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, Pharmobedient, Strides Pharma, Valeant Pharms Llc, Able, Am Therap, Amneal Pharms Ny, Ani Pharms, Aurolife Pharma Llc, Duramed Pharms Barr, Elite Labs Inc, Everylife, Fosun Pharma, Halsey, Hibrow Hlthcare, Kv Pharm, Lederle, Mikart, Mutual Pharm, Puracap Pharm, Purepac Pharm, Rhodes Pharms, Roxane, Sandoz, Specgx Llc, Strides Pharma Intl, Sun Pharm Inds Ltd, Superpharm, Usl Pharma, Valeant Pharm Intl, Vitarine, Warner Chilcott, Watson Labs, Watson Labs Florida, 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.

Twenty-nine suppliers are listed for this compound.

Summary for acetaminophen; codeine phosphate

US Patents:	0
Tradenames:	17
Applicants:	48
NDAs:	108
Finished Product Suppliers / Packagers:	29
Raw Ingredient (Bulk) Api Vendors:	2
Clinical Trials:	1
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
Valeant Pharms Llc	CAPITAL AND CODEINE	acetaminophen; codeine phosphate	SUSPENSION;ORAL	086024-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Watson Labs	ACETAMINOPHEN AND CODEINE PHOSPHATE	acetaminophen; codeine phosphate	TABLET;ORAL	087275-001	May 26, 1982		DISCN	No	No
Vangard	PAPA-DEINE #3	acetaminophen; codeine phosphate	TABLET;ORAL	088037-001	Mar 20, 1984		DISCN	No	No
Sandoz	ACETAMINOPHEN AND CODEINE PHOSPHATE	acetaminophen; codeine phosphate	TABLET;ORAL	087423-001	Approved Prior to Jan 1, 1982		DISCN	No	No

Market Dynamics and Financial Trajectory for Acetaminophen; Codeine Phosphate

Last updated: July 29, 2025

Introduction

Acetaminophen combined with codeine phosphate remains a cornerstone in analgesic therapy, particularly for moderate to severe pain management. Its long-standing clinical utility, combined with evolving regulatory landscapes and market forces, shapes its economic and strategic significance. This analysis delineates the market dynamics and forecasts the financial trajectory of this combination drug, considering factors like regulatory challenges, manufacturing trends, demand shifts, and emerging therapeutics.

Overview of Acetaminophen; Codeine Phosphate

The combination of acetaminophen (paracetamol) and codeine phosphate synthesizes two analgesic agents: acetaminophen offers analgesic and antipyretic effects, while codeine, an opioid, enhances pain relief. Approved globally, particularly in the United States and Europe, it caters to prescriptions for pain that require moderate to severe management.

However, due to concerns regarding opioid misuse and regulatory restrictions, the biodegradable lifecycle of this drug faces notable headwinds, influencing its market volume and revenue streams.

Market Dynamics

Demand Drivers

1. Clinical Efficacy and Prescribing Patterns:
Despite the advent of novel analgesics, the acetaminophen-codeine formulation retains popularity due to its established efficacy, safety profile in appropriate doses, and affordability. It predominantly serves hospitals, primary care, and pain clinics, especially where ease of access and familiarity influence prescribing.

2. Pain Management Needs:
Global aging populations and the rising prevalence of chronic pain conditions bolster demand. In regions with limited access to alternative therapies, this combination remains a frontline option.

3. Regulatory Acceptance:
Certain jurisdictions continue to permit use under tightly controlled circumstances. The drug’s inclusion in formularies and insurance coverages sustains demand, although this is increasingly challenged by opioid regulation policies.

Supply-Side Constraints

1. Manufacturing and Supply Chain:
The production depends on sourcing pharmaceutical-grade acetaminophen and pharmaceutical-grade codeine. Regulatory oversight, such as DEA scheduling in the U.S., limits raw material availability, potentially constraining supply.

2. Regulatory and Legal Challenges:
Stringent regulations, driven by the opioid epidemic, have led many countries to impose severe restrictions on codeine. For instance, the UK reclassified codeine-containing products as pharmacy-only medicines, reducing dependence on doctor prescriptions and impacting sales volumes.

3. Patents and Generic Competition:
While patent protections for combination formulations have long expired, regulatory barriers often delay generic entry, impacting pricing strategies. Conversely, increased generic competition in mature markets has exerted downward pressure on prices and profit margins.

Regulatory and Ethical Considerations

The global trend of opioid regulation heightens scrutiny over codeine-containing drugs. Governments enforce stricter prescription monitoring programs and impose dosage restrictions to curb misuse, which may suppress demand or shift the market towards alternative therapies.

Emerging Competitive Alternatives

Newer analgesic agents, non-opioid combinations, and patient-controlled analgesia systems threaten the market share of acetaminophen-codeine. Additionally, opioid-sparing approaches, including nerve blocks or non-pharmacologic therapies, influence prescribing patterns.

Financial Trajectory

Historical Performance

In developed markets, the revenue from acetaminophen; codeine phosphate formulations peaked during the early 2010s but has since plateaued. For example, in the U.S., sales have declined modestly due to regulatory restrictions, with the market transitioning towards alternative pain management options.

Forecasting Future Revenue

1. Short-to-Medium Term (Next 5 Years):
Given the tightening regulations and the opioid crisis, revenues are projected to decline at a compound annual growth rate (CAGR) of approximately 2-4%. In mature markets like North America and Europe, the decline could accelerate to 5% annually, driven by strict prescribing limits and widespread dissemination of alternative therapies.

2. Long-Term Outlook (Beyond 5 Years):
The combination’s market value will depend on regulatory trajectories, clinical guidelines, and emergence of novel treatments. If restrictions tighten further, especially concerning codeine, the global market could shrink by 20-30%, with some regions potentially phasing out use altogether.

3. Emerging Markets:
In regions such as Asia-Pacific and Latin America, where regulatory frameworks may be less restrictive, the drug could see modest growth, driven by increasing healthcare infrastructure and rising pain management needs. However, this potential is tempered by the global movement toward opioid reduction.

Price Trends

Pricing pressure, due to generic competition and policy constraints, is expected to sustain low or declining prices. Nonetheless, brand-name formulations could maintain premium pricing in markets with limited generics.

Factors Influencing the Financial Outlook

• Regulatory Environment: Critical determinant; increasing restrictions reduce market size.
• Public Health Policy: The broader effort to combat opioid misuse curtails usage.
• Patent and Market Exclusivity: Limited patent life leads to generic infiltration, depressing prices and profits.
• Innovation: Lack of new formulations or improved delivery systems diminishes revenue prospects.
• Alternative Therapies: Growing preference for non-opioid analgesics and non-pharmacologic options reduce reliance on this combination.

Strategic Implications

Manufacturers must adapt by diversifying portfolios, investing in non-opioid analgesic development, or repositioning existing formulations within compliant therapeutic frameworks. Companies with established distribution networks and extensive product pipelines may leverage their positions to navigate the declining trajectory.

Key Takeaways

• The market for acetaminophen; codeine phosphate is experiencing a contraction driven by regulatory restrictions, public health initiatives, and evolving prescribing practices.
• Demand remains stable in certain regions, particularly where access to alternatives is limited; however, global trends favor opioid reduction.
• Revenue forecasts indicate a modest decline in the next five years, with more significant reductions projected long-term in developed countries.
• Market competition from generics and alternative therapies will exert downward pressure on prices and margins.
• For sustained viability, companies should innovate or diversify into non-opioid pain management solutions, aligning with evolving global health policies.

FAQs

1. How have regulatory changes impacted the global market for acetaminophen; codeine phosphate?
Regulatory actions, especially in North America and Europe, have imposed tighter controls on codeine sales, reducing demand and access. These measures have contributed to declining sales volumes and shifting prescribing patterns toward non-opioid options.

2. What are the primary challenges facing manufacturers of this combination drug?
Key challenges include regulatory restrictions limiting opioid use, increasing generic competition pressuring margins, reduced market share in mature markets, and the need to adapt to non-opioid pain management trends.

3. Are there emerging therapeutic alternatives threatening this drug’s market?
Yes. Non-opioid analgesic formulations, nerve blocks, physical therapy, and digital health platforms provide alternative pain management strategies, reducing reliance on acetaminophen; codeine combinations.

4. What geographic regions present growth opportunities despite the global decline?
Emerging markets such as Asia-Pacific and parts of Latin America still exhibit demand due to limited access to newer therapies and regulatory laxity but are also subject to tightening controls over time.

5. How should pharmaceutical companies position themselves for the future of pain management?
Companies should invest in research and development of non-opioid analgesics, explore novel delivery systems, and engage with evolving regulatory environments to adapt their portfolios accordingly.

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References

1. U.S. Food and Drug Administration. "FDA updates on opioid regulation." (2022).
2. World Health Organization. "Guidelines for pain management." (2020).
3. IQVIA. "Global analgesic market analysis." (2021).
4. European Medicines Agency. "Regulatory policies on opioids." (2022).
5. MarketWatch. "Pain management drugs market outlook." (2022).