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Last Updated: April 8, 2025

ACTIFED W/ CODEINE Drug Patent Profile


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Which patents cover Actifed W/ Codeine, and when can generic versions of Actifed W/ Codeine launch?

Actifed W/ Codeine is a drug marketed by Glaxosmithkline and is included in one NDA.

The generic ingredient in ACTIFED W/ CODEINE is codeine phosphate; pseudoephedrine hydrochloride; triprolidine hydrochloride. There are nineteen drug master file entries for this compound. Additional details are available on the codeine phosphate; pseudoephedrine hydrochloride; triprolidine hydrochloride profile page.

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

US Patents and Regulatory Information for ACTIFED W/ CODEINE

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Glaxosmithkline ACTIFED W/ CODEINE codeine phosphate; pseudoephedrine hydrochloride; triprolidine hydrochloride SYRUP;ORAL 012575-003 Apr 4, 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 Actifed with Codeine

Introduction

Actifed with Codeine is a medication that combines the antihistamine triprolidine, the decongestant pseudoephedrine, and the opioid codeine to relieve symptoms of the common cold, such as cough, sneezing, runny or itchy nose, and nasal congestion. To understand the market dynamics and financial trajectory of this drug, it is essential to delve into various factors influencing its demand, competition, and regulatory environment.

Market Size and Growth

The market for codeine-containing medications, including Actifed with Codeine, is part of the broader opioid and cough and cold markets. As of 2023, the global codeine market was valued at USD 2 billion and is projected to reach USD 3 billion by 2031, growing at a Compound Annual Growth Rate (CAGR) of 4.1% from 2024 to 2031[3].

Drivers of Demand

Several factors drive the demand for Actifed with Codeine:

Rising Prevalence of Respiratory Disorders

The increasing incidence of respiratory diseases such as asthma, chronic obstructive pulmonary disease (COPD), and other respiratory conditions contributes significantly to the demand for codeine-based cough relief medications[3].

Chronic Pain Management

Codeine is also widely used for pain management, particularly for mild to moderately severe pain. The growing need for effective pain management solutions further boosts the market for codeine-containing drugs[3].

Improvements in Formulation and Administration

Advancements in medication composition and administration techniques enhance patient compliance and efficacy, thereby increasing the demand for these medications[3].

Market Segmentation

The codeine market, which includes Actifed with Codeine, is segmented based on several criteria:

By Application

  • Codeine tablets
  • Codeine syrup
  • Codeine capsules

By Product

  • Pain management
  • Cough relief
  • Postoperative care
  • Respiratory therapy

By Geography

  • North America
  • Europe
  • Asia-Pacific
  • South America
  • Middle East and Africa[3].

Competitive Landscape

The market for codeine-containing medications is competitive, with several key players:

Major Manufacturers

Companies such as Pfizer, Mylan, Teva, Mallinckrodt, Sun Pharma, AbbVie, Merck, J&J, Hikma Pharmaceuticals, and Alvogen are prominent in the codeine market[3].

Market Dynamics

The competitive landscape is influenced by factors such as buyers' bargaining power, suppliers' bargaining power, the threat of new entrants, the threat of substitutes, and the degree of competition within the market. A Porter’s Five Forces analysis provides a comprehensive view of these dynamics[3].

Regulatory Environment

The regulatory environment plays a crucial role in shaping the market for Actifed with Codeine:

FDA Approvals and Guidelines

For instance, the FDA has approved various codeine-containing products, including codeine sulfate oral solution, with specific recommendations for postmarket risk evaluation and mitigation strategies[4].

Safety and Efficacy

Regulatory bodies closely monitor the safety and efficacy of codeine-containing medications. The FDA has conducted extensive reviews to ensure that the benefits of these medications outweigh the risks, particularly in terms of opioid-related adverse effects[4].

Financial Trajectory

The financial trajectory of Actifed with Codeine is closely tied to the overall codeine market:

Revenue Projections

Given the projected growth of the codeine market from USD 2 billion in 2023 to USD 3 billion by 2031, Actifed with Codeine is likely to contribute significantly to this revenue growth[3].

Prescription Rates and Healthcare Infrastructure

Increasing prescription rates and the expansion of global healthcare infrastructure are key drivers of the financial growth in this market. As healthcare systems become more accessible and advanced, the demand for effective medications like Actifed with Codeine is expected to rise[3].

Impact of Global Health Trends

Global health trends, such as the rising prevalence of chronic diseases and the need for effective pain and cough management, continue to influence the market dynamics of Actifed with Codeine.

Chronic Pain and Respiratory Diseases

The increasing incidence of chronic pain and respiratory diseases globally drives the demand for medications that can effectively manage these conditions. Codeine, being a versatile opioid, plays a significant role in this context[3].

Challenges and Opportunities

While the market for Actifed with Codeine presents several opportunities, it also faces challenges:

Opioid Safety Concerns

One of the significant challenges is the safety concern associated with opioid use. Regulatory bodies and healthcare providers are increasingly cautious about the potential for opioid misuse and addiction. This has led to stricter regulations and monitoring of opioid-containing medications[4].

Innovations in Formulations

On the other hand, innovations in formulations and administration techniques offer opportunities for growth. Improved formulations can enhance patient compliance and reduce the risk of adverse effects, making these medications more appealing to both patients and healthcare providers[3].

Key Takeaways

  • The global codeine market, including Actifed with Codeine, is projected to grow from USD 2 billion in 2023 to USD 3 billion by 2031.
  • The demand is driven by the rising prevalence of respiratory disorders and chronic pain.
  • Improvements in medication composition and administration techniques are crucial for market growth.
  • The competitive landscape is influenced by major manufacturers and regulatory dynamics.
  • Opioid safety concerns are a significant challenge, while innovations in formulations present opportunities.

FAQs

Q: What are the primary drivers of the demand for Actifed with Codeine?

A: The primary drivers include the rising prevalence of respiratory disorders, the need for chronic pain management, and improvements in medication composition and administration techniques.

Q: Which companies are major players in the codeine market?

A: Major players include Pfizer, Mylan, Teva, Mallinckrodt, Sun Pharma, AbbVie, Merck, J&J, Hikma Pharmaceuticals, and Alvogen.

Q: What is the projected growth rate of the codeine market from 2024 to 2031?

A: The codeine market is expected to grow at a CAGR of 4.1% from 2024 to 2031.

Q: What are the main segments of the codeine market?

A: The market is segmented by application (codeine tablets, syrup, capsules), product (pain management, cough relief, postoperative care, respiratory therapy), and geography (North America, Europe, Asia-Pacific, etc.).

Q: What are the regulatory challenges faced by Actifed with Codeine?

A: Regulatory challenges include ensuring the safety and efficacy of the medication, particularly in relation to opioid-related adverse effects, and complying with postmarket risk evaluation and mitigation strategies.

Sources

  1. Federal Register, Volume 62 Issue 107 - FDA analysis on ephedrine alkaloid-containing dietary supplements.
  2. Mayo Clinic - Cough and cold combinations (oral route).
  3. Market Research Intellect - Codeine Market Size and Projections.
  4. FDA - Approval and clinical review of Codeine Sulfate Oral Solution.
  5. Mayo Clinic - Triprolidine, pseudoephedrine, and codeine (oral route).

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