ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE - Generic Drug Details

What are the generic drug sources for acetaminophen; oxycodone hydrochloride and what is the scope of freedom to operate?

Acetaminophen; oxycodone hydrochloride is the generic ingredient in twelve branded drugs marketed by Actavis Elizabeth, Barr, Duramed Pharms Barr, Halsey, Mallinckrodt, Mutual Pharm, Vintage Pharms, Vintage Pharms Llc, Watson Labs, Roxane, Janssen Pharms, Ortho Mcneil Pharm, Abhai Llc, Mikart, Sankalp Lifecare, Specgx Llc, Ph Health, Hikma, Mallinckrodt Inc, Bristol Myers Squibb, Alvogen, Amneal Pharms, Amneal Pharms Ny, Ascent Pharms Inc, Aurolife Pharma Llc, Chartwell, Dr Reddys Labs Sa, Elite Labs Inc, Epic Pharma Llc, Granules, Lannett Co Inc, Nesher Pharms, Novel Labs Inc, Rhodes Pharms, Sanaluz, Sun Pharm Inds Inc, Wes Pharma Inc, and Endo Operations, and is included in sixty-six NDAs. There are twelve patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Acetaminophen; oxycodone hydrochloride has thirty-one patent family members in thirteen countries.

Thirty-four suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

International Patents:	31
US Patents:	12
Tradenames:	12
Applicants:	38
NDAs:	66
Finished Product Suppliers / Packagers:	34
Raw Ingredient (Bulk) Api Vendors:	4
Clinical Trials:	156
Patent Applications:	183
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
DailyMed Link:	ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE at DailyMed

Recent Clinical Trials for ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

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

Sponsor	Phase
Second Affiliated Hospital, School of Medicine, Zhejiang University	NA
Texas Scottish Rite Hospital for Children	PHASE2
University of North Carolina, Chapel Hill	PHASE4

See all ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE clinical trials

Generic filers with tentative approvals for ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

Applicant	Application No.	Strength	Dosage Form
		325MG; 7.5MG	TABLET, EXTENDED RELEASE;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

Drug Class	Opioid Agonist
Mechanism of Action	Full Opioid Agonists

Anatomical Therapeutic Chemical (ATC) Classes for ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

N02AA	Natural opium alkaloids
N02A	OPIOIDS
N02	ANALGESICS
N	Nervous system

US Patents and Regulatory Information for ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Chartwell	OXYCODONE AND ACETAMINOPHEN	acetaminophen; oxycodone hydrochloride	TABLET;ORAL	207834-001	Aug 15, 2019		DISCN	No	No
Aurolife Pharma Llc	OXYCODONE AND ACETAMINOPHEN	acetaminophen; oxycodone hydrochloride	TABLET;ORAL	201972-003	Jul 15, 2013	AA	RX	No	No
Watson Labs	OXYCODONE AND ACETAMINOPHEN	acetaminophen; oxycodone hydrochloride	TABLET;ORAL	040371-002	Dec 29, 2000		DISCN	No	No

Expired US Patents for ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Mallinckrodt Inc	XARTEMIS XR	acetaminophen; oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	204031-001	Mar 11, 2014	6,488,962

International Patents for ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

Country	Patent Number	Title	Estimated Expiration
South Korea	20140021992	METHODS OF PRODUCING STABILIZED SOLID DOSAGE PHARMACEUTICAL COMPOSITIONS CONTAINING MORPHINANS
Japan	2015193668	モルフィナンを含む安定した固体剤形の薬学的組成物を生成する方法 (METHODS OF PRODUCING STABILIZED SOLID DOSAGE PHARMACEUTICAL COMPOSITIONS CONTAINING MORPHINANS)
European Patent Office	2262484

Market Dynamics and Financial Trajectory for the Pharmaceutical Drugs: Acetaminophen and Oxycodone Hydrochloride

Last updated: July 29, 2025

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Introduction

The landscape of pharmaceutical therapeutics for pain management and fever reduction encompasses a broad spectrum, with acetaminophen (paracetamol) and oxycodone hydrochloride occupying pivotal yet contrasting roles. Their respective market dynamics and financial trajectories reveal insights rooted in regulatory shifts, consumer demand, health policy reforms, and evolving medical standards. Examining these two drugs offers a comprehensive understanding of the foundational shifts shaping pain medication markets globally.

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Acetaminophen: Market Position and Financial Outlook

Market Overview

Acetaminophen, a widely used analgesic and antipyretic, commands a dominant position in over-the-counter (OTC) pain management therapies. Its extensive integration into consumer healthcare products—ranging from single-ingredient formulations to combination medications—cements its status as a staple medical commodity.

Demand Drivers

The consistent demand for acetaminophen stems from its safety profile relative to opioids, affordability, and public health campaigns advocating non-opioid pain treatments. Its role in managing mild to moderate pain and fever makes it a preferred OTC option, especially amid initiatives to curb opioid misuse.

Regulatory and Public Health Impact

Regulatory authorities such as the U.S. Food and Drug Administration (FDA) have implemented dosing limits and public awareness campaigns to prevent hepatotoxicity associated with overdose. These safety measures influence market stability by maintaining consumer trust while constraining the supply chain flexibility somewhat.

Market Trends

Emerging formulations, including extended-release and combination drugs, broaden its market penetration. Moreover, countries with expanding healthcare infrastructure, particularly in Asia and Africa, are witnessing increased acetaminophen consumption.

Financial Trajectory

Anticipated growth remains steady, with projections estimating a compound annual growth rate (CAGR) of approximately 3-5% over the next five years. The OTC segment's resilience, combined with ongoing product innovation, sustains revenue streams for both generic and branded manufacturers.

Digital health initiatives and e-commerce channels further facilitate distribution, potentially expanding reach. However, regulatory scrutiny regarding hepatotoxicity risks and the introduction of new safety standards could modulate growth trajectories.

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Oxycodone Hydrochloride: Market Dynamics and Challenges

Market Overview

Oxycodone hydrochloride, a potent opioid analgesic, occupies a complex niche within pain management, predominantly in prescription formulations for moderate to severe pain. Its mechanism as a mu-opioid receptor agonist underpins its efficacy but also underscores the risks associated with misuse, addiction, and overdose.

Demand Drivers

The global opioid market is driven by an aging population with chronic pain conditions, advancements in pain management protocols, and increasing acceptance of opioid therapy. Oxycodone remains a frontline treatment in severe pain scenarios, with formulations like controlled-release and combination products (e.g., with acetaminophen or naloxone).

Regulatory and Sociopolitical Factors

Stringent regulatory frameworks—such as prescription drug monitoring programs, abuse-deterrent formulations, and tighter prescribing guidelines—have significantly impacted availability. The rise in opioid misuse and associated mortality has led to regulatory crackdowns, impacting market volume.

Legislative actions have also catalyzed a shift toward alternative therapies, thus constraining the growth of oxycodone sales in certain jurisdictions and prompting manufacturers to innovate with abuse-deterrent formulations.

Market Trends

The opioid crisis has instigated a tectonic shift from prescription opioids to non-addictive pain management options. In parallel, there is increasing emphasis on convergence between pharmaceutical innovation and public health priorities, including the development of overdose reversal agents such as naloxone and novel non-opioid analgesics.

Financial Trajectory

The financial trajectory for oxycodone is fraught with challenges. Revenues have plateaued or declined in markets with aggressive regulatory standpoints and public health setbacks. For example, the U.S. market, historically the largest, experienced a marked decline in oxycodone prescriptions after 2017 due to policy interventions, with estimated CAGR dropping to negative values depending on the timeframe.

In emerging markets, increased access and healthcare reforms may offer opportunities; however, the overall financial outlook remains constrained by legal risks, reimbursement uncertainties, and the societal shift toward non-opioid alternatives.

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Comparative Analysis: Contrasting Market Dynamics

Aspect	Acetaminophen	Oxycodone Hydrochloride
Market Penetration	Extensive OTC use, global presence	Prescription-only, regulated, declining in some regions
Regulatory Environment	Focused on overdose prevention	Emphasis on abuse deterrence, prescribing limits
Consumer Demand	Steady, driven by safety and affordability	Fluctuating, influenced by regulatory shifts and societal attitudes
Innovation	Formulation improvements, combination products	Abuse-deterrent formulations, novel delivery systems
Financial Stability	Consistent growth, resilient	Volatile, declining in mature markets

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Implications for Stakeholders

Pharmaceutical Companies

Companies focusing on acetaminophen will benefit from stable demand and product innovation tailored toward safety enhancements. Conversely, those invested in oxycodone face increasing regulatory hurdles, necessitating diversification into non-opioid analgesics or abuse-resistant formulations.

Investors

Financial prospects favor acetaminophen-based product lines, aligned with public health trends reducing opioid reliance. Investments in opioid markets now demand careful risk assessment, with particular attention to legal liabilities and market stability.

Regulators and Policymakers

Regulatory frameworks must balance pain management needs against addiction risks. Policies that incentivize safe prescribing, promote alternative therapies, and foster innovation in non-addictive analgesics will shape future market dynamics.

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Future Outlook and Trends

The global pain management market is expected to evolve with a growing emphasis on personalized medicine, multi-modal pain management protocols, and non-addictive alternatives, likely reducing dependence on opioids like oxycodone. Meanwhile, the steady, albeit cautious, growth of acetaminophen underscores its enduring relevance.

Emerging markets represent a fertile ground for acetaminophen expansion, especially with rising healthcare access. Conversely, oxycodone’s market landscape will continue to shrink or transform, with legal and societal pressures steering its decline or reformulation.

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Key Takeaways

• Growth Stability: Acetaminophen is projected to sustain modest CAGR of 3-5%, supported by OTC demand, product innovation, and expanding markets in emerging economies.
• Regulatory Impact: Stringent regulations curbing oxycodone use are plateauing or reducing its market size, especially in developed nations with robust abuse mitigation policies.
• Innovation Focus: Both segments are fostering formulation innovations—acetaminophen with safety features; oxycodone with abuse-deterrent systems—to address safety concerns.
• Market Shift: Societal push to combat opioid misuse accelerates a shift towards non-addictive therapies, reconfiguring the analgesic landscape.
• Investment Strategy: Stakeholders should prioritize acetaminophen and non-opioid analgesics for growth opportunities while managing risks associated with oxycodone.

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FAQs

1. How are regulatory changes impacting the acetaminophen market?
Regulatory agencies have implemented safety measures like dosage limits and warning labels to mitigate overdose risks, which influence manufacturing practices but have not significantly curtailed overall demand due to the drug’s essential status in pain management and fever reduction.

2. What are the primary concerns surrounding oxycodone hydrochloride?
The key issues are addiction potential, overdose risk, and societal health impacts, prompting tighter prescribing guidelines, abuse-deterrent formulations, and increased regulatory oversight.

3. Are there emerging alternatives to oxycodone that could influence its market?
Yes. Development of non-opioid analgesics, such as nerve growth factor inhibitors, cannabinoid-based therapies, and multi-modal pain strategies, threaten oxycodone’s dominance and could reshape pain management protocols.

4. What role does innovation play in the future of acetaminophen?
Innovation aims to enhance safety, such as tamper-resistant formulations and combination products that reduce overdose risk, ensuring continued consumer trust and market share.

5. Can emerging markets offset declines in developed regions for these drugs?
Emerging markets present growth opportunities due to increased healthcare infrastructure and demand; however, regulatory environments and economic factors will determine the extent of this potential.

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References

[1] U.S. Food and Drug Administration. (2022). Acetaminophen Usage and Safety. FDA.gov.
[2] IMS Health. (2021). Global Pain Management Market Report.
[3] Centers for Disease Control and Prevention. (2022). Opioid Overdose Prevention. CDC.gov.
[4] MarketWatch. (2023). The Future of Non-Opioid Painkillers.
[5] WHO. (2020). Essential Medicines List: Acetaminophen and Opioids.

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In conclusion, understanding the contrasting market dynamics and financial trajectories of acetaminophen and oxycodone hydrochloride provides strategic insights important for pharmaceutical stakeholders. As public health priorities shift and regulations tighten, the industry must innovate and adapt to sustain growth and meet evolving demands efficiently.