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Last Updated: December 27, 2024

PHERAZINE W/ CODEINE Drug Patent Profile


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When do Pherazine W/ Codeine patents expire, and when can generic versions of Pherazine W/ Codeine launch?

Pherazine W/ Codeine is a drug marketed by Halsey and is included in one NDA.

The generic ingredient in PHERAZINE W/ CODEINE is codeine phosphate; promethazine hydrochloride. There are nineteen drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the codeine phosphate; promethazine hydrochloride profile page.

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Summary for PHERAZINE W/ CODEINE
Drug patent expirations by year for PHERAZINE W/ CODEINE

US Patents and Regulatory Information for PHERAZINE W/ CODEINE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Halsey PHERAZINE W/ CODEINE codeine phosphate; promethazine hydrochloride SYRUP;ORAL 088739-001 Dec 23, 1988 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

PHERAZINE W/ CODEINE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for DXM and Codeine Syrup: A Comprehensive Analysis

Introduction

The market for DXM (Dextromethorphan) and codeine syrup is a complex and dynamic sector within the pharmaceutical industry. This article delves into the market dynamics, financial trajectory, and key factors influencing the growth and challenges of this market.

Market Drivers

Several factors are driving the growth of the DXM and codeine syrup market:

Increasing Incidence of Common Cold and Allergies

The rising incidence of common cold, allergies, and fever globally is a significant driver. As these conditions are prevalent, there is a higher demand for over-the-counter (OTC) cough and cold medications, which often include DXM and codeine syrups[1].

R&D Investments

Pharmaceutical companies are investing heavily in research and development to create various combination drug remedies for cough and cold symptoms. This innovation is expected to fuel market growth by offering more effective and diverse treatment options[1].

Aging Population and Chronic Pain

An aging population, particularly in regions like North America and Asia-Pacific, is experiencing higher rates of chronic pain. This demographic shift increases the demand for pain management solutions, including codeine formulations[4].

Market Restraints

Despite the growth drivers, there are several restraints affecting the market:

Drug Abuse and Misuse

The misuse of codeine-containing preparations, particularly the recreational use of "lean" or "purple drank," is a significant concern. This misuse can lead to severe health issues and has resulted in regulatory scrutiny and stricter controls[2][5].

Potential Side Effects

Codeine and DXM syrups can have side effects, which may deter some consumers and healthcare providers from recommending these medications. This caution can slow market growth[1].

Regulatory Limitations

The opioid crisis has led to stricter regulations on codeine and other opioid medications. Reclassification of codeine to prescription-only status in some regions, such as the proposed ban by Health Canada, is expected to hinder sales and adoption[4].

Market Segmentation

The DXM and codeine syrup market is segmented based on several criteria:

By Product

The market is segmented into DXM and promethazine-codeine cough syrup. These products cater to different therapeutic needs and consumer preferences[1].

By Application

The market is segmented into adult and children's applications, reflecting the diverse needs and dosages required for different age groups[1].

Regional Framework

The market is analyzed across five major regions: North America, Europe, Asia-Pacific (APAC), Middle East and Africa (MEA), and South & Central America.

North America

North America is expected to hold a dominant position in the global codeine market due to the high presence of key players and the approval and launch of novel products in the region[4].

Asia-Pacific

The APAC region is also significant, driven by an aging population and increasing healthcare expenditure. This region presents opportunities for market growth due to its large consumer base and growing demand for pain management solutions[4].

Financial Trajectory

Current Market Size

The codeine market was valued at USD 3.93 billion in 2023 and is expected to reach USD 4.11 billion in 2024. The DXM and codeine syrup market, while not separately valued, is part of this broader codeine market and is expected to contribute significantly to its growth[3].

Forecasted Growth

The codeine market is projected to grow at a CAGR of 4.65% to reach USD 5.40 billion by 2030. The DXM and codeine syrup segment is anticipated to witness high growth during this period, driven by increasing demand for cough and cold treatments and pain management solutions[3].

Competitive Landscape

Key players in the codeine market include:

  • Nexgen Pharma, Inc.
  • Teva Pharmaceutical Industries Ltd.
  • Wraser Pharmaceuticals LLC
  • Larken Laboratories, Inc.
  • Aurobindo Pharma Limited
  • Sun Pharmaceutical Industries Limited
  • Tris Pharma Inc.
  • Johnson & Johnson[4].

These companies are focusing on innovation, patient education, and adherence to regulatory changes to maintain and expand their market presence.

Opportunities and Future Trends

Safer Formulations

There is an emerging opportunity in developing safer, less addictive codeine formulations. This could involve technological advancements in pharmaceutical formulation design and exploring alternative natural sources for codeine derivatives[3].

Patient Education

Investing in patient education programs to enhance safe use awareness is crucial. This approach can help create a loyal consumer base while addressing societal concerns about drug misuse[3].

Regulatory Compliance

Market players must adhere to evolving legal landscapes and regulatory requirements. This includes complying with reclassification of codeine to prescription-only status in some regions and addressing potential misuse through education and monitoring[4].

Recreational Use and Misuse

The recreational use of codeine and DXM syrups, often mixed with soft drinks to create "lean" or "purple drank," remains a significant concern. This misuse has cultural prominence but poses serious health risks and regulatory challenges.

"Codeine is also available in conjunction with the anti-nausea medication promethazine in the form of a syrup. Brand named as Phenergan with Codeine or in generic form as promethazine with Codeine, it began to be mixed with soft drinks in the 1990s as a recreational drug, called 'syrup', 'lean', or 'purple drank'"[5].

Key Takeaways

  • The DXM and codeine syrup market is driven by increasing incidences of common cold, allergies, and chronic pain.
  • R&D investments and an aging population are significant growth factors.
  • Regulatory limitations and potential misuse are key restraints.
  • The market is segmented by product and application, with North America and APAC being key regions.
  • The financial trajectory indicates steady growth, with a projected CAGR of 4.65% for the broader codeine market.
  • Opportunities lie in developing safer formulations and patient education programs.

FAQs

What are the primary drivers of the DXM and codeine syrup market?

The primary drivers include increasing incidences of common cold and allergies, R&D investments by pharmaceutical companies, and an aging population with higher rates of chronic pain.

What are the main restraints affecting the DXM and codeine syrup market?

The main restraints include drug abuse and misuse, potential side effects, and regulatory limitations such as stricter controls on opioid medications.

Which regions are expected to dominate the DXM and codeine syrup market?

North America and Asia-Pacific are expected to hold significant market shares due to the presence of key players and growing demand for pain management solutions.

What are the opportunities for growth in the DXM and codeine syrup market?

Opportunities include developing safer, less addictive formulations, investing in patient education programs, and adhering to evolving regulatory requirements.

How is the recreational use of codeine and DXM syrups impacting the market?

The recreational use, particularly the creation of "lean" or "purple drank," poses significant health risks and regulatory challenges, affecting market growth and necessitating stricter controls and education programs.

Sources

  1. The Insight Partners, "DXM and Codeine Syrup Market Opportunities 2031".
  2. PLOS ONE, "Exploratory study on “lean” or “sizzurp” using national survey data".
  3. 360iResearch, "Codeine Market by Formulation (Capsule, Syrup, Tablet)".
  4. Coherent Market Insights, "Codeine Market - Companies, Size, Share & Research Analysis".
  5. Wikipedia, "Codeine".

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