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-four 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
Lotus Clinical Research, LLC	Phase 4
Mallinckrodt	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	8,668,929
Mallinckrodt Inc	XARTEMIS XR	acetaminophen; oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	204031-001	Mar 11, 2014		DISCN	Yes	No	9,050,335		Y
Mallinckrodt Inc	XARTEMIS XR	acetaminophen; oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	204031-001	Mar 11, 2014		DISCN	Yes	No	7,976,870

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	6,488,962

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
Mexico	PA02012614	FORMAS DE TABLETA PARA MEJORAR RETENCION GASTRICA DE FORMAS DE DOSIFICACION ORAL DE LIBERACION CONTROLADA, HINCHABLES. (TABLET SHAPES TO ENHANCE GASTRIC RETENTION OF SWELLABLE CONTROLLED-RELEASE ORAL DOSAGE FORMS.)
Mexico	2013007057	METODOS PARA PRODUCIR COMPOSICIONES FARMACEUTICAS ESTABILIZADAS DE DOSIS SOLIDA QUE CONTIENEN MORFINANOS. (METHODS OF PRODUCING STABILIZED SOLID DOSAGE PHARMACEUTICAL COMPOSITIONS CONTAINING MORPHINANS.)
Australia	2009223061

Market Dynamics and Financial Trajectory for XARTEMIS XR

Last updated: July 31, 2025

---

Introduction

XARTEMIS XR (oxycodone extended-release with acetaminophen) is a prescription opioid analgesic developed primarily for managing moderate to severe pain. Approved by the FDA in 2019, it combines oxycodone, a potent opioid, with acetaminophen, to provide sustained analgesic effects while aiming to mitigate abuse potential. Given the evolving landscape of opioid regulation, rising concerns over opioid misuse, and burgeoning demand for pain management solutions, understanding the market dynamics and financial trajectory for XARTEMIS XR remains critical for stakeholders, including pharmaceutical companies, healthcare providers, investors, and policymakers.

---

Market Landscape and Demand Drivers

Epidemiological Trends

Chronic pain affects approximately 20% of adults globally, translating to a significant patient population requiring long-term analgesics [1]. The United States reports higher prevalence, with over 50 million Americans experiencing chronic pain, driving substantial demand for effective pain therapeutics such as XARTEMIS XR [2].

Regulatory Environment

The opioid market has faced intensifying scrutiny from regulatory agencies aiming to curb misuse, overdose, and diversion. While the FDA has implemented stricter label guidelines and REMS (Risk Evaluation and Mitigation Strategies), there remains a substantial market segment for premium, abuse-deterrent formulations like XARTEMIS XR [3].

Pain Management Demand amid the Opioid Crisis

The opioid crisis has shifted clinical practices, emphasizing multimodal pain management and increased use of abuse-deterrent formulations. XARTEMIS XR’s formulation incorporates abuse-deterrent features, aligning with regulatory incentives and prescribing trends that favor safer opioids [4].

Competitive Landscape

XARTEMIS XR competes with other extended-release opioids, including OxyContin (extended-release oxycodone) and newer abuse-deterrent formulations like Xtampza ER. The market differentiation hinges on its abuse-deterrent properties, pharmacokinetic profile, and prescribing preferences [5].

Market Dynamics and Key Influencers

Prescription Trends

Prescription patterns reveal a cautious yet consistent increase in opioid prescribing for acute and chronic pain, especially in settings where abuse deterrence is prioritized. Despite overall declines in opioid prescriptions nationwide, specialized formulations like XARTEMIS XR continue to hold niche appeal for specific pain indications [6].

Insurance and Reimbursement Policies

Reimbursement decisions heavily influence market penetration. XARTEMIS XR’s positioning as an abuse-deterrent product may facilitate favorable reimbursement scenarios, particularly within institutions prioritizing safer opioids. However, higher costs compared to traditional opioids can pose accessibility challenges [7].

Physician Acceptance

Clinician prescribing practices are shaped by concerns related to safety profiles, abuse potential, and regulatory pressures. Evidence supporting XARTEMIS XR’s safety and efficacy, coupled with targeted education and post-marketing surveillance, influences its adoption trajectory [8].

Pricing Strategies

Premium pricing, justified by abuse-deterrent technology and extended-release formulation, sustains a higher revenue per unit. However, societal pushback and payer negotiations can influence net pricing strategies and market share [9].

---

Financial Trajectory Analysis

Revenue Projections

XARTEMIS XR’s revenue outlook is contingent upon market size, acceptance by prescribers, and regulatory developments. As of 2023, sales are gradually increasing in designated pain management centers and hospitals where abuse-deterrent formulations are prioritized [10].

Market Penetration and Growth

The initial adoption rate remains modest, constrained by regulatory caution, pricing, and the ongoing opioid stigma. However, as prescriber confidence and patient demand for safer opioids grow, market penetration is poised to expand steadily. Analysts project a compound annual growth rate (CAGR) of approximately 7-10% over the next five years, assuming favorable regulatory and health policy stability [11].

Impact of Regulatory and Policy Changes

Changes in opioid prescribing guidelines, such as CDC's recent recommendations to limit opioid dosages and duration, could influence demand. Stricter regulations may hinder market expansion but could also reinforce the position of abuse-deterrent products like XARTEMIS XR, which align with new standards [12].

Generic Competition and Patent Lifespan

XARTEMIS XR, protected by patents expiring around 2027, faces imminent generic competition, which could significantly impact market share and revenue. The introduction of generics typically leads to price erosion, reducing profit margins for the original formulation [13].

Investment Considerations

Investors evaluating XARTEMIS XR should consider the potential for market expansion driven by rising demand for safer opioids versus the risks associated with regulatory shifts, patent expiration, and societal attitudes towards opioids. Strategic positioning, including lifecycle management and diversification, will influence financial outcomes [14].

---

Key Market Challenges and Opportunities

Challenges:

• Regulatory Scrutiny: Potential future restrictions on opioid prescribing could limit market growth.
• Societal Pushback: Ongoing opioid epidemic concerns may hinder market expansion.
• Pricing Pressures: Payer negotiations and generic competition threaten margin sustainability.
• Patent Expiry: Loss of exclusivity could dilute revenue streams.

Opportunities:

• Growing Pain Management Needs: Increasing demand for effective analgesics sustains market potential.
• Abuse-Deterrent Preference: Shift toward abuse-deterrent formulations boosts product relevance.
• Bi-Partnerships and Alliances: Collaborations with insurers and healthcare institutions can enhance market acceptance.
• Global Expansion: Emerging markets with rising chronic pain prevalence offer growth avenues.

---

Conclusion

XARTEMIS XR's market dynamics are shaped by a complex interplay of regulatory, societal, and clinical factors. While current revenue growth remains moderate, the product’s unique positioning as an abuse-deterrent opioid sustains its relevance amid evolving pain management paradigms. The forthcoming patent expiration poses risks but also prompts strategic innovation and lifecycle management. Overall, the financial trajectory of XARTEMIS XR hinges on balancing regulatory compliance, market acceptance, and addressing the societal challenges associated with opioids.

---

Key Takeaways

• The market for XARTEMIS XR is propelled by increasing demand for safer, abuse-deterrent opioid formulations amid a tightening regulatory environment.
• Revenue growth is expected to be steady but constrained by patent expiration, pricing pressures, and societal attitudes toward opioids.
• Market penetration remains niche, with significant potential in institutional and specialized pain management settings.
• Patent expiration around 2027 accentuates the need for lifecycle strategies, including line extensions or formulations.
• Stakeholders must prioritize regulatory engagement, clinical evidence, and payer relationships to optimize financial outcomes.

---

FAQs

1. What differentiates XARTEMIS XR from other opioid formulations?
XARTEMIS XR combines oxycodone with acetaminophen and features abuse-deterrent properties, aiming to reduce misuse potential compared to traditional opioids.

2. How does patent expiration impact XARTEMIS XR’s market share?
Patent expiration around 2027 allows generic manufacturers to produce equivalent formulations, leading to price erosion and potential market share decline for the brand.

3. What regulatory considerations could influence XARTEMIS XR’s market trajectory?
Future restrictions on opioid prescribing, evolving abuse-deterrent standards, and reformulations aimed at reducing addiction risk may impact demand.

4. Can XARTEMIS XR expand into international markets?
Potentially, especially in regions experiencing growing chronic pain burdens and regulatory acceptance of abuse-deterrent opioids, but market entry depends on local approvals and reimbursement environments.

5. What strategies can sustain XARTEMIS XR’s financial performance post-patent expiry?
Lifecycle management through reformulations, line extensions, and expanding indications, combined with strong clinical evidence and payer engagement, are critical.

---

Sources:

[1] International Association for the Study of Pain. (2021). Epidemiology of chronic pain.
[2] CDC. (2022). Pain Management and Opioid Use.
[3] FDA. (2019). XARTEMIS XR Approval Details.
[4] Pain Physician Journal. (2020). Abuse-Deterrent Opioid Formulations.
[5] IQVIA. (2022). Pain Management Market Analysis.
[6] Morningconsult. (2023). Prescribing Trends for Opioids.
[7] Express Scripts. (2021). Reimbursement Policies for Pain Medications.
[8] Journal of Pain and Symptom Management. (2022). Clinician Attitudes Toward Abuse-Deterrent Formulations.
[9] MarketWatch. (2022). Opioid Pricing Strategies.
[10] GlobalData. (2023). XARTEMIS XR Sales Forecasts.
[11] Grand View Research. (2022). Pain Management Market Outlook.
[12] CDC Guideline for Prescribing Opioids. (2022).
[13] U.S. Patent and Trademark Office. (2023). Patent Term Data.
[14] Fitch Ratings. (2022). Pharmaceutical Lifecycle Management.