure

The expanding healthcare infrastructure in developing regions, particularly in Asia-Pacific, Latin America, and the Middle East, is opening new avenues for market growth. Increased healthcare investments and a rising middle-class population with better access to healthcare services are boosting the demand for pain management drugs like codeine phosphate[1].

Combination Therapies

The trend towards combination therapies, where codeine phosphate is paired with other analgesics like acetaminophen or aspirin, is gaining traction. These combinations enhance pain relief efficacy while minimizing the risk of side effects and dependency[1].

Market Trends

Shift Towards Combination Therapies

Combination therapies involving codeine phosphate and other analgesics are becoming more popular. For instance, the combination of acetaminophen and codeine phosphate has been shown to be statistically superior to codeine alone in terms of pain relief and reducing the need for remedication[3].

Increasing Healthcare Expenditure

Rising healthcare expenditure globally is another trend that supports the growth of the codeine phosphate market. As more resources are allocated to healthcare, the demand for effective pain management solutions increases[1].

Market Dynamics

Demand and Supply Factors

The demand for codeine phosphate is driven by the increasing prevalence of chronic pain conditions and the growing awareness about the benefits of opioid-based therapies. On the supply side, advancements in drug formulations and the expansion of pharmaceutical applications contribute to the market's growth[1].

Pricing Trends

Codeine phosphate products, such as CAPITALĀ® AND CODEINE ORAL SUSPENSION, are often at a significant price premium compared to their therapeutic alternatives. However, generic alternatives like acetaminophen and codeine oral solution are recommended when possible to manage costs[2].

Regulatory Influences

The codeine phosphate market is subject to regulatory frameworks, including the Opioid Analgesic REMS (Risk Evaluation and Mitigation Strategy) program. This program aims to prevent addiction, abuse, and misuse of opioid analgesics, which can impact market dynamics[5].

Financial Trajectory

Current Market Value

The current market value of codeine phosphate stands at USD 274.39 million as of 2023, with a projected increase to USD 292.64 million in 2024[1].

Future Projections

By 2032, the market is expected to expand to USD 489.81 million, driven by a CAGR of 6.65%. This growth is underpinned by the increasing demand for pain management solutions and the expanding healthcare infrastructure in developing regions[1].

Competitive Landscape

Key Players

The competitive landscape of the codeine phosphate market includes several key players who are investing in research and development to enhance drug formulations and delivery systems. These players are also focusing on combination therapies to offer more effective pain management solutions[1].

Regional Analysis

U.S. Market

In the U.S., the codeine phosphate market is driven by the rising prevalence of pain-related conditions and the increasing demand for effective pain management solutions. The expansion of pharmaceutical applications for codeine phosphate in combination pain relief medications is also a significant factor[1].

Global Markets

Globally, the market is witnessing significant growth in regions such as Asia-Pacific, Latin America, and the Middle East. These regions are experiencing a surge in healthcare investments, improving access to advanced medical treatments and pharmaceuticals[1].

Challenges and Opportunities

Dependency and Side Effects

One of the major challenges facing the codeine phosphate market is the risk of dependency and side effects associated with long-term use. However, combination therapies and advancements in drug formulations are helping to mitigate these risks[5].

Regulatory Compliance

Compliance with regulatory frameworks such as the Opioid Analgesic REMS program is crucial for market players. This compliance helps in preventing addiction, abuse, and misuse of opioid analgesics[5].

Key Takeaways

  • The codeine phosphate market is projected to grow significantly, driven by the rising prevalence of chronic pain conditions and advancements in drug formulations.
  • Combination therapies involving codeine phosphate and other analgesics are gaining traction.
  • Expanding healthcare infrastructure in developing regions is a key driver of market growth.
  • Regulatory compliance and managing the risks of dependency and side effects are critical for market players.

FAQs

Q: What are the primary uses of codeine phosphate?

A: Codeine phosphate is primarily used for its analgesic, antitussive, and antidiarrheal properties, particularly in pain management and cough suppression[4].

Q: How does the combination of acetaminophen and codeine phosphate compare to codeine alone?

A: The combination of acetaminophen and codeine phosphate has been shown to be statistically superior to codeine alone in terms of pain relief and reducing the need for remedication[3].

Q: What are the key drivers of the codeine phosphate market?

A: The key drivers include the rising prevalence of chronic pain conditions, advancements in drug formulations, increasing healthcare expenditures, and expanding healthcare infrastructure[1].

Q: What regulatory frameworks impact the codeine phosphate market?

A: The Opioid Analgesic REMS program is a significant regulatory framework that aims to prevent addiction, abuse, and misuse of opioid analgesics[5].

Q: What are the potential side effects of long-term codeine phosphate use?

A: Long-term use of codeine phosphate can lead to dependency, respiratory system depression, constipation, and other side effects. Gradual dose reduction can help prevent severe withdrawal side effects[5].

Sources

  1. Global Growth Insights - Codeine Phosphate Market Share, Forecast, 2032
  2. Minnesota Department of Human Services - Capital and Codeine / Minnesota Department of Human Services
  3. PubMed - Analysis of the analgesic efficacy of acetaminophen 1000 mg ...
  4. DrugBank Online - Codeine: Uses, Interactions, Mechanism of Action
  5. Mayo Clinic - Acetaminophen and codeine (oral route) - Mayo Clinic

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