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Last Updated: April 11, 2025

PHERAZINE VC W/ CODEINE Drug Patent Profile


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Which patents cover Pherazine Vc W/ Codeine, and what generic alternatives are available?

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

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

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

US Patents and Regulatory Information for PHERAZINE VC W/ CODEINE

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Halsey PHERAZINE VC W/ CODEINE codeine phosphate; phenylephrine hydrochloride; promethazine hydrochloride SYRUP;ORAL 088870-001 Mar 2, 1987 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>TE>Type>RLD>RS>Patent No.>Patent Expiration>Product>Substance>Delist Req.>Exclusivity Expiration
Showing 1 to 1 of 1 entries

Market Dynamics and Financial Trajectory for Promethazine VC with Codeine

Introduction

Promethazine VC with Codeine is a combination drug used for the temporary relief of cough and upper respiratory symptoms associated with allergies or the common cold. This article delves into the market dynamics, financial trajectory, and key factors influencing the market for this drug.

Market Overview

The market for DXM (Dextromethorphan) and codeine syrups, which includes Promethazine VC with Codeine, is experiencing significant growth driven by several key factors.

  • Increasing Incidence of Common Cold and Allergies: The rising incidence of common cold, allergies, and fever globally is a major driver. As more people seek over-the-counter (OTC) solutions for these conditions, the demand for cough and cold medications increases[1].
  • R&D Investments: Pharmaceutical companies are investing heavily in research and development to create various combination drug remedies for cough and cold, further fueling market growth[1].

Market Segmentation

The market for Promethazine VC with Codeine is segmented based on product and application.

  • Product Segmentation: The market includes products like DXM and Promethazine-codeine cough syrup. Promethazine VC with Codeine Oral Solution is a specific product that combines codeine, promethazine, and phenylephrine[1][4].
  • Application Segmentation: The primary applications are for adults and children, although Promethazine VC with Codeine is not indicated for pediatric patients under 18 years of age due to safety concerns[1][4].

Regional Framework

The market is analyzed across several major regions, including 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 high healthcare spending and a large consumer base seeking OTC and prescription medications for cough and cold symptoms[1].
  • Global Reach: The market is expected to grow in other regions as well, driven by increasing healthcare awareness and the availability of these medications[1].

Financial Trajectory

The financial outlook for Promethazine VC with Codeine and similar products is promising but comes with certain challenges.

  • Market Size and Growth: The codeine market, which includes Promethazine VC with Codeine, was valued at USD 3.93 billion in 2023 and is expected to reach USD 5.40 billion by 2030, growing at a CAGR of 4.65%[3].
  • Revenue Forecast: The DXM and codeine syrup market is also expected to witness high growth, with a projected CAGR from 2023 to 2031, although the exact figures vary by report[1].

Key Drivers

Several factors drive the market growth for Promethazine VC with Codeine:

  • Increasing Demand for Pain Management: The necessity of codeine in pain management and its efficacy in providing relief for mild to moderate pain contribute significantly to market growth[3].
  • OTC Availability: Many cough preparations, including those containing codeine, are available OTC, increasing consumer access and driving demand[1].
  • R&D and Innovation: Pharmaceutical companies are focusing on developing safer, less addictive codeine formulations and exploring alternative natural sources, which could enhance market growth[3].

Challenges and Restraints

Despite the growth potential, there are several challenges facing the market:

  • Drug Abuse and Misuse: The risk of addiction, abuse, and misuse, particularly with codeine-containing preparations, is a significant restraint. This has led to stricter regulations and increased scrutiny[1][2][4].
  • Respiratory Depression Risks: Serious and life-threatening respiratory depression, especially in children, is a major concern. This has resulted in contraindications for pediatric use and strict monitoring requirements[2][4].
  • Regulatory Limitations: The opioid crisis has led to stricter regulations, negatively impacting the expansion of the codeine market. Compliance with evolving legal landscapes is crucial for market players[3].

Market Players and Strategies

Key players in the market are adopting various strategies to maintain and expand their market presence.

  • Organic Growth: Companies are focusing on product launches, product approvals, and other organic growth strategies[1].
  • Inorganic Growth: Acquisitions, partnerships, and collaborations are also common strategies to expand business and customer base[1].
  • Patient Education: Investing in patient education programs to enhance safe use awareness is another strategy to address societal concerns and build a loyal consumer base[3].

Regional Analysis and PEST Factors

The market is influenced by various regional factors:

  • Political Factors: Regulatory changes and legal frameworks significantly impact the market. For example, the discontinuation of the Promethazine VC with Codeine brand name in the U.S. and the availability of generic versions affect market dynamics[4].
  • Economic Factors: Healthcare spending and economic stability in different regions influence the demand for these medications[1].
  • Social Factors: Increasing awareness about treating common cold and cough symptoms at home drives the demand for OTC medications[1].
  • Technological Factors: Advances in pharmaceutical formulation design and synthetic biology could enhance drug delivery methods and production efficiency[3].

Warning and Precautions

Given the risks associated with Promethazine VC with Codeine, several warnings and precautions are in place:

<blockquote>
"Promethazine VC with Codeine Oral Solution exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess patient’s risk before prescribing and monitor closely for these behaviors and conditions."[2]
</blockquote>

Dosage and Administration

The dosage and administration guidelines for Promethazine VC with Codeine are strict to mitigate risks:

  • Adult Dosage: 5 mL every 4 to 6 hours as needed, not to exceed 6 doses (30 mL) in 24 hours[4].
  • Measurement: Use an accurate milliliter measuring device to avoid dosing errors[4].

Key Takeaways

  • The market for Promethazine VC with Codeine is driven by increasing demand for cough and cold medications and R&D investments.
  • The financial trajectory is positive, with a projected CAGR of 4.65% for the codeine market.
  • Challenges include drug abuse and misuse, respiratory depression risks, and regulatory limitations.
  • Market players are adopting various strategies to expand their presence, including organic and inorganic growth and patient education programs.
  • Regional analysis highlights the importance of PEST factors in shaping market dynamics.

FAQs

Q: What are the primary drivers of the Promethazine VC with Codeine market? A: The primary drivers include increasing incidence of common cold and allergies, R&D investments, and the availability of OTC medications.

Q: What are the major challenges facing the Promethazine VC with Codeine market? A: The major challenges include drug abuse and misuse, respiratory depression risks, and regulatory limitations due to the opioid crisis.

Q: Which regions are significant for the Promethazine VC with Codeine market? A: North America, Europe, Asia-Pacific (APAC), Middle East and Africa (MEA), and South & Central America are significant regions.

Q: What strategies are market players adopting to expand their presence? A: Market players are adopting organic growth strategies like product launches and inorganic strategies like acquisitions and partnerships, as well as investing in patient education programs.

Q: Why is Promethazine VC with Codeine not recommended for pediatric use? A: Promethazine VC with Codeine is not recommended for pediatric use due to the risk of life-threatening respiratory depression, especially in children who may be ultra-rapid metabolizers of codeine[2][4].

Cited Sources:

  1. The Insight Partners. DXM and Codeine Syrup Market Opportunities 2031.
  2. DailyMed. Label: PROMETHAZINE VC WITH CODEINE ORAL SOLUTION.
  3. 360iResearch. Codeine Market by Formulation (Capsule, Syrup, Tablet), Grade ...
  4. Drugs.com. Promethazine VC with Codeine: Package Insert / Prescribing Info.

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