XARTEMIS XR Drug Patent Profile

Which patents cover Xartemis Xr, and what generic alternatives are available?

Xartemis Xr is a drug marketed by Mallinckrodt Inc and is included in one NDA. There are twelve patents protecting this drug.

This drug has thirty-one patent family members in thirteen countries.

The generic ingredient in XARTEMIS XR is acetaminophen; oxycodone hydrochloride. There are sixty-six drug master file entries for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the acetaminophen; oxycodone hydrochloride profile page.

DrugPatentWatch^® Generic Entry Outlook for Xartemis Xr

There have been three patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There is one tentative approval for the generic drug (acetaminophen; oxycodone hydrochloride), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for XARTEMIS XR

International Patents:	31
US Patents:	12
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	4
Clinical Trials:	2
Patent Applications:	109
Drug Prices:	Drug price information for XARTEMIS XR
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for XARTEMIS XR
DailyMed Link:	XARTEMIS XR at DailyMed

See drug prices for XARTEMIS XR

See drug sales revenues for XARTEMIS XR

Recent Clinical Trials for XARTEMIS XR

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

Sponsor	Phase
Mallinckrodt	Phase 4
Lotus Clinical Research, LLC	Phase 4

See all XARTEMIS XR clinical trials

US Patents and Regulatory Information for XARTEMIS XR

XARTEMIS XR is protected by twelve US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mallinckrodt Inc	XARTEMIS XR	acetaminophen; oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	204031-001	Mar 11, 2014		DISCN	Yes	No
Mallinckrodt Inc	XARTEMIS XR	acetaminophen; oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	204031-001	Mar 11, 2014		DISCN	Yes	No			Y
Mallinckrodt Inc	XARTEMIS XR	acetaminophen; oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	204031-001	Mar 11, 2014		DISCN	Yes	No
Mallinckrodt Inc	XARTEMIS XR	acetaminophen; oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	204031-001	Mar 11, 2014		DISCN	Yes	No			Y
Mallinckrodt Inc	XARTEMIS XR	acetaminophen; oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	204031-001	Mar 11, 2014		DISCN	Yes	No			Y
Mallinckrodt Inc	XARTEMIS XR	acetaminophen; oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	204031-001	Mar 11, 2014		DISCN	Yes	No			Y
Mallinckrodt Inc	XARTEMIS XR	acetaminophen; oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	204031-001	Mar 11, 2014		DISCN	Yes	No			Y

Expired US Patents for XARTEMIS XR

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

Premature patent expiration for: XARTEMIS XR

Expiration due to failure to pay maintenance fee

Patent Number	Tradename	Expiration Date
	XARTEMIS XR

International Patents for XARTEMIS XR

See the table below for patents covering XARTEMIS XR around the world.

Country	Patent Number	Title	Estimated Expiration
New Zealand	523214	A dosage form of a solid monolithic matrix non-circular in shape having first and second orthoganal axes of unequal length and that swells upon contact with water
Japan	2016166239	膨潤性の制御放出経口剤形の胃における滞留性を増強するための錠剤の形状 (TABLET SHAPE TO ENHANCE GASTRIC RETENTION OF SWELLABLE CONTROLLED-RELEASE ORAL DOSAGE FORM)
Japan	5607550
Denmark	1294363
European Patent Office	2262484	FORMES MÉDICAMENTEUSES À LIBÉRATION ÉTENDUE DE RÉTENTION GASTRIQUE COMPRENANT DES COMBINAISONS D'UN ANALGÉSIQUE NON OPIOÏDE ET D'UN ANALGÉSIQUE OPIOÏDE (GASTRIC RETENTIVE EXTENDED-RELEASE DOSAGE FORMS COMPRISING COMBINATIONS OF A NON-OPIOID ANALGESIC AND AN OPIOID ANALGESIC)
World Intellectual Property Organization (WIPO)	2012087377
Brazil	112013015622	métodos de produção de composições farmacêuticas de dosagem sólida estabilizadas contendo morfinanos

Market Dynamics and Financial Trajectory for XARTEMIS XR

Last updated: January 15, 2026

Executive Summary

XARTEMIS XR (extended-release combination of oxycodone and acetaminophen) is a prescription-only opioid analgesic targeting moderate to severe pain management. Launched by Mallinckrodt Pharmaceuticals, XARTEMIS XR gained approval from the U.S. Food and Drug Administration (FDA) in 2019. As a reformulation leveraging abuse-deterrent technology, its market trajectory is shaped by evolving regulatory environments, rising demand for opioid pain management, public health concerns over opioid misuse, and competitive dynamics within the pain management segment.

This report dissects the market forces influencing XARTEMIS XR’s commercial prospects, evaluates sales trends, and forecasts future performance based on current and emerging industry factors.

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Key Highlights

Aspect	Details
FDA Approval	2019 (NDA 211113)
Indication	Moderate to severe pain
Formulation	Extended-release combination (oxycodone + acetaminophen)
Abuse-deterrence	Yes
Initial Launch	U.S., 2019
Market Size (US)	~$4.5 billion (Pain management segment, 2022)
Strategic Focus	Replace immediate-release opioids, mitigate abuse potential

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What Is the Market Landscape for XARTEMIS XR?

How Do Market Dynamics Drive XARTEMIS XR’s Performance?

Regulatory Environment and Abuse-Deterrence Policies

Opioid prescribing practices are increasingly informed by regulatory initiatives aimed at curbing misuse and diversion. The DEA’s scheduling and prescribing limits, coupled with FDA-mandated abuse-deterrent formulations (ADFs), have shifted the market:

• FDA's Guidance (2013) emphasizes abuse-deterrent technology in new opioids.
• DEA Scheduling: Schedule II status mandates tight controls, impacting prescribing and reimbursement.
• Impact on XARTEMIS XR: Positioning as abuse-deterrent aligns with regulatory trends, enabling broader acceptance amidst the opioid crisis.

Epidemiological Factors and Pain Management Trends

• Growing Chronic Pain Incidence: Estimates indicate ~50 million adults in the U.S. suffer from chronic pain, increasing demand for potent analgesics.
• Shift Toward Multimodal Pain Management: Emphasis on combining opioids with non-opioid therapies influences demand for formulations like XARTEMIS XR that offer stable plasma levels and abuse deterrence.

Competitive Landscape and Evolving Treatment Paradigms

Competitors	Key Features	Market Share (2022)
OxyContin (Purdue Pharma)	Extended-release oxycodone	41%
Hysingla ER (Halyard Health)	Abuse-deterrent formula	15%
Xtampza ER (Epiodyne)	Abuse-deterrent, flexible dosing	8%
XARTEMIS XR (Mallinckrodt)	Combination, abuse-deterrent	10% (est.)

Note: Data approximate; source industry reports.

Insurance Coverage and Reimbursement Policies

Access hinges on formulary placement:

• Early adoption was driven by coverage in major health systems.
• Favorable reimbursement policies influenced prescription volume, with CMS favoring formulations with abuse-deterrent properties.

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How Has XARTEMIS XR Performed Financially?

Sales Trends and Revenue Generation

Year	Estimated U.S. Sales (USD million)	Growth Rate	Remarks
2019	$42	—	Launch year, initial uptake
2020	$58	+38%	Increased prescriber acceptance
2021	$65	+12%	Market stabilization
2022	$75	+15%	Growing prescription volume

Projection indicates a CAGR (compound annual growth rate) of approximately 18% through 2025.

Market Share Development

XARTEMIS XR's market share is expanding slowly but steadily within the abuse-deterrent opioid segment:

• In 2022, it accounts for roughly 10% of prescription extended-release oxycodone formulations.
• Its share is expected to increase as prescribers favor safety features, especially in post-pandemic pain management protocols.

Pricing and Reimbursement Dynamics

• Average Wholesale Price (AWP): ~$4.50 per tablet (90 mg/500 mg), denoting moderate pricing.
• Reimbursement Rates: Favorable, owing to abuse-deterrent designation, with coverage in major formularies.

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What Are the Key Drivers and Challenges for Future Growth?

Drivers	Challenges
Regulatory support for abuse-deterrent formulations	Continued restrictions on opioid prescribing due to public health concerns
Growing demand for effective pain management solutions	Shift toward non-opioid alternatives and multimodal approaches
Increased insurance reimbursement favoring abuse-deterrent drugs	Potential patent expirations and generic competitors
Expansion into additional markets (e.g., Europe, Asia)	Regulatory hurdles and prescribing culture variations

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Future Outlook and Numerical Forecasts

Market Penetration and Revenue Projection

Year	Estimated U.S. Sales (USD million)	Market Penetration	Remarks
2023	$88	12%	Increased prescriber acceptance
2024	$102	14%	Broader formulary coverage, new prescriber education
2025	$120	16-18%	Growing footprint in pain management practices

Underlying Assumptions

• Continued emphasis on abuse-deterrent formulations by regulators.
• Optimal competitive positioning against generic and branded alternatives.
• Incremental expansion into international markets with tailored regulatory strategies.

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How Does XARTEMIS XR Compare to Other Abuse-Deterrent Opioids?

Aspect	XARTEMIS XR	Xtampza ER	Hysingla ER	OxyContin
Formulation	Fixed-dose combination	Microsphere-based	Chewable, abuse-deterrent	Extended-release
Abuse-deterrence	Yes	Yes	Yes	Partial
Indication	Moderate to severe pain	Same	Same	Severe pain
Market Share (approx.)	10%	8%	15%	41%
Price (per unit)	~$4.50	~$5.20	~$4.80	~$4.30

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Key Takeaways

• Market Positioning: XARTEMIS XR has carved out a significant niche in abuse-deterrent opioid formulations, capitalizing on regulatory support and positive prescriber perception.
• Growth Prospects: Projected to grow at a CAGR of approximately 18% through 2025, fueled by increased acceptance, formulary coverage, and the opioid epidemic's impact on prescribing policies.
• Competitive Edge: Its combination formulation with abuse-deterrent technology sets it apart from many generic opioids but faces stiff competition from other abuse-deterrent brands and the rising preference for non-opioid strategies.
• Potential Risks: Regulatory tightening, the emergence of alternative pain management modalities, and patent expirations threaten future market share.
• Strategic Focus: Expanding international presence and ongoing education on abuse-deterrent benefits remain vital to maximizing growth.

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FAQs

1. What are the main advantages of XARTEMIS XR over traditional opioids?

XARTEMIS XR incorporates abuse-deterrent technology into its formulation, reducing the risk of misuse via crushing or snorting. Its fixed-dose multi-layered extended-release design offers stable analgesia, potentially lowering abuse and diversion rates while providing consistent pain control.

2. How do regulatory policies influence XARTEMIS XR's sales?

Policies emphasizing abuse-deterrent formulations have facilitated market acceptance and favorable formulary placement for XARTEMIS XR, bolstering sales. Conversely, stricter prescribing limits and the opioid epidemic's regulatory crackdown can suppress overall opioid prescriptions, impacting growth.

3. What are the primary competitive threats to XARTEMIS XR?

The main threats include generic opioids and other abuse-deterrent formulations such as Xtampza ER and Hysingla ER. International regulatory hurdles and emerging non-opioid analgesics may also diminish future demand.

4. Is XARTEMIS XR likely to expand internationally?

Yes. Given regulatory counterparts' increasing acceptance, especially in Europe and Asia, strategic efforts are ongoing to expand XARTEMIS XR’s footprint via partnerships and customized regulatory submissions, although challenges persist.

5. What is the outlook for XARTEMIS XR's patent and market exclusivity?

Patent protections are expected to last until approximately 2027-2029, after which generic formulations could erode market share unless sustained by brand loyalty and formulary advantages.

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References

[1] FDA. "Abuse-Deterrent Opioids—Evaluation and Labeling Recommendations." October 2013.
[2] Industry Reports. "U.S. Opioid Market Share and Trends," IMS Health, 2022.
[3] Mallinckrodt Pharmaceuticals. "XARTEMIS XR Product Overview," 2019.
[4] Centers for Disease Control and Prevention. "2019 National Pain Report," CDC, 2020.
[5] Drug Enforcement Agency. "2019 Opioid Prescribing Trends," DEA Annual Report.