You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: December 28, 2024

CODEINE Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


AI Research Assistant
Questions you can ask:
  • What is the 5 year forecast for CODEINE?
  • What are the global sales for CODEINE?
  • What is Average Wholesale Price for CODEINE?
Drug patent expirations by year for CODEINE
Drug Prices for CODEINE

See drug prices for CODEINE

US Patents and Regulatory Information for CODEINE

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
Scherer Labs CODEINE, ASPIRIN, APAP FORMULA NO. 2 acetaminophen; aspirin; codeine phosphate CAPSULE;ORAL 085640-001 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

CODEINE Market Analysis and Financial Projection Experimental

Codeine Market Dynamics and Financial Trajectory

Introduction

Codeine, a member of the opioid class, is widely used for managing mild to moderate pain, severe pain, cough, diarrhea, and cold and flu symptoms. Understanding the market dynamics and financial trajectory of codeine is crucial for stakeholders in the pharmaceutical industry.

Market Drivers

Increasing Geriatric Population

The global codeine market is driven significantly by the increasing geriatric population, particularly in regions like North America and Asia-Pacific. This demographic shift leads to a higher prevalence of chronic pain, which in turn increases the demand for codeine formulations. For instance, around 20.4% of adults in the U.S. suffer from chronic pain, and 19.6% of individuals aged 20-60 worldwide experience low back pain[1][4].

Approval and Launch of New Products

The launch of novel codeine products also boosts market growth. For example, Tris Pharma, Inc. received FDA approval for Tuzistra XR, an extended-release oral suspension, in 2015, which is indicated for the treatment of cough and symptoms associated with upper respiratory allergies or a common cold in adults[1].

Growing Demand for Pain Management

The increasing need for effective pain management due to chronic diseases such as cancer, arthritis, and cardiovascular diseases drives the demand for opioids, including codeine. The pain management segment dominates the opioids market, with a market share of around 39% in 2022[4].

Market Restraints

Stringent Regulations

Stringent regulations in key regions are a significant restraint on the codeine market. For example, in Australia, codeine was reclassified as a prescription-only medicine in 2018, which was previously available over-the-counter. Similar regulatory changes in other countries, such as Health Canada's proposal to ban non-prescription codeine sales, are expected to hinder the market's growth[1][2].

Side Effects and Misuse

The side effects associated with opioid use, such as addiction and overdose, also restrain market growth. The misuse of opioids is a global concern, with around 0.5 million individuals dying from drug abuse in 2021, according to the WHO[4].

Regional Analysis

North America

North America holds a dominant position in the global codeine market, driven by the high presence of key players and the approval of new products. This region accounts for the largest market share due to the high prevalence of chronic pain and the availability of advanced healthcare infrastructure[1][4].

Asia-Pacific

The Asia-Pacific region is also expected to contribute significantly to the market growth due to the increasing geriatric population and the rising incidence of chronic diseases. However, disparities in access to essential controlled medicines remain a challenge in this region[1][3].

Financial Trajectory

Market Size and Growth

The global opioids market, which includes codeine, 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% from 2023 to 2032. Codeine, as a part of this market, benefits from this overall growth trend[4].

Revenue Distribution

North America, with a 43% market revenue share in 2022, is the most significant contributor to the global opioids market. The revenue is distributed across various segments, including pain management, cough treatment, and diarrhea treatment, with pain management being the dominant segment[4].

Key Players and Market Competition

Major Players

Key players in the global codeine market include Nexgen Pharma, Inc., Teva Pharmaceutical Industries Ltd., Wraser Pharmaceuticals LLC, Larken Laboratories, Inc., Aurobindo Pharma Limited, Sun Pharmaceutical Industries Limited, Tris Pharma Inc., and Johnson & Johnson. These companies play a crucial role in driving market growth through product innovation and strategic expansions[1].

Competitive Landscape

The market is characterized by intense competition, with companies focusing on research and development to introduce new opioid medications. The concentration of market share among a few large players, such as the top 10 companies holding about 38% of the drug industry’s sales revenue, indicates a competitive yet consolidated market[5].

Economic Impact of Regulatory Changes

Health Economic Model

Regulatory changes, such as the reclassification of codeine to prescription-only status, have significant economic implications. A health economic model developed by KPMG for the Therapeutic Goods Administration (TGA) in Australia estimated that such changes could lead to health gains, deaths prevented, and net financial savings to consumers. However, these changes also result in increased regulatory compliance costs for the pharmaceutical industry[2].

Consumer and Industry Costs

The reclassification of codeine leads to higher costs for consumers who need to purchase more packs to maintain their medication use, as smaller packs are more expensive. This change also results in additional costs for the industry due to the rationalization of product portfolios and compliance with new regulations[2].

Future Outlook

Increasing Demand for Opioids

The growing demand for opioids due to the increasing geriatric population and the rising incidence of chronic diseases is expected to drive the market forward. New product launches and approvals will continue to play a crucial role in market growth[1][4].

Regulatory Challenges

Despite the growth drivers, the market will face challenges from stringent regulations aimed at controlling opioid misuse. Companies will need to adapt to these regulatory changes while ensuring the availability of essential medications for patients in need[1][2].

Key Takeaways

  • The codeine market is driven by the increasing geriatric population and the growing demand for pain management.
  • North America holds a dominant position in the global codeine market.
  • Stringent regulations and side effects associated with opioid use are significant restraints.
  • The global opioids market, including codeine, is expected to grow at a CAGR of 3.7% from 2023 to 2032.
  • Regulatory changes have significant economic implications for both consumers and the pharmaceutical industry.

FAQs

Q: What are the primary drivers of the codeine market? A: The primary drivers include the increasing geriatric population, high prevalence of chronic pain, and the approval and launch of new codeine products.

Q: Which region dominates the global codeine market? A: North America holds the dominant position in the global codeine market due to the high presence of key players and advanced healthcare infrastructure.

Q: What are the major restraints on the codeine market? A: Stringent regulations and the side effects associated with opioid use, including addiction and overdose, are significant restraints.

Q: How is the global opioids market expected to grow? A: The global opioids market is expected to grow at a CAGR of 3.7% from 2023 to 2032, reaching USD 7.7 billion by 2032.

Q: What is the impact of regulatory changes on the codeine market? A: Regulatory changes, such as reclassifying codeine to prescription-only status, lead to increased regulatory compliance costs for the industry and higher costs for consumers, but also result in health gains and net financial savings.

Sources

  1. Coherent Market Insights: Codeine Market - Companies, Size, Share & Research Analysis.
  2. Therapeutic Goods Administration: Economic Modelling and Financial Quantification Regulatory Impact Proposed Changes Codeine Scheduling.
  3. United Nations Office on Drugs and Crime: DRUG MARKET TRENDS: CANNABIS OPIOIDS.
  4. The Brainy Insights: Opioids Market Size, Share | CAGR of 3.7%.
  5. United States Government Accountability Office: DRUG INDUSTRY: Profits, Research and Development Spending, and Merger and Acquisition Deals.

More… ↓

⤷  Subscribe

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.