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Last Updated: April 11, 2025

PHENERGAN W/ CODEINE Drug Patent Profile


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When do Phenergan W/ Codeine patents expire, and what generic alternatives are available?

Phenergan W/ Codeine is a drug marketed by Ani Pharms and is included in one NDA.

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

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Summary for PHENERGAN W/ CODEINE
US Patents:0
Applicants:1
NDAs:1
DailyMed Link:PHENERGAN W/ CODEINE at DailyMed
Drug patent expirations by year for PHENERGAN W/ CODEINE

US Patents and Regulatory Information for PHENERGAN W/ CODEINE

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Ani Pharms PHENERGAN W/ CODEINE codeine phosphate; promethazine hydrochloride SYRUP;ORAL 008306-004 Apr 2, 1984 DISCN Yes 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 Phenergan with Codeine

Introduction

Phenergan with Codeine, a combination of promethazine and codeine, is a medication used for the temporary relief of cough and upper respiratory symptoms. Understanding the market dynamics and financial trajectory of this drug is crucial for pharmaceutical companies, investors, and healthcare professionals.

Market Drivers

The market for Phenergan with Codeine and similar cough and cold medications is driven by several key factors:

Increasing Incidences of Common Cold and Allergies

The global prevalence of common colds, allergies, and fever continues to rise, driving the demand for over-the-counter (OTC) and prescription cough and cold medications. This trend is expected to fuel the growth of the DXM and Codeine Syrup market, which includes Phenergan with Codeine[4].

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 OTC cough preparations, including those containing codeine and promethazine[4].

R&D Investments

Pharmaceutical companies are investing heavily in research and development to create various combination drug remedies for cough and cold symptoms. These investments are expected to contribute to the market growth of Phenergan with Codeine and similar products[4].

Market Restraints

Despite the market drivers, there are several restraints that affect the financial trajectory of Phenergan with Codeine:

Drug Abuse and Misuse

Codeine-containing preparations, including Phenergan with Codeine, are subject to misuse and abuse. This has led to strict regulatory measures and warnings, which can limit market growth. For instance, the FDA has issued contraindications for the use of codeine in children under 12 years and in certain surgical contexts[1][5].

Potential Side Effects

The use of codeine and promethazine is associated with serious side effects, such as respiratory depression, especially in children. These risks have led to stricter prescribing guidelines and monitoring, which can impact market demand[1][5].

Market Segmentation

The market for Phenergan with Codeine is segmented based on product and application:

Product Segmentation

The market is segmented into different types of cough and cold medications, including DXM and promethazine-codeine cough syrups. Phenergan with Codeine falls under the category of promethazine-codeine cough syrups[4].

Application Segmentation

The market is segmented into adult and pediatric applications. However, due to the FDA's contraindications, Phenergan with Codeine is not indicated for pediatric patients under 18 years of age[5].

Regional Framework

The global market for Phenergan with Codeine 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[4].

Financial Trajectory

The financial trajectory of Phenergan with Codeine is influenced by several factors:

Market Size and Growth

The DXM and Codeine Syrup market, which includes Phenergan with Codeine, is expected to witness significant growth from 2023 to 2031, driven by increasing demand and R&D investments. The market size is projected to grow at a CAGR of XX% during this period[4].

Revenue Forecast

The revenue forecast for the market indicates a substantial increase, with the global market size expected to reach US$ XX Million by 2031. Historical data from 2021-2022 and forecast data from 2024-2031 provide a comprehensive view of the market's financial trajectory[4].

Key Market Players

Several pharmaceutical companies are involved in the production and distribution of Phenergan with Codeine. These companies focus on organic and inorganic growth strategies, such as product launches, acquisitions, and partnerships, to expand their market share and customer base[4].

Regulatory Environment

The regulatory environment plays a critical role in shaping the market dynamics of Phenergan with Codeine:

FDA Regulations

The FDA has imposed strict regulations on the use of codeine and tramadol in children, including contraindications for certain age groups and surgical contexts. These regulations have significant implications for the prescribing and use of Phenergan with Codeine[1].

Safety Warnings

The FDA has issued warnings about the risks associated with codeine, including addiction, abuse, and life-threatening respiratory depression. These warnings are included in the drug labels and prescribing information for Phenergan with Codeine[1][5].

Consumer Behavior and Misuse

Consumer behavior, particularly the misuse of cough and cold medications, affects the market:

Lean or Sizzurp

The misuse of promethazine-codeine cough syrups, often mixed with other substances like Sprite to create "lean" or "sizzurp," is a significant concern. This misuse can lead to serious health risks and regulatory actions that impact market demand[3].

Key Takeaways

  • The market for Phenergan with Codeine is driven by increasing incidences of common cold and allergies, rising awareness of self-treatment, and R&D investments.
  • Market growth is restrained by drug abuse and misuse, potential side effects, and strict regulatory measures.
  • The market is segmented by product and application, with Phenergan with Codeine not indicated for pediatric patients.
  • The financial trajectory indicates significant growth, with a projected CAGR of XX% from 2023 to 2031.
  • Regulatory environment and consumer behavior play crucial roles in shaping the market dynamics.

Frequently Asked Questions (FAQs)

Q1: What are the primary indications for Phenergan with Codeine? Phenergan with Codeine is indicated 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[5].

Q2: Why has the FDA restricted the use of codeine in children? The FDA has restricted the use of codeine in children due to the risk of life-threatening respiratory depression. There have been reported cases of respiratory depression and deaths associated with codeine use in children[1].

Q3: What are the potential side effects of Phenergan with Codeine? Potential side effects include respiratory depression, addiction, abuse, and misuse. Other risks include medication errors, interactions with other drugs, and neonatal opioid withdrawal syndrome[5].

Q4: How does the misuse of Phenergan with Codeine impact the market? The misuse of Phenergan with Codeine, such as creating "lean" or "sizzurp," can lead to serious health risks and regulatory actions, which can limit market demand and growth[3].

Q5: What is the expected market growth for Phenergan with Codeine from 2023 to 2031? The market for Phenergan with Codeine is expected to witness significant growth, with a projected CAGR of XX% from 2023 to 2031, driven by increasing demand and R&D investments[4].

Cited Sources

  1. FDA Drug Safety Communication: FDA restricts use of prescription codeine pain and cough medicines and tramadol pain medicines in children.
  2. Maryland State Board of Pharmacy: Formal Orders - McMichael, L.
  3. PLOS ONE: Exploratory study on “lean” or “sizzurp” using national survey data.
  4. The Insight Partners: DXM and Codeine Syrup Market Opportunities 2031.
  5. Drugs.com: Promethazine VC with Codeine: Package Insert / Prescribing Info.

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