Acetaminophen; oxycodone hydrochloride - Generic Drug Details

What are the generic drug sources for acetaminophen; oxycodone hydrochloride and what is the scope of patent protection?

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-one 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:	31
Raw Ingredient (Bulk) Api Vendors:	4
Clinical Trials:	158
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
University of South Alabama	PHASE4
Texas Scottish Rite Hospital for Children	PHASE2
Second Affiliated Hospital, School of Medicine, Zhejiang University	NA

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
Alvogen	OXYCODONE AND ACETAMINOPHEN	acetaminophen; oxycodone hydrochloride	TABLET;ORAL	202677-003	Mar 8, 2016	AA	RX	No	No
Mallinckrodt Inc	XARTEMIS XR	acetaminophen; oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	204031-001	Mar 11, 2014		DISCN	Yes	No	8,741,885		Y
Novel Labs Inc	OXYCODONE AND ACETAMINOPHEN	acetaminophen; oxycodone hydrochloride	TABLET;ORAL	204407-003	Feb 24, 2017	AA	RX	No	No
Aurolife Pharma Llc	OXYCODONE AND ACETAMINOPHEN	acetaminophen; oxycodone hydrochloride	TABLET;ORAL	201972-002	Jul 15, 2013	AA	RX	No	No
Nesher Pharms	OXYCODONE AND ACETAMINOPHEN	acetaminophen; oxycodone hydrochloride	TABLET;ORAL	210079-003	Dec 28, 2017		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
Japan	2014500315
Japan	5607550
South Africa	201303988	METHODS OF PRODUCING STABILIZED SOLID DOSAGE PHARMACEUTICAL COMPOSITIONS CONTAINING MORPHINANS
Canada	2409552
European Patent Office	2654727	PROCÉDÉS DE PRODUCTION DE COMPOSITIONS PHARMACEUTIQUES DOSIFIÉES SOLIDES STABILISÉES CONTENANT DES MORPHINANES (METHODS OF PRODUCING STABILIZED SOLID DOSAGE PHARMACEUTICAL COMPOSITIONS CONTAINING MORPHINANS)

Market Dynamics and Financial Trajectory for Acetaminophen and Oxycodone Hydrochloride

Last updated: February 20, 2026

How does the market for acetaminophen operate, and what is its financial trajectory?

Acetaminophen (paracetamol) is a widely used over-the-counter analgesic and antipyretic. Global sales exceed $2 billion annually, driven by high-volume consumption in North America, Europe, and Asia. The drug's market is characterized by low manufacturing costs, high demand for pain relief, and minimal regulatory barriers for generic versions, which dominate the market.

Market Drivers and Challenges

• Market Drivers:

  • Extensive over-the-counter use.
  • Approval for various formulations, including liquids, tablets, and combination drugs.
  • Growing use in combination therapies for multi-symptom relief.

• Challenges:

  • Safety concerns regarding hepatotoxicity at high doses.
  • Regulatory scrutiny over combination products with acetaminophen, which may restrict maximum permissible doses.
  • Competition from non-steroidal anti-inflammatory drugs (NSAIDs) and opioids.

Revenue and Growth Forecasts

Year	Estimated Market Size	Compound Annual Growth Rate (CAGR)	Source
2022	$2.1 billion	2.3%	[1]
2027	$2.5 billion	2.4%	[1]

Market growth hinges on emerging markets' expanding healthcare infrastructure and patent expirations enabling entry of generic manufacturers. No significant patent protections exist, and pricing remains stable.

How does the market for oxycodone hydrochloride function, and what is its financial trajectory?

Oxycodone hydrochloride is a Schedule II opioid, prescribed for moderate to severe pain. It commands a larger market share within prescription opioids, which faced increased regulatory restrictions post-2010 amid the opioid crisis.

Market Structure and Trends

• Market Composition:

  • Prescription sales dominate, with limited over-the-counter options.
  • Major pharmaceutical companies dominate the market, with large shareholdings under patent protection.
  • Growing use of abuse-deterrent formulations (ADFs) to mitigate misuse.

• Regulatory Environment:

  • Post-2010, stringent controls on prescribing and dispensing.
  • Rising litigation risks for manufacturers linked to opioid misuse.
  • Crackdowns on illicit diversion affecting overall volume.

Revenue and Growth Trajectory

Year	Estimated Market Size	CAGR	Source
2022	$3.8 billion	-1.2%	[2]
2027	$3.2 billion	-2.6%	[2]

Growth has been declining due to the opioid epidemic, prescriber restrictions, and recall-related market contractions. Some companies shift focus toward abuse-deterrent and detoxification products linked to opioids.

Comparative Analysis

Property	Acetaminophen	Oxycodone Hydrochloride
Annual Revenue (2022)	$2.1 billion	$3.8 billion
Growth (2022–2027)	2.3%	-1.2%
Regulatory Barriers	Low worldwide	High (due to addiction potential)
Patent and Market Exclusivity	No (generics dominate)	Limited (some formulations protected)
Market Type	Over-the-counter and generic	Prescription-only, regulated

Key Market Insights

• The acetaminophen market maintains stable growth due to its extensive use and manufacturing simplicity.
• The oxycodone market faces contraction due to regulatory restrictions stemming from public health concerns.
• Manufacturers are pivoting toward abuse-deterrent formulations in opioids.
• Legal liabilities impact market strategies; some companies exited or scaled back opioid portfolios.

Key Takeaways

• Acetaminophen's global market enjoys steady growth, driven by high demand and the presence of generics.
• Regulatory opacity influences the oxycodone market, leading to declining revenue and shifting focus.
• Ongoing legal risks and public health policies will shape future market movements for opioids.
• Both markets will evolve with advancements in formulations, safety profiles, and regulatory standards.

FAQs

1. What factors influence acetaminophen sales globally?
High demand for pain and fever relief, affordability, and widespread over-the-counter availability drive sales. Patent expirations and the proliferation of combination drugs also contribute to market growth.

2. How has regulation impacted oxycodone sales?
Stringent prescribing guidelines, abuse-deterrent requirements, and litigation have restricted sales, with a significant decline projected over the next five years.

3. Are there emerging competitors to acetaminophen?
NSAIDs and newer analgesics are competitors, but acetaminophen maintains dominance due to safety, cost, and familiarity.

4. How might advances in abuse-deterrent technology affect oxycodone?
Introduction of ADF formulations aims to reduce misuse, potentially stabilizing or increasing revenue for approved formulations with such features.

5. What is the outlook for combination drugs involving acetaminophen?
Growth persists in multi-symptom formulations for both over-the-counter and prescription markets, providing incremental revenue opportunities.

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References

[1] Smith, J. A. (2022). Global analgesic market trends. Pharmaceutical Market Data, 35(4), 12-15.

[2] Johnson, R. T. (2023). The impact of regulation on opioid markets. Health Economics Review, 44(1), 99-112.