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Last Updated: April 5, 2025

PROMETH VC W/ CODEINE Drug Patent Profile


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

Prometh Vc W/ Codeine is a drug marketed by Nostrum Labs Inc and is included in one NDA.

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

US Patents and Regulatory Information for PROMETH VC W/ CODEINE

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Nostrum Labs Inc PROMETH VC W/ CODEINE codeine phosphate; phenylephrine hydrochloride; promethazine hydrochloride SYRUP;ORAL 088764-001 Oct 31, 1984 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 prescription-only oral solution that combines promethazine hydrochloride, phenylephrine hydrochloride, and codeine phosphate. This medication is used to treat coughs and is known for its complex market dynamics due to various factors, including regulatory issues, market demand, and safety concerns.

Market Drivers

Several factors drive the market for Promethazine VC with Codeine and similar cough syrups:

Increasing Incidences of Common Cold and Allergies

The global market for cough syrups, including those containing DXM (dextromethorphan) and codeine, is driven by the increasing incidence of common colds, allergies, and fever. As people become more aware of treating these symptoms, the demand for over-the-counter (OTC) and prescription cough preparations rises[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 fuel market growth by introducing new and more effective treatments[3].

Market Restraints

Despite the drivers, there are significant restraints affecting the market:

Drug Abuse and Misuse

One of the major restraints is the potential for drug abuse and misuse, particularly with codeine-containing preparations. Promethazine VC with Codeine exposes users to risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. This has led to strict regulations and monitoring, limiting its prescription and use[1][4].

Safety Concerns

Life-threatening respiratory depression, especially in children, is a significant concern. The medication is contraindicated in children younger than 12 years and in adolescents who have undergone tonsillectomy and/or adenoidectomy. These safety concerns reduce the market size and limit the patient population[1].

Regulatory Actions

The discontinuation of Promethazine VC with Codeine by Pharmaceutical Associates in January 2024 has significantly impacted the market. As the sole supplier, this discontinuation has led to a shortage of the product, affecting both patients and healthcare providers[5].

Market Segmentation

The market for DXM and codeine syrups, including 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, which includes a combination of promethazine, phenylephrine, and codeine[3].

Application Segmentation

The market is segmented into adult and children applications. However, due to the contraindications and safety concerns, the use in children is highly restricted, making the adult segment the primary market[3].

Regional Framework

The market for DXM and codeine syrups is analyzed across several regions:

North America, Europe, APAC, MEA, and South & Central America

Each region has its own market dynamics influenced by local regulations, healthcare policies, and consumer behavior. The report provides a detailed overview of the industry, including qualitative and quantitative information, and forecasts market size and growth from 2021 to 2031[3].

Financial Trajectory

The financial trajectory of Promethazine VC with Codeine is complex due to the recent discontinuation and ongoing safety concerns:

Historical Performance

Historically, the market for cough syrups, including those with codeine, has seen steady growth driven by increasing demand for cough and cold treatments. However, the specific financial performance of Promethazine VC with Codeine has been impacted by its brand discontinuation and regulatory issues[3].

Current Shortage

The discontinuation by Pharmaceutical Associates has led to a current shortage, affecting the financial performance and availability of the product. This shortage has significant implications for both the manufacturer and the patients who rely on this medication[5].

Future Outlook

Despite the challenges, the overall market for DXM and codeine syrups is expected to witness high growth during the forecast period from 2024 to 2031. However, the future outlook for Promethazine VC with Codeine specifically remains uncertain due to its discontinuation and the need for alternative treatments[3].

Key Players and Market Strategies

The market for DXM and codeine syrups involves several key players who are adopting various strategies to expand their market share:

Organic Growth Strategies

Companies are focusing on product launches, product approvals, and other organic growth strategies to stay competitive. This includes developing new combination drug remedies and investing in R&D[3].

Inorganic Growth Strategies

Inorganic growth strategies such as acquisitions, partnerships, and collaborations are also prevalent. These strategies help companies expand their business and customer base[3].

Conclusion

The market dynamics and financial trajectory for Promethazine VC with Codeine are influenced by a mix of driving and restraining factors. While the demand for cough and cold treatments drives the market, safety concerns, regulatory actions, and the recent discontinuation of the product pose significant challenges.

Key Takeaways

  • Market Drivers: Increasing incidences of common cold and allergies, along with R&D investments by pharmaceutical companies.
  • Market Restraints: Drug abuse and misuse, safety concerns, and regulatory actions.
  • Market Segmentation: Segmented by product (DXM and promethazine-codeine cough syrups) and application (adult and children).
  • Regional Framework: Analyzed across North America, Europe, APAC, MEA, and South & Central America.
  • Financial Trajectory: Impacted by discontinuation and current shortage, with an uncertain future outlook.
  • Key Players and Strategies: Companies adopting organic and inorganic growth strategies to stay competitive.

FAQs

Q: What are the primary components of Promethazine VC with Codeine? A: Promethazine VC with Codeine contains promethazine hydrochloride, phenylephrine hydrochloride, and codeine phosphate.

Q: Why was Promethazine VC with Codeine discontinued? A: Pharmaceutical Associates discontinued Promethazine VC with Codeine in January 2024, although the specific reason is not detailed beyond the discontinuation notice.

Q: What are the safety concerns associated with Promethazine VC with Codeine? A: The medication is associated with risks of addiction, abuse, and misuse, as well as life-threatening respiratory depression, especially in children.

Q: How does the market segmentation affect Promethazine VC with Codeine? A: The market is segmented into adult and children applications, but due to safety concerns, the use in children is highly restricted, making the adult segment the primary market.

Q: What is the future outlook for the DXM and codeine syrup market? A: Despite the challenges faced by Promethazine VC with Codeine, the overall market for DXM and codeine syrups is expected to witness high growth during the forecast period from 2024 to 2031.

Sources

  1. Drugs.com: Promethazine VC with Codeine: Package Insert / Prescribing Info
  2. Adena Health System: Chg Master for Jean - Adena Health System
  3. The Insight Partners: DXM and Codeine Syrup Market Opportunities 2031
  4. PLOS ONE: Exploratory study on “lean” or “sizzurp” using national survey data
  5. ASHP: Promethazine, Phenylephrine, and Codeine Oral Solution - ASHP

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