ACETAMINOPHEN; CODEINE PHOSPHATE - Generic Drug Details

What are the generic sources for acetaminophen; codeine phosphate and what is the scope of patent protection?

Acetaminophen; codeine phosphate is the generic ingredient in seventeen branded drugs marketed by Teva, Robins Ah, Solvay, Ortho Mcneil Pharm, Actavis Mid Atlantic, Chartwell, Chartwell Molecular, Dava Pharms Inc, Genus Lifesciences, Pai Holdings, Strides Pharma, Wockhardt Bio Ag, Valeant Pharms Llc, 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, Whiteworth Town Plsn, Carnrick, Glaxosmithkline, Vangard, and Janssen Pharms, and is included in one hundred and eight NDAs. Additional information is available in the individual branded drug profile pages.

Thirty suppliers are listed for this compound.

Summary for ACETAMINOPHEN; CODEINE PHOSPHATE

US Patents:	0
Tradenames:	17
Applicants:	47
NDAs:	108
Finished Product Suppliers / Packagers:	30
Raw Ingredient (Bulk) Api Vendors:	2
Clinical Trials:	1
Patent Applications:	501
DailyMed Link:	ACETAMINOPHEN; CODEINE PHOSPHATE at DailyMed

Recent Clinical Trials for ACETAMINOPHEN; CODEINE PHOSPHATE

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

Sponsor	Phase
Roxane Laboratories	Phase 1

See all ACETAMINOPHEN; CODEINE PHOSPHATE clinical trials

Pharmacology for ACETAMINOPHEN; CODEINE PHOSPHATE

Drug Class	Opioid Agonist
Mechanism of Action	Full Opioid Agonists

Anatomical Therapeutic Chemical (ATC) Classes for ACETAMINOPHEN; CODEINE PHOSPHATE

R05DA	Opium alkaloids and derivatives
R05D	COUGH SUPPRESSANTS, EXCL. COMBINATIONS WITH EXPECTORANTS
R05	COUGH AND COLD PREPARATIONS
R	Respiratory system

US Patents and Regulatory Information for ACETAMINOPHEN; CODEINE PHOSPHATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ortho Mcneil Pharm	TYLENOL W/ CODEINE	acetaminophen; codeine phosphate	TABLET;ORAL	085056-002	Approved Prior to Jan 1, 1982		DISCN	No	No
Pai Holdings	ACETAMINOPHEN AND CODEINE PHOSPHATE	acetaminophen; codeine phosphate	SOLUTION;ORAL	040119-001	Apr 26, 1996		DISCN	No	No
Warner Chilcott	ACETAMINOPHEN AND CODEINE PHOSPHATE	acetaminophen; codeine phosphate	TABLET;ORAL	085218-002	Approved Prior to Jan 1, 1982		DISCN	No	No

ACETAMINOPHEN; CODEINE PHOSPHATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Acetaminophen and Codeine Phosphate

Introduction

Acetaminophen and codeine phosphate, a combination of an opioid analgesic and a non-opioid analgesic, is widely used for managing mild to moderate pain. This article delves into the market dynamics, financial trajectory, and key factors influencing the demand and supply of this medication.

Medical Uses and Indications

Acetaminophen and codeine phosphate is indicated for the management of mild to moderate pain, where treatment with an opioid is appropriate and alternative treatments are inadequate. It is commonly used for post-surgical dental pain, cancer pain, and to relieve coughing and diarrhea[2][4].

Market Size and Growth

The market for codeine phosphate, including its combination with acetaminophen, is experiencing moderate growth. The codeine phosphate injection market, for instance, was valued at USD 14.53 million in 2023 and is projected to reach USD 15.08 million in 2024, with a forecasted increase to USD 21.24 million by 2032, exhibiting a CAGR of 3.8% during the forecast period[3].

Drivers of Market Growth

Several factors are driving the growth of the acetaminophen and codeine phosphate market:

Increasing Demand for Pain Management

The rising prevalence of chronic pain conditions, such as cancer and postoperative pain, has led to a growing need for effective pain management solutions. This trend is particularly evident in hospitals and outpatient settings where rapid pain relief is crucial for patient recovery and satisfaction[3].

Aging Population

The aging population is another significant driver, as older adults often experience chronic pain and require more substantial medical interventions. This demographic shift is expected to further fuel the demand for analgesic medications like acetaminophen and codeine phosphate[3].

Expansion of Healthcare Access

The expansion of healthcare access in developing regions is contributing to market growth. As more patients gain access to healthcare services, there is a corresponding increase in the demand for pain management solutions. Initiatives aimed at training healthcare professionals in the appropriate use of opioids also support this growth[3].

Regional Outlook

The market for acetaminophen and codeine phosphate exhibits diverse growth patterns across different regions:

North America

North America, particularly the United States, holds a dominant position in the market due to its advanced healthcare infrastructure and high prevalence of chronic pain conditions. However, the opioid epidemic has prompted regulatory scrutiny, leading to more stringent prescribing guidelines[3].

Asia-Pacific

The Asia-Pacific region is projected to witness the highest growth rate during the forecast period, driven by increasing healthcare expenditure, rising patient populations, and expanding access to advanced medical treatments. Countries like China and India are investing heavily in healthcare infrastructure, enhancing the availability of codeine phosphate injections and promoting market growth[3].

Financial Considerations

The financial trajectory of acetaminophen and codeine phosphate is influenced by several factors:

Pricing and Therapeutic Alternatives

CAPITAL® AND CODEINE ORAL SUSPENSION, for example, is at a significant price premium relative to its therapeutic alternatives such as generic Tylenol #3 Elixir and acetaminophen and codeine oral solution. This pricing dynamic can affect market share and revenue[5].

Investment Opportunities

The rising demand for effective pain management solutions presents investment opportunities in the research and development of innovative codeine phosphate formulations and delivery systems. Companies focusing on personalized medicine and patient-specific formulations can enhance treatment outcomes and differentiate themselves in a competitive market[3].

Regulatory Environment

The regulatory environment plays a crucial role in shaping the market dynamics:

Opioid Epidemic and Regulatory Scrutiny

The opioid epidemic has led to increased regulatory scrutiny, resulting in more stringent prescribing guidelines. This has impacted the market by reducing the number of prescriptions for opioids, including acetaminophen and codeine phosphate. However, the ongoing need for effective pain management ensures that these medications remain vital components of treatment protocols[3].

Safety and Efficacy Concerns

The FDA has issued warnings about the use of codeine in young patients, particularly after tonsillectomy, due to the risk of fatal respiratory depression. This has led to cautious use recommendations and heightened monitoring for signs of opioid toxicity and withdrawal[2].

Pharmacokinetics and Drug Interactions

Understanding the pharmacokinetics and potential drug interactions is crucial for safe and effective use:

Metabolism and Bioavailability

Codeine is metabolized in the liver by CYP2D6 to morphine and by CYP3A4 to norcodeine. The concomitant use of CYP3A4 inhibitors or inducers can significantly affect codeine plasma concentrations and the levels of its active metabolite, morphine, potentially leading to increased adverse reactions or reduced efficacy[1][2].

Key Takeaways

• The market for acetaminophen and codeine phosphate is driven by increasing demand for pain management solutions, an aging population, and the expansion of healthcare access.
• North America dominates the market, but the Asia-Pacific region is expected to show the highest growth rate.
• Regulatory scrutiny due to the opioid epidemic has led to more stringent prescribing guidelines.
• Investment opportunities exist in the development of innovative formulations and personalized medicine.
• Pharmacokinetic interactions and safety concerns must be carefully managed to ensure safe and effective use.

FAQs

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

Q: What is the projected market growth for codeine phosphate injections? A: The codeine phosphate injection market is projected to grow from USD 14.53 million in 2023 to USD 21.24 million by 2032, with a CAGR of 3.8%.

Q: How does the regulatory environment impact the market for acetaminophen and codeine phosphate? A: The opioid epidemic has led to increased regulatory scrutiny, resulting in more stringent prescribing guidelines, which can affect market share and revenue.

Q: What are the potential drug interactions to consider when using acetaminophen and codeine phosphate? A: Concomitant use with CYP3A4 inhibitors or inducers can significantly affect codeine plasma concentrations and the levels of its active metabolite, morphine.

Q: Are there any specific safety concerns associated with the use of acetaminophen and codeine phosphate? A: Yes, there are risks of respiratory depression, especially in young patients, and the potential for opioid addiction, abuse, and misuse.

Cited Sources:

1. Acetaminophen and Codeine Phosphate Tablets USP - Mallinckrodt Pharmaceuticals.
2. Codeine - Wikipedia.
3. Codeine Phosphate Injection Market Share, Forecast [2024-2032] - Global Growth Insights.
4. ACETAMINOPHEN AND CODEINE PHOSPHATE solution - DailyMed.
5. Capital and Codeine / Minnesota Department of Human Services - Minnesota Department of Human Services.