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Last Updated: December 22, 2024

ACETAMINOPHEN AND CODEINE PHOSPHATE Drug Patent Profile


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Which patents cover Acetaminophen And Codeine Phosphate, and when can generic versions of Acetaminophen And Codeine Phosphate launch?

Acetaminophen And Codeine Phosphate is a drug marketed by Teva, Actavis Mid Atlantic, Chartwell, Chartwell Molecular, Dava Pharms Inc, Genus Lifesciences, Pai Holdings, Strides Pharma, Wockhardt Bio Ag, Able, Am Therap, Amneal Pharms Ny, Aurolife Pharma Llc, Duramed Pharms Barr, Elite Labs Inc, Everylife, Fosun Pharma, Halsey, Kv Pharm, Lederle, Mikart, Mutual Pharm, Nostrum Labs Inc, Puracap Pharm, Purepac Pharm, Rhodes Pharms, Roxane, Sandoz, Specgx Llc, Sun Pharm Inds Ltd, Superpharm, Usl Pharma, Valeant Pharm Intl, Vitarine, Warner Chilcott, Watson Labs, Watson Labs Florida, Wes Pharma Inc, and Whiteworth Town Plsn. and is included in eighty-nine NDAs.

The generic ingredient in ACETAMINOPHEN AND CODEINE PHOSPHATE is acetaminophen; codeine phosphate. There are sixty-six drug master file entries for this compound. Thirty suppliers are listed for this compound. Additional details are available on the acetaminophen; codeine phosphate profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Acetaminophen And Codeine Phosphate

A generic version of ACETAMINOPHEN AND CODEINE PHOSPHATE was approved as acetaminophen; codeine phosphate by WES PHARMA INC on June 27th, 2019.

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Summary for ACETAMINOPHEN AND CODEINE PHOSPHATE
Drug patent expirations by year for ACETAMINOPHEN AND CODEINE PHOSPHATE
Recent Clinical Trials for ACETAMINOPHEN AND CODEINE PHOSPHATE

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SponsorPhase
Roxane LaboratoriesPhase 1

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Pharmacology for ACETAMINOPHEN AND CODEINE PHOSPHATE
Drug ClassOpioid Agonist
Mechanism of ActionFull Opioid Agonists

US Patents and Regulatory Information for ACETAMINOPHEN AND CODEINE PHOSPHATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sandoz ACETAMINOPHEN AND CODEINE PHOSPHATE acetaminophen; codeine phosphate TABLET;ORAL 085917-001 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Wes Pharma Inc ACETAMINOPHEN AND CODEINE PHOSPHATE acetaminophen; codeine phosphate TABLET;ORAL 211610-001 Jun 27, 2019 AA RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Halsey ACETAMINOPHEN AND CODEINE PHOSPHATE acetaminophen; codeine phosphate TABLET;ORAL 086549-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Duramed Pharms Barr ACETAMINOPHEN AND CODEINE PHOSPHATE acetaminophen; codeine phosphate TABLET;ORAL 088355-001 Feb 6, 1984 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Superpharm ACETAMINOPHEN AND CODEINE PHOSPHATE acetaminophen; codeine phosphate TABLET;ORAL 089185-001 Oct 18, 1985 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Mikart ACETAMINOPHEN AND CODEINE PHOSPHATE acetaminophen; codeine phosphate TABLET;ORAL 089231-001 Mar 3, 1986 DISCN 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

ACETAMINOPHEN AND CODEINE PHOSPHATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Acetaminophen and Codeine Phosphate

Introduction

Acetaminophen and codeine phosphate is a combination drug used to treat mild to moderate pain, cough, and sometimes diarrhea. This article delves into the market dynamics and financial trajectory of this drug, highlighting key factors influencing its demand and market value.

Market Overview

The global analgesics market, within which acetaminophen and codeine phosphate operates, is substantial. Here are some key points:

  • Global Analgesics Market: The global analgesics market was valued at approximately USD 109.9 billion in 2022, with acetaminophen drugs accounting for about 8.9% of this total[3].

Acetaminophen Market Trends

The acetaminophen market, a significant component of the analgesics market, is growing steadily.

  • Market Value and Growth: The global acetaminophen market was valued at USD 9.8 billion in 2022 and is expected to grow at a Compound Annual Growth Rate (CAGR) of 4.2% to reach USD 15.2 billion by 2033[3].

  • Route of Administration: The oral route of administration dominates the market, accounting for about 92.4% of the market share in 2022[3].

Drivers of Demand

Several factors are driving the demand for acetaminophen and codeine phosphate:

  • Chronic Illnesses: The increasing prevalence of chronic illnesses such as cancer, chronic obstructive pulmonary disease (COPD), and other conditions requiring ongoing pain management is a significant driver[3].

  • Opioid Tolerance: The rising issue of opioid tolerance and the need for alternative pain management options are also boosting demand for acetaminophen-based medications[3].

  • Safety and Efficacy: Acetaminophen is often preferred due to its safety profile, especially in comparison to opioids, and its widespread availability across all age groups, including infants and children[3].

Regional Market Dynamics

The demand for acetaminophen and codeine phosphate varies by region:

  • North America and Europe: These regions hold a significant market share due to the drug's superior efficacy and widespread availability. The acetaminophen segment is expected to maintain the largest market share of approximately 62.1% in these regions[3].

  • Asia-Pacific: Countries like India and China are driving growth in the Asia-Pacific region. India holds about 45.5% of the South Asia market and is projected to display lucrative growth during the forecast period. China is set to exhibit growth at a CAGR of nearly 5.3% due to an aging population and increasing life expectancy[3].

Competitive Landscape

The market for acetaminophen and codeine phosphate is competitive, with several key players:

  • Major Players: Companies such as Pfizer Inc., Sanofi, Janssen Pharmaceuticals, Bayer AG, GlaxoSmithKline plc, and others are prominent in the market[3].

Regulatory and Safety Considerations

The use of acetaminophen and codeine phosphate is subject to various regulatory and safety considerations:

  • Respiratory Depression: The combination can cause serious or life-threatening breathing problems, especially in children and individuals with certain health conditions. This has led to strict guidelines and warnings, particularly for pediatric patients[2][5].

  • Cytochrome P450 Interactions: The drug's metabolism is affected by interactions with cytochrome P450 3A4 and 2D6 inhibitors or inducers, which can alter its efficacy and safety profile[1].

Financial Trajectory

The financial trajectory of acetaminophen and codeine phosphate is closely tied to the broader analgesics market and the specific trends within the acetaminophen segment.

  • Market Expansion: The expected growth of the acetaminophen market at a CAGR of 4.2% from 2023 to 2033 indicates a positive financial trajectory for this drug combination[3].

  • Revenue Projections: With the global acetaminophen market projected to reach USD 15.2 billion by 2033, companies involved in the production and distribution of acetaminophen and codeine phosphate can anticipate significant revenue growth[3].

Challenges and Opportunities

Despite the positive outlook, there are challenges and opportunities to consider:

  • Challenges: The risk of respiratory depression, especially in vulnerable populations, and the need for careful management of cytochrome P450 interactions are significant challenges. Additionally, the ongoing opioid crisis and regulatory scrutiny can impact market dynamics[1][2][5].

  • Opportunities: The growing demand for opioid-tolerant pharmaceuticals and the need for effective pain management solutions present opportunities for innovation and market expansion. The commercialization of opioid-tolerant medications could be a key area of growth[3].

Key Takeaways

  • The global acetaminophen market is growing at a CAGR of 4.2%, driven by increasing chronic illnesses and the need for safe pain management options.
  • The Asia-Pacific region, particularly India and China, is a significant growth area due to demographic changes and increasing life expectancy.
  • Regulatory and safety considerations, such as the risk of respiratory depression, are crucial and must be carefully managed.
  • The competitive landscape is dominated by major pharmaceutical companies, and the market is expected to continue growing due to the drug's efficacy and safety profile.

Frequently Asked Questions (FAQs)

Q: What are the primary uses of acetaminophen and codeine phosphate? A: Acetaminophen and codeine phosphate are used to treat mild to moderate pain, cough, and sometimes diarrhea.

Q: Why is the acetaminophen market growing? A: The market is growing due to the increasing prevalence of chronic illnesses, the need for safe pain management options, and the rising issue of opioid tolerance.

Q: What are the key regions driving the growth of the acetaminophen market? A: North America, Europe, India, and China are the key regions driving the growth of the acetaminophen market.

Q: What are the safety concerns associated with acetaminophen and codeine phosphate? A: The combination can cause serious or life-threatening breathing problems, especially in children and individuals with certain health conditions. Cytochrome P450 interactions also need careful management.

Q: Who are the major players in the acetaminophen market? A: Major players include Pfizer Inc., Sanofi, Janssen Pharmaceuticals, Bayer AG, GlaxoSmithKline plc, and others.

Sources:

  1. Acetaminophen and Codeine Phosphate Tablets USP - Mallinckrodt Pharmaceuticals.
  2. Codeine - Wikipedia.
  3. Acetaminophen Market Size, Share, Trends & Outlook - Future Market Insights.
  4. IQVIA Report on Stimulant Trends from 2012-2022 - U.S. Department of Justice.
  5. Acetaminophen and Codeine: MedlinePlus Drug Information - MedlinePlus.

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