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Last Updated: December 22, 2024

ACETAMINOPHEN, ASPIRIN, AND CODEINE PHOSPHATE Drug Patent Profile


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Which patents cover Acetaminophen, Aspirin, And Codeine Phosphate, and when can generic versions of Acetaminophen, Aspirin, And Codeine Phosphate launch?

Acetaminophen, Aspirin, And Codeine Phosphate is a drug marketed by Mikart and is included in three NDAs.

The generic ingredient in ACETAMINOPHEN, ASPIRIN, AND CODEINE PHOSPHATE is acetaminophen; aspirin; codeine phosphate. There are sixty-six drug master file entries for this compound. Additional details are available on the acetaminophen; aspirin; codeine phosphate profile page.

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Summary for ACETAMINOPHEN, ASPIRIN, AND CODEINE PHOSPHATE
US Patents:0
Applicants:1
NDAs:3
DailyMed Link:ACETAMINOPHEN, ASPIRIN, AND CODEINE PHOSPHATE at DailyMed
Drug patent expirations by year for ACETAMINOPHEN, ASPIRIN, AND CODEINE PHOSPHATE

US Patents and Regulatory Information for ACETAMINOPHEN, ASPIRIN, AND CODEINE PHOSPHATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
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 081096-001 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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

ACETAMINOPHEN, ASPIRIN, AND CODEINE PHOSPHATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Acetaminophen, Aspirin, and Codeine Phosphate

Introduction

The combination of acetaminophen, aspirin, and codeine phosphate is a potent analgesic formulation widely used for managing mild to moderate pain. This article delves into the market dynamics and financial trajectory of this drug combination, highlighting key drivers, trends, and future outlook.

Market Size and Growth

The market for codeine phosphate, a crucial component of this combination, was valued at USD 274.39 million in 2023 and is projected to reach USD 292.64 million in 2024. By 2032, it is expected to expand to USD 489.81 million, growing at a CAGR of 6.65% during the forecast period[1].

Drivers of Growth

Several factors drive the growth of the market for acetaminophen, aspirin, and codeine phosphate:

Rising Prevalence of Chronic Pain

The increasing incidence of chronic pain conditions such as arthritis, cancer-related pain, and postoperative pain management significantly boosts the demand for effective analgesic solutions. Codeine phosphate, with its potent analgesic properties, is a critical component in these regimens[1].

Advancements in Drug Formulations

Improvements in drug delivery systems and formulation technologies have enhanced the efficacy and safety profiles of these medications. Combination therapies, where codeine phosphate is paired with acetaminophen or aspirin, offer a balanced solution for pain management, reducing the risk of side effects and dependency[1].

Expanding Healthcare Infrastructure

The growing 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 driving the demand for pain management drugs[1].

Market Trends

Combination Therapies

One of the notable trends is the shift towards combination therapies. Pairing codeine phosphate with other analgesics like acetaminophen or aspirin enhances pain relief efficacy while allowing for lower doses of each active ingredient. This approach is gaining traction as it offers a balanced solution for both acute and chronic pain sufferers[1].

Oral Route of Administration

The oral route of administration remains dominant, particularly for acetaminophen, which claims a significant share of the market. This preference underscores the efficacy and convenience of oral consumption, shaping the landscape for analgesic utilization[3].

Financial Trajectory

Codeine Phosphate Market

The codeine phosphate market is expected to grow from USD 274.39 million in 2023 to USD 489.81 million by 2032, with a CAGR of 6.65%. This growth is driven by the increasing demand for effective pain management solutions and the expansion of pharmaceutical applications for codeine phosphate[1].

Acetaminophen Market

The global acetaminophen market, which is closely related to the combination therapies involving codeine phosphate, was valued at USD 9.8 billion in 2022. It is anticipated to reach USD 15.2 billion by 2033, growing at a CAGR of 4.2%. This robust growth underscores the significance of acetaminophen in pain management and fever relief[3].

Regulatory Influences

Opioid Analgesic REMS Program

The use of codeine phosphate is regulated under the Opioid Analgesic REMS (Risk Evaluation and Mitigation Strategy) program. This program aims to prevent addiction, abuse, and misuse of opioid-based medications. Compliance with this program is crucial for the safe and effective use of codeine phosphate combination products[4].

Competitive Landscape

The market for acetaminophen, aspirin, and codeine phosphate is competitive, with various pharmaceutical companies offering different formulations. The preference for generic alternatives, such as generic acetaminophen and codeine oral solution, over branded products like CAPITALĀ® AND CODEINE ORAL SUSPENSION, also influences market dynamics[2].

Safety and Efficacy Considerations

Side Effects and Dependency

Codeine phosphate can become habit-forming when used for a long time, leading to mental or physical dependence. However, when used as directed for pain management, the risk of addiction is minimized. Acetaminophen, while generally safe, can cause serious liver damage if taken in large doses[4].

Pediatric and Geriatric Use

The use of acetaminophen and codeine combination in children under 12 years is not recommended due to safety and efficacy concerns. In elderly patients, caution is advised due to potential age-related health issues such as liver, kidney, heart, or lung problems[4].

Future Outlook

The market for acetaminophen, aspirin, and codeine phosphate is poised for significant growth driven by increasing healthcare needs, advancements in drug formulations, and expanding healthcare infrastructure. As the global population ages and chronic pain conditions rise, the demand for effective pain management solutions is expected to continue.

"The acetaminophen market is not merely a financial figure; it represents a crucial player in addressing global healthcare challenges. As it forges ahead towards a projected valuation of US$ 15.2 billion by 2033, it positions itself as a cornerstone in pain management and fever relief, catering to diverse medical needs."[3]

Key Takeaways

  • The codeine phosphate market is projected to grow from USD 274.39 million in 2023 to USD 489.81 million by 2032.
  • Combination therapies with acetaminophen or aspirin are gaining traction due to enhanced efficacy and reduced risk of side effects.
  • The acetaminophen market is expected to reach USD 15.2 billion by 2033, driven by its role in pain management and fever relief.
  • Regulatory compliance, particularly with the Opioid Analgesic REMS program, is crucial for the safe use of codeine phosphate.
  • Safety and efficacy considerations, especially in pediatric and geriatric populations, are important for the effective use of these medications.

Frequently Asked Questions (FAQs)

1. What are the primary uses of acetaminophen, aspirin, and codeine phosphate combination?

The combination is primarily used for the relief of mild to moderate pain and can also be used for reducing fever.

2. What are the key drivers of the codeine phosphate market growth?

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

3. What are the risks associated with long-term use of codeine phosphate?

Long-term use of codeine phosphate can lead to mental or physical dependence. However, when used as directed for pain management, the risk of addiction is minimized.

4. Why is the oral route of administration preferred for acetaminophen?

The oral route of administration is preferred due to its efficacy and convenience, with oral consumption claiming a dominant share of the market.

5. What regulatory program governs the use of codeine phosphate?

The use of codeine phosphate is regulated under the Opioid Analgesic REMS (Risk Evaluation and Mitigation Strategy) program to prevent addiction, abuse, and misuse.

Cited 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. PharmiWeb - Acetaminophen Market Skyrockets to a Whopping US$ 15.2 Billion Valuation by 2033
  4. Mayo Clinic - Acetaminophen and codeine (oral route) - Mayo Clinic

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