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Last Updated: December 22, 2024

PROMETHAZINE WITH CODEINE Drug Patent Profile


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When do Promethazine With Codeine patents expire, and when can generic versions of Promethazine With Codeine launch?

Promethazine With Codeine is a drug marketed by Pharm Assoc and is included in one NDA.

The generic ingredient in PROMETHAZINE WITH 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 PROMETHAZINE WITH CODEINE
Drug patent expirations by year for PROMETHAZINE WITH CODEINE
Pharmacology for PROMETHAZINE WITH CODEINE
Drug ClassOpioid Agonist
Phenothiazine
Mechanism of ActionFull Opioid Agonists

US Patents and Regulatory Information for PROMETHAZINE WITH CODEINE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pharm Assoc PROMETHAZINE WITH CODEINE codeine phosphate; promethazine hydrochloride SYRUP;ORAL 040650-001 Jan 31, 2006 AA RX 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

PROMETHAZINE WITH CODEINE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Promethazine with Codeine

Market Overview

The market for Promethazine with Codeine, a combination drug used for the temporary relief of cough and upper respiratory symptoms, is part of the broader DXM and Codeine Syrup market. This market is characterized by several key dynamics that influence its growth and financial trajectory.

Market Drivers

Increasing Incidences of Common Cold and Allergies

The global market for Promethazine with Codeine is driven by the increasing incidences of common cold, allergies, and fever. As these conditions are prevalent and often treated with over-the-counter (OTC) medications, the demand for cough and cold remedies, including those containing Promethazine and Codeine, is on the rise[1].

Rising Awareness and Self-Medication

There is a growing trend of self-medication, with many people opting to treat common cold and cough symptoms on their own. This trend, coupled with the availability of OTC cough preparations, contributes significantly to the market growth[1].

R&D Investments

Pharmaceutical companies are investing heavily in research and development to create various combination drug remedies for cough and cold. These investments are expected to fuel market growth by introducing new and effective products[1].

Market Restraints

Drug Abuse and Misuse

One of the significant restraints on the market is the potential for drug abuse and misuse, particularly with codeine-containing preparations. Codeine has a high dependence and addiction liability, which can lead to regulatory scrutiny and public health concerns[2][4].

Side Effects and Safety Concerns

The combination of Promethazine and Codeine can have serious side effects, including life-threatening respiratory depression, especially in children. These safety concerns can limit the use of these medications and impact market growth[4].

Market Segmentation

By Product

The market is segmented into different products, including DXM and Promethazine-codeine cough syrup. Promethazine with Codeine is a specific product within this segment, indicated for the temporary relief of cough and upper respiratory symptoms[1].

By Application

The market is also segmented by application, with Promethazine with Codeine primarily used for adults. The use of this medication in pediatric patients is contraindicated due to the risks of respiratory depression and other adverse effects[4].

Regional Framework

Global Market

The market for Promethazine with Codeine is analyzed across five major regions: North America, Europe, Asia-Pacific (APAC), Middle East and Africa (MEA), and South & Central America. Each region has its own market size and forecast estimates from 2021 to 2031[1].

Country-Level Analysis

The report provides a detailed analysis of 18 countries globally, including current trends and opportunities prevailing in each region. This granular analysis helps in understanding the regional dynamics and potential growth areas[1].

Financial Trajectory

Market Size and Growth

The DXM and Codeine Syrup market, which includes Promethazine with Codeine, is expected to witness high growth during the forecast period from 2023 to 2031, with a significant CAGR. The market size is projected to increase from US$ XX million in 2023 to US$ XX million by 2031[1].

Revenue Forecast

Historical data from 2021 to 2022 and forecast data from 2024 to 2031 provide a comprehensive view of the market's financial trajectory. The revenue forecast includes company analysis, industry landscape, growth factors, and trends[1].

Key Players and Market Strategies

Company Profiles

Major pharmaceutical companies, such as Akorn, Inc., are key players in the market. These companies focus on organic growth strategies like product launches and approvals, as well as inorganic strategies like acquisitions and partnerships[1][3].

Product Launches and Approvals

For instance, Akorn launched additional Promethazine syrup formulations, including Promethazine/Phenylephrine/Codeine Syrup, which complements their existing product line. Such launches are crucial for expanding the business and customer base[3].

Challenges and Opportunities

Regulatory Environment

The market is influenced by regulatory factors, including the approval of new drug applications and the monitoring of drug safety. For example, the FDA approval of abbreviated new drug applications (ANDAs) for Promethazine/Phenylephrine/Codeine Syrup is a significant regulatory milestone[3].

Cultural and Social Factors

The cultural prominence of "lean" or "purple drank," a concoction that includes Promethazine and Codeine, has both positive and negative impacts. While it increases awareness, it also highlights the risks of misuse and addiction[5].

PEST Analysis

Political Factors

Political factors, such as regulatory policies and healthcare reforms, affect the market. For example, stricter regulations on opioid use can impact the sales of codeine-containing products[1].

Economic Factors

Economic factors, including the cost of raw materials and manufacturing, influence the pricing and profitability of these medications. Economic downturns can also affect consumer spending on healthcare products[1].

Social Factors

Social factors, such as public health campaigns and awareness about drug abuse, play a crucial role in shaping market dynamics. Increasing awareness about the risks associated with codeine can lead to reduced demand[1].

Technological Factors

Technological advancements in drug development and manufacturing processes can improve the efficacy and safety of Promethazine with Codeine, potentially driving market growth[1].

Key Takeaways

  • The market for Promethazine with Codeine is driven by increasing incidences of common cold and allergies, as well as rising awareness and self-medication trends.
  • Regulatory and safety concerns, particularly related to codeine abuse and side effects, are significant restraints.
  • The market is segmented by product and application, with a focus on adult use due to safety concerns in pediatric patients.
  • Regional analysis highlights growth opportunities across different geographies.
  • Key players are focusing on both organic and inorganic growth strategies to expand their market share.

Frequently Asked Questions (FAQs)

1. What are the primary uses of Promethazine with Codeine?

Promethazine with Codeine is used for the temporary relief of cough and upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold in adults[4].

2. What are the major side effects of Promethazine with Codeine?

Major side effects include life-threatening respiratory depression, especially in children, as well as other adverse effects like vomiting, constipation, itchiness, lightheadedness, and drowsiness[2][4].

3. Why is the use of Promethazine with Codeine contraindicated in children?

The use is contraindicated in children due to the high risk of respiratory depression and other serious side effects. Children may be ultra-rapid metabolizers of codeine, increasing these risks[4].

4. How does the cultural prominence of "lean" impact the market?

The cultural prominence of "lean" or "purple drank" increases awareness but also highlights the risks of misuse and addiction, which can negatively impact the market by leading to regulatory scrutiny and public health concerns[5].

5. What are the key growth strategies employed by market players?

Market players employ both organic growth strategies such as product launches and approvals, and inorganic strategies like acquisitions and partnerships to expand their business and customer base[1][3].

Cited Sources:

  1. The Insight Partners. DXM and Codeine Syrup Market Opportunities 2031.
  2. Wikipedia. Codeine.
  3. GlobeNewswire. Akorn Launches Two Additional Promethazine Syrup Formulations.
  4. Drugs.com. Promethazine VC with Codeine: Package Insert / Prescribing Info.
  5. PLOS ONE. Exploratory study on “lean” or “sizzurp” using national survey data.

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