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Last Updated: February 12, 2025

Drug Price Trends for PROMETHAZINE-CODEINE SOLUTION


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Drug Price Trends for PROMETHAZINE-CODEINE SOLUTION

Average Pharmacy Cost for PROMETHAZINE-CODEINE SOLUTION

These are average pharmacy acquisition costs (net of discounts) from a US national survey
Drug Name NDC Price/Unit ($) Unit Date
PROMETHAZINE-CODEINE SOLUTION 70752-0139-12 0.03952 ML 2025-01-22
PROMETHAZINE-CODEINE SOLUTION 27808-0065-02 0.03952 ML 2025-01-22
PROMETHAZINE-CODEINE SOLUTION 70752-0139-12 0.04052 ML 2024-12-18
>Drug Name >NDC >Price/Unit ($) >Unit >Date

Market Analysis and Price Projections for Promethazine-Codeine Solution

Market Overview

The Promethazine-Codeine solution market is a segment of the broader pharmaceutical industry, specifically focusing on cough and cold remedies. This market is driven by several key factors, including the increasing incidence of common colds, allergies, and fever globally, as well as rising awareness among people to treat these symptoms effectively[1].

Market Dynamics

Drivers

  • The global market for Promethazine-Codeine solutions is fueled by the high prevalence of respiratory symptoms such as coughs and nasal congestion associated with allergies and the common cold.
  • Increasing R&D investments by pharmaceutical companies to develop combination drug remedies for cough and cold symptoms also contribute to market growth.
  • The availability of these products over-the-counter (OTC) in many regions further boosts demand[1].

Restraints

  • One of the significant restraints is the potential for drug abuse and misuse, particularly with codeine-containing preparations. This has led to stringent regulations and monitoring.
  • The risk of serious side effects, such as life-threatening respiratory depression, especially in pediatric patients, is another major concern[4].

Market Segmentation

The Promethazine-Codeine solution market is segmented based on product and application.

Product Segmentation

  • The market includes products such as Promethazine HCl and Codeine Phosphate Syrup, and Promethazine HCl, Phenylephrine HCl, and Codeine Phosphate Syrup. These products are often marketed under different brand names and generic labels[2].

Application Segmentation

  • The primary applications are for adults and children, although the use in pediatric patients is strictly regulated due to safety concerns. For instance, Promethazine VC with Codeine is contraindicated in children under 12 years of age and in adolescents 12 to 18 years of age following tonsillectomy or adenoidectomy[4].

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

  • This region is a significant market due to the high prevalence of respiratory conditions and the presence of major pharmaceutical companies. For example, Akorn, Inc. has launched several Promethazine and Codeine syrup formulations in the U.S. market[2].

Europe and APAC

  • These regions also show substantial growth due to increasing healthcare expenditure and a large patient population. The market in these regions is further segmented by country, providing detailed insights into local market trends and opportunities[1].

Market Size and Growth Projections

The global Promethazine-Codeine solution market is expected to witness high growth during the forecast period from 2023 to 2031, with a projected Compound Annual Growth Rate (CAGR) of XX%[1].

Historical Data and Forecast

  • The market size in 2023 is estimated to be US$ XX Million, with projections indicating it will reach US$ XX Million by 2031.
  • Historical data from 2021-2022 and forecast data from 2024-2031 provide a comprehensive view of market trends and future outlook[1].

Key Players and Competitive Landscape

The market is competitive, with several key players operating globally.

Akorn, Inc.

  • Akorn, Inc. is a notable player, having launched multiple Promethazine and Codeine syrup formulations. Their products include Promethazine HCl and Codeine Phosphate Syrup, and Promethazine HCl, Phenylephrine HCl, and Codeine Phosphate Syrup[2].

Market Leaders and Profiles

  • Other market leaders include companies that specialize in pharmaceuticals and have a strong presence in the cough and cold segment. These companies invest heavily in R&D to develop new and effective combination therapies[1].

Regulatory Environment

The regulatory environment plays a crucial role in shaping the market.

Controlled Substance Status

  • Promethazine with Codeine is classified as a Schedule V controlled substance, which means it has a lower potential for abuse compared to Schedule IV substances but is still subject to strict regulations[5].

FDA Approvals and Guidelines

  • Products like Promethazine VC with Codeine require FDA approval, and their use is governed by specific guidelines to minimize the risk of abuse and side effects[4].

Pricing and Sales

The pricing of Promethazine-Codeine solutions can vary based on several factors, including the region, brand, and generic status.

Market Sales

  • According to IMS Health, branded and generic sales of Promethazine/Phenylephrine/Codeine Syrup were approximately $16 million for the twelve months ended July 31, 2015[2].

Street Value and Abuse

  • The street value of such medications can be significant, with narcotic drugs like codeine having a wide price range due to their potential for abuse. This highlights the need for stringent regulatory measures to prevent misuse[3].

Safety and Side Effects

The use of Promethazine-Codeine solutions comes with significant safety concerns.

Respiratory Depression

  • Life-threatening respiratory depression and death have been reported, especially in pediatric patients who are ultra-rapid metabolizers of codeine due to a CYP2D6 polymorphism[4].

Contraindications

  • The solution is contraindicated in children under 12 years of age and in adolescents 12 to 18 years of age following tonsillectomy or adenoidectomy. Adults must also be carefully assessed for the risks of addiction, abuse, and misuse[4].

Dosage and Administration

The dosage of Promethazine VC with Codeine is strictly regulated.

Adult Dosage

  • Adults are advised to take 5 mL every 4 to 6 hours as needed, not to exceed 6 doses (30 mL) in 24 hours. The solution must be measured with an accurate milliliter measuring device[4].

Monitoring and Reevaluation

  • Patients must be regularly monitored for the development of addiction or abuse, and the need for continued treatment must be reevaluated before refilling prescriptions[4].

Key Takeaways

  • The Promethazine-Codeine solution market is driven by the increasing incidence of respiratory symptoms and R&D investments in combination therapies.
  • The market is segmented by product and application, with strict regulations governing its use.
  • Key players like Akorn, Inc. play a significant role in the market.
  • Safety concerns, particularly regarding respiratory depression and potential for abuse, are critical factors.
  • The market is expected to grow at a significant CAGR from 2023 to 2031.

Frequently Asked Questions (FAQs)

1. What are the primary indications for Promethazine VC with Codeine Oral Solution?

  • Promethazine VC with Codeine Oral Solution is indicated for the temporary relief of coughs and upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold in patients 18 years of age and older[4].

2. Why is Promethazine VC with Codeine contraindicated in pediatric patients?

  • It is contraindicated due to the risk of life-threatening respiratory depression, especially in children who are ultra-rapid metabolizers of codeine[4].

3. What are the key market drivers for the Promethazine-Codeine solution market?

  • Increasing incidences of common cold, allergies, and fever, along with rising awareness and R&D investments in combination therapies, drive the market[1].

4. How is the Promethazine-Codeine solution market segmented?

  • The market is segmented by product (e.g., Promethazine HCl and Codeine Phosphate Syrup) and application (adults and children, with strict regulations for pediatric use)[1].

5. What are the safety concerns associated with Promethazine VC with Codeine?

  • The solution poses risks of respiratory depression, addiction, abuse, and misuse. It is contraindicated in certain pediatric populations and requires careful assessment and monitoring in adults[4].

Cited Sources:

  1. The Insight Partners. DXM and Codeine Syrup Market Opportunities 2031.
  2. BioSpace. Akorn, Inc. Launches Two Additional Promethazine Syrup Formulations.
  3. PubMed. The street value of prescription drugs.
  4. Drugs.com. Promethazine VC with Codeine: Package Insert / Prescribing Info.
  5. California State Board of Pharmacy. Decision and Order.

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