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Last Updated: April 3, 2025

PROMETHAZINE VC W/ CODEINE Drug Patent Profile


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

Promethazine Vc W/ Codeine is a drug marketed by Cenci and Wockhardt and is included in two NDAs.

The generic ingredient in PROMETHAZINE 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 PROMETHAZINE VC W/ CODEINE
Drug patent expirations by year for PROMETHAZINE VC W/ CODEINE

US Patents and Regulatory Information for PROMETHAZINE VC W/ CODEINE

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Cenci PROMETHAZINE VC W/ CODEINE codeine phosphate; phenylephrine hydrochloride; promethazine hydrochloride SYRUP;ORAL 088816-001 Nov 22, 1985 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Wockhardt PROMETHAZINE VC W/ CODEINE codeine phosphate; phenylephrine hydrochloride; promethazine hydrochloride SYRUP;ORAL 088896-001 Jan 4, 1985 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 2 of 2 entries

Market Dynamics and Financial Trajectory for Promethazine VC with Codeine

Introduction

Promethazine VC with Codeine is a combination medication consisting of codeine, an opioid agonist; promethazine, a phenothiazine; and phenylephrine, an alpha-1 adrenergic receptor agonist. This medication is indicated for the temporary relief of cough and upper respiratory symptoms in adults. Here, we delve into the market dynamics and financial trajectory of this drug.

Market Drivers

The market for Promethazine VC with Codeine and similar cough syrups is driven by several key factors:

Increasing Incidences of Common Cold and Allergies

The global prevalence of common colds and allergies continues to rise, leading to an increased demand for over-the-counter (OTC) and prescription cough medications. This trend is expected to fuel the growth of the DXM and Codeine Syrup market, which includes products like Promethazine VC with Codeine[3].

Rising Awareness and Self-Treatment

There is a growing awareness among consumers about treating common cold and cough symptoms at home. This has led to an increase in the demand for cough preparations, including those containing codeine and promethazine[3].

R&D Investments

Pharmaceutical companies are investing heavily in research and development to create various combination drug remedies for cough and cold symptoms. This investment is expected to drive innovation and growth in the market[3].

Market Restraints

Despite the driving factors, there are several restraints that impact the market dynamics:

Drug Abuse and Misuse

The potential for drug abuse and misuse, particularly with codeine-containing preparations, is a significant concern. Long-term use of promethazine and codeine can lead to tolerance, dependence, and addiction, which has been highlighted by public health agencies such as the FDA[2][4].

Regulatory Restrictions

Cough syrups containing promethazine and codeine are approved for distribution only under the supervision of a licensed practitioner. This regulatory oversight can limit the accessibility and thus the market growth of these medications[4].

Serious Side Effects

The medication carries serious risks, including life-threatening respiratory depression, especially in pediatric patients and those who are ultra-rapid metabolizers of codeine. These risks have led to contraindications and warnings that can affect market demand[1][5].

Market Segmentation

The market for DXM and Codeine Syrup, which includes Promethazine VC with Codeine, is segmented based on product and application:

Product Segmentation

The market is segmented into DXM and promethazine-codeine cough syrups. Promethazine VC with Codeine falls under the latter category[3].

Application Segmentation

The primary application is in adults, as the medication is contraindicated in children under 18 years of age, especially following tonsillectomy and/or adenoidectomy[1][3].

Regional Framework

The market is analyzed across various regions, including North America, Europe, Asia-Pacific, Middle East and Africa, and South & Central America. Each region has its own market dynamics influenced by local regulations, healthcare policies, and consumer behavior[3].

Financial Trajectory

The financial trajectory of the market for Promethazine VC with Codeine and similar products is expected to be influenced by the following factors:

Market Size and Growth

The DXM and Codeine Syrup market is projected to witness high growth during the forecast period from 2024 to 2031, driven by increasing demand and R&D investments. However, the exact market size and growth rate for Promethazine VC with Codeine specifically would depend on its generic availability and competition within the market[3].

Revenue Forecast

The revenue forecast for the broader DXM and Codeine Syrup market indicates a significant increase, with a projected CAGR from 2023 to 2031. However, the financial performance of Promethazine VC with Codeine will be impacted by its discontinued brand status and the availability of generic equivalents[3].

Competitive Landscape

The competitive landscape includes various pharmaceutical companies focusing on organic and inorganic growth strategies such as product launches, acquisitions, and partnerships. Companies engaged in the DXM and Codeine Syrup market are anticipated to have lucrative growth opportunities, but the specific competitive dynamics for Promethazine VC with Codeine will be influenced by its regulatory and market status[3].

Regulatory Impact

The FDA's regulatory actions, including the discontinuation of certain brand names due to abuse and the issuance of warnings about pediatric use, significantly impact the market. The requirement for distribution under the supervision of a licensed practitioner further regulates the market[1][4].

Consumer Behavior and Abuse

The recreational use of Promethazine VC with Codeine, often referred to as "lean" or "sizzurp," has been a significant concern. This misuse has led to increased scrutiny and regulatory measures, affecting the market dynamics and financial trajectory of the drug[2][4].

Key Takeaways

  • Market Drivers: Increasing incidences of common cold and allergies, rising awareness and self-treatment, and R&D investments drive the market.
  • Market Restraints: Drug abuse and misuse, regulatory restrictions, and serious side effects are significant restraints.
  • Market Segmentation: The market is segmented by product and application, with a focus on adult use.
  • Financial Trajectory: The market is expected to grow, but the financial performance of Promethazine VC with Codeine will be impacted by its discontinued brand status and regulatory environment.
  • Competitive Landscape: Pharmaceutical companies employ various growth strategies, but the competitive dynamics for Promethazine VC with Codeine are influenced by regulatory and market factors.

FAQs

  1. What is Promethazine VC with Codeine used for? Promethazine VC 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 patients 18 years of age and older[1].

  2. Why has the brand name of Promethazine VC with Codeine been discontinued? The brand name has been discontinued due to widespread abuse and misuse, leading to regulatory actions by the FDA[1][4].

  3. What are the serious side effects of Promethazine VC with Codeine? Serious side effects include life-threatening respiratory depression, especially in pediatric patients and those who are ultra-rapid metabolizers of codeine[1][5].

  4. Can Promethazine VC with Codeine be used in children? No, Promethazine VC with Codeine is contraindicated in children younger than 12 years of age and in children younger than 18 years of age following tonsillectomy and/or adenoidectomy[1].

  5. How is the market for Promethazine VC with Codeine expected to grow? The market is expected to grow due to increasing demand and R&D investments, but the financial performance of Promethazine VC with Codeine will be impacted by its regulatory environment and discontinued brand status[3].

Cited Sources

  1. Drugs.com: Promethazine VC with Codeine: Package Insert / Prescribing Info.
  2. PLOS ONE: Exploratory study on “lean” or “sizzurp” using national survey data.
  3. The Insight Partners: DXM and Codeine Syrup Market Opportunities 2031.
  4. Federal Register: Cough syrups containing promethazine and codeine.
  5. Wikipedia: Codeine.

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