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Last Updated: December 27, 2024

CODEINE SULFATE Drug Patent Profile


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When do Codeine Sulfate patents expire, and when can generic versions of Codeine Sulfate launch?

Codeine Sulfate is a drug marketed by Hikma and Lannett Co Inc and is included in three NDAs.

The generic ingredient in CODEINE SULFATE is codeine sulfate. There are nineteen drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the codeine sulfate profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Codeine Sulfate

A generic version of CODEINE SULFATE was approved as codeine sulfate by HIKMA on July 16th, 2009.

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Summary for CODEINE SULFATE
Drug patent expirations by year for CODEINE SULFATE
Drug Prices for CODEINE SULFATE

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Recent Clinical Trials for CODEINE SULFATE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
University of Sao Paulo General HospitalPhase 3
Aristotle University Of ThessalonikiPhase 4
Roxane LaboratoriesPhase 3

See all CODEINE SULFATE clinical trials

Pharmacology for CODEINE SULFATE
Drug ClassOpioid Agonist
Mechanism of ActionFull Opioid Agonists
Medical Subject Heading (MeSH) Categories for CODEINE SULFATE

US Patents and Regulatory Information for CODEINE SULFATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hikma CODEINE SULFATE codeine sulfate SOLUTION;ORAL 202245-001 Jun 30, 2011 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Lannett Co Inc CODEINE SULFATE codeine sulfate TABLET;ORAL 203046-003 Jun 13, 2014 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Hikma CODEINE SULFATE codeine sulfate TABLET;ORAL 022402-003 Jul 16, 2009 AB RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Hikma CODEINE SULFATE codeine sulfate TABLET;ORAL 022402-001 Jul 16, 2009 AB RX Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Hikma CODEINE SULFATE codeine sulfate TABLET;ORAL 022402-002 Jul 16, 2009 AB RX Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Lannett Co Inc CODEINE SULFATE codeine sulfate TABLET;ORAL 203046-002 Jun 13, 2014 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

CODEINE SULFATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Codeine Sulfate

Introduction

Codeine sulfate, a widely used opioid analgesic, is integral in the management of pain, cough, and diarrhea. The market for codeine sulfate is complex, influenced by various factors including regulatory environments, demographic changes, and technological advancements.

Market Drivers

Several key factors drive the growth of the codeine sulfate market:

Increasing Prevalence of Chronic Pain and Cough Conditions

The rising incidence of chronic pain and respiratory ailments, such as coughs, is a significant driver. As the global population ages, the demand for effective pain management and cough suppression solutions increases, bolstering the market for codeine sulfate[1][3].

Availability of Structured Regulatory Frameworks

Regulatory frameworks that ensure the safe distribution of controlled substances like codeine sulfate provide a stable environment for market growth. These frameworks help in mitigating the risks associated with opioid misuse while ensuring that legitimate medical needs are met[1].

Growing Geriatric Population

The increasing geriatric population, which is more prone to chronic diseases such as cancer, arthritis, and cardiovascular diseases, contributes to the demand for opioid medications, including codeine sulfate. This demographic shift is expected to continue driving market growth[3].

Market Restraints

Despite the drivers, several restraints impact the market:

High Costs of Production and Commercialization

The high costs associated with the production and commercialization of codeine sulfate can be a significant barrier. These costs can affect the profitability of pharmaceutical companies and limit market expansion[1].

Strict Regulatory Controls

Stringent regulatory controls aimed at preventing misuse and addiction of opioids, including codeine sulfate, can restrict market growth. These regulations often lead to stricter prescribing practices and increased scrutiny over opioid use[1][5].

Side Effects and Misuse

The potential for serious side effects such as respiratory depression, constipation, and addiction, as well as the misuse of codeine sulfate, are significant restraints. These issues can lead to reduced prescriptions and increased regulatory oversight[2][4].

Market Opportunities

Several opportunities exist for the codeine sulfate market:

Collaborative Developments

Collaborations between pharmaceutical companies and research institutions can lead to innovative and efficient uses of codeine sulfate. These partnerships can result in new formulations and applications, expanding the market[1].

Advancements in Controlled-Release Formulations

Technological advancements in controlled-release formulations can enhance patient compliance and reduce the risk of misuse. These innovations can make codeine sulfate more appealing to both patients and healthcare providers[1].

Market Challenges

The codeine sulfate market faces several challenges:

Prevalence of Counterfeit Products

The presence of counterfeit products containing codeine sulfate poses a significant risk to public health and market integrity. Efforts to combat counterfeiting are crucial for maintaining consumer trust and ensuring the safe use of the drug[1].

Regulatory Scrutiny

The ongoing scrutiny over opioid prescribing practices and the strict regulatory environment can limit market growth. Companies must navigate these challenges while ensuring compliance with evolving regulations[1][5].

Market Segmentation

The codeine sulfate market can be segmented in several ways:

Formulation

Codeine sulfate is available in various formulations, including capsules, syrups, and tablets. Syrups are often preferred due to higher patient compliance, especially among pediatric and geriatric populations[1].

Grade

The market is segmented into laboratory grade and pharmaceutical grade codeine sulfate. Pharmaceutical grade is the dominant segment due to its widespread use in medical applications[1].

Application

Codeine sulfate is used for cough suppression, diarrhea suppression, and pain management. Pain management is the largest application segment, driven by the increasing need for effective pain relief solutions[1][3].

Distribution Channel

The distribution channels include offline and online segments, with offline channels such as hospitals, clinics, and pharmacies being the primary distribution points[1].

Geographical Analysis

The global codeine sulfate market is analyzed across various regions, including the Americas, Asia-Pacific, and Europe, Middle East & Africa. North America is a significant market due to the high prevalence of chronic pain and the well-established healthcare infrastructure[1][3].

Financial Trajectory

The financial trajectory of the codeine sulfate market is characterized by steady growth:

Market Size and Growth Rate

The global opioids market, which includes codeine sulfate, was valued at USD 5.4 billion in 2022 and is expected to reach USD 7.7 billion by 2032, growing at a CAGR of 3.7% during the forecast period[3].

Revenue Forecast

The revenue from codeine sulfate is expected to increase due to the rising demand for pain management solutions and the growing geriatric population. However, this growth will be tempered by regulatory controls and the high costs of production[1][3].

Key Players and Competitive Landscape

The competitive landscape of the codeine sulfate market includes several key players involved in the production and distribution of the drug. These companies must navigate the complex regulatory environment while innovating to stay competitive. Porter’s Five Forces Analysis and PESTLE Analysis provide insights into the competitive dynamics and external factors influencing the market[1].

Technological Advancements

Technological advancements, particularly in controlled-release formulations, are expected to play a crucial role in the future of the codeine sulfate market. These innovations can improve patient compliance, reduce the risk of misuse, and enhance the overall efficacy of the drug[1].

Regulatory Environment

The regulatory environment is a critical factor in the codeine sulfate market. Strict regulations and guidelines issued by health authorities aim to balance the medical need for opioids with the risk of misuse and addiction. Companies must comply with these regulations to ensure market access and consumer safety[1][5].

Consumer Behavior and Preferences

Consumer behavior and preferences also influence the market. Patients increasingly prefer formulations that offer better compliance and fewer side effects, driving the demand for innovative products. Understanding consumer behavior is essential for pharmaceutical companies to develop strategies that meet patient needs effectively[1].

Key Takeaways

  • The codeine sulfate market is driven by the increasing prevalence of chronic pain and cough conditions, as well as the growing geriatric population.
  • Strict regulatory controls and high production costs are significant restraints.
  • Innovations in controlled-release formulations and collaborative developments offer market opportunities.
  • The market is segmented by formulation, grade, application, and distribution channel.
  • The financial trajectory indicates steady growth, with the global opioids market expected to reach USD 7.7 billion by 2032.
  • Technological advancements and regulatory compliance are crucial for market success.

Frequently Asked Questions (FAQs)

Q: What are the primary applications of codeine sulfate? A: Codeine sulfate is primarily used for pain management, cough suppression, and diarrhea suppression[1][3].

Q: What are the common side effects of codeine sulfate? A: Common side effects include constipation, nausea, vomiting, and drowsiness. Serious side effects can include respiratory depression and addiction[2][4].

Q: How does the regulatory environment impact the codeine sulfate market? A: The regulatory environment significantly impacts the market through strict controls aimed at preventing misuse and addiction, which can limit market growth but ensure safe use[1][5].

Q: What are the key drivers of the codeine sulfate market? A: The key drivers include the increasing prevalence of chronic pain and cough conditions, the growing geriatric population, and the availability of structured regulatory frameworks[1][3].

Q: What technological advancements are expected to influence the codeine sulfate market? A: Advancements in controlled-release formulations are expected to enhance patient compliance and reduce the risk of misuse, driving market growth[1].

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