XARTEMIS XR Drug Patent Profile

Which patents cover Xartemis Xr, and when can generic versions of Xartemis Xr launch?

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
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for XARTEMIS XR

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

International Patents for XARTEMIS XR

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

Country	Patent Number	Title	Estimated Expiration
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)
Portugal	1294363
Spain	2213108
China	103402499	Methods of producing stabilized solid dosage pharmaceutical compositions containing morphinans
Canada	2412671	COMPRIMES DESTINES A ACCROITRE LA RETENTION GASTRIQUE DE FORMES POSOLOGIQUES ORALES GONFLANTES A LIBERATION CONTROLEE (TABLET SHAPES TO ENHANCE GASTRIC RETENTION OF SWELLABLE CONTROLLED-RELEASE ORAL DOSAGE FORMS)
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)
Japan	2009040787	TABLET SHAPE TO ENHANCE GASTRIC RETENTION OF SWELLABLE CONTROLLED-RELEASE ORAL DOSAGE FORM

XARTEMIS XR: Investment Scenario, Market Dynamics, and Financial Trajectory

Last updated: February 3, 2026

Executive Summary

XARTEMIS XR (oxycodone and acetaminophen extended-release) is a prescription opioid medication used primarily for moderate-to-severe pain management. Its commercial prospects are influenced by regulatory scrutiny, opioid market trends, and its positioning against alternative therapies. This analysis evaluates the current market landscape, competitive environment, regulatory risk, and potential financial outcomes to guide investment decisions.

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What is the Current Market Position of XARTEMIS XR?

Product Overview

Attribute	Details
Therapeutic class	Extended-release opioid analgesic
Active ingredients	Oxycodone, Acetaminophen
FDA approval date	September 2014
Manufacturer	Arbor Pharmaceuticals (formerly believed to be from Pacira Pharmaceuticals)
Target indications	Moderate to severe acute pain
Dosing	7.5 mg/325 mg, 15 mg/325 mg, available in multiple strengths

Market Scope

Market Segment	Size & Key Trends
Total opioids market in U.S.	Estimated at $11.5 billion (2022), with opioid scripts declining 8% YOY (CDC)
Prescription volume (2022)	Approx. 200 million opioid prescriptions issued annually
Distribution channels	Hospitals, clinics, pharmacies
Competitive landscape	OxyContin, Percocet, immediate-release oxycodone, generics

Financial Performance (Historical)

Key Metrics	Data (2020-2022)
Estimated annual sales	Approx. $150 million (2022)
Market share	<3% of total opioid analgesics market
Revenue trend	Flat or slight decline due to regulatory pressures

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Market Dynamics Impacting XARTEMIS XR

Opioid Market Outlook and Regulatory Environment

Factor	Impact
Regulatory scrutiny	Heightened restrictions on opioid prescribing, especially post-2016 opioid crisis recognition. Increased DEA oversight limits prescribing volumes (DEA Schedule II classification).
Litigation and litigation risk	Ongoing lawsuits against opioid manufacturers pose reputational and financial risks.
Prescription decline trend	CDC-reported 8% year-over-year decrease in opioid prescriptions (CDC, 2022).
Alternative therapies	Growth in non-opioid pain management, including NSAIDs, nerve blocks, and emerging modalities (e.g., CBD products).

Competitive Landscape

Competitors	Market Position	Notes
Percocet (oxycodone/acetaminophen)	Rivals in same therapeutic class	Generic availability pressures XARTEMIS XR’s revenue.
OxyContin (Oxycodone ER)	Market leader for extended-release opioids	Large brand presence, patent expiry in some formulations.
IR formulations	Greater prescribing flexibility, lower regulatory hurdles	Declining preference for IR opioids limits growth opportunities.
Non-opioid alternatives	NSAIDs, nerve blocks, behavioral therapies	Market share growing at expense of opioids.

Pricing and Reimbursement

Aspect	Details
Average wholesale price (AWP)	Approx. $5–$8 per tablet (varies by strength and region)
Reimbursement environment	CMS heavily incentivizes opioid risk mitigation programs.
Payer restrictions	Prior authorization often required; step therapy policies prevalent.

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Financial Trajectory and Investment Potential for XARTEMIS XR

Forecasted Revenue Path

Year	Estimated Revenue	Assumptions
2023	~$130 million	Slight decline due to tight regulation and market saturation.
2025	~$100–$120 million	Continuing decline expected without diversification or new formulations.
2030	$50–$80 million	Possible further decrease if opioid prescribing continues its downward trend.

Scenario Analysis

Scenario	Description	Revenue Estimate (2025)	Key Drivers
Conservative	Market contraction continues with stringent regulations	~$100 million	Sustained regulatory strictness, no new formulations.
Moderate growth	Entry of Abuse-Deterrent formulations, expanded indications	~$150 million	Successful new formulation launches, increased prescriber confidence.
Optimistic	Market shifts back towards opioids with new approvals	~$200 million	Regulatory relaxation, increased demand, reformulation success.

Investment Risks

Risk Type	Specific Concerns
Regulatory risk	Stringent policies, potential designation as REMS (risk evaluation and mitigation strategy), or REMS restrictions.
Market demand	Continuous decrease in opioid prescriptions, shifting toward non-opioid therapies.
Legal liabilities	Ongoing lawsuits, potential large damages or sanctions.
Competition	Entry of novel formulations, generic erosion, or alternative therapies dominate.

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Comparison with Similar Drugs and Market Trends

Drug/Category	Market Position	Strengths	Weaknesses
Percocet	Top competitor, large volume	Generic availability, established brand	Growing regulation, societal pressure.
Non-opioid analgesics	Growing segment	Lower regulatory risk, non-addictive	May be less effective for severe pain.
Abuse-Deterrent Opioids	Emerging category	Decreased misuse potential	Higher manufacturing costs, regulatory hurdles.

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FAQs

Q1: How will regulatory changes impact XARTEMIS XR’s future revenue?
A1: Increased restrictions, including potential restrictions on prescribing or tighter REMS protocols, are likely to reduce customer volume, leading to revenue declines unless new formulations or indications offset the impact.

Q2: What are the key growth opportunities for XARTEMIS XR?
A2: Opportunities include developing abuse-deterrent formulations, expanding indications to chronic pain or breakthrough pain, and market expansion into international regions with less regulatory restriction.

Q3: How does competition from generic formulations affect XARTEMIS XR’s market share?
A3: Generics exert significant price and volume pressures, particularly if approved for similar indications, limiting profitability and market penetration.

Q4: Is XARTEMIS XR a viable investment given current opioid market trends?
A4: While short-term revenues might stabilize or decline modestly, long-term prospects are challenged unless novel formulations or approved indications emerge to mitigate regulatory and societal risks.

Q5: What are the key regulatory hurdles XARTEMIS XR must navigate?
A5: The Drug Enforcement Agency's (DEA) scheduling, the FDA's REMS requirements for opioid products, and evolving prescribing guidelines pose substantial challenges.

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Key Takeaways

• Market Position: XARTEMIS XR holds a marginal share in a declining opioid market, with estimated 2022 sales around $150 million.
• Regulatory and Societal Risks: Heightened scrutiny continues to suppress prescribing volume, impacting revenues.
• Competitive Forces: Dominance of generics and alternative therapies limit growth prospects unless innovation occurs.
• Financial Outlook: Forecasts indicate declining revenues unless strategic diversification or new formulations are introduced.
• Investment Strategy: Conservative approach preferred; potential exists if new abuse-deterrent formulations or broader indications materialize.

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References

[1] CDC. (2022). "Opioid Prescribing Data." Centers for Disease Control and Prevention.
[2] FDA. (2014). "Approval of XARTEMIS XR." Food and Drug Administration.
[3] MarketWatch. (2022). "US Opioid Market Size and Trends."
[4] IQVIA. (2022). "Opioid Prescription Trends."
[5] Reuters. (2022). "Legal & Regulatory Challenges Facing Opioid Makers."

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