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-five 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 two 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:	3
Clinical Trials:	2
Patent Applications:	11
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
Mallinckrodt Inc	XARTEMIS XR	acetaminophen; oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	204031-001	Mar 11, 2014		DISCN	Yes	No	8,658,631		Y
Mallinckrodt Inc	XARTEMIS XR	acetaminophen; oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	204031-001	Mar 11, 2014		DISCN	Yes	No	8,597,681		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	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
Japan	2009040787	TABLET SHAPE TO ENHANCE GASTRIC RETENTION OF SWELLABLE CONTROLLED-RELEASE ORAL DOSAGE FORM
South Africa	201303988	METHODS OF PRODUCING STABILIZED SOLID DOSAGE PHARMACEUTICAL COMPOSITIONS CONTAINING MORPHINANS
Japan	2003535886
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)
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

XARTEMIS XR Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for XARTEMIS XR

Introduction

XARTEMIS XR, an extended-release oral combination of oxycodone and acetaminophen, was approved by the FDA in March 2014 for the management of acute pain severe enough to require opioid treatment. This approval marked a significant milestone in the pain management market, particularly for Mallinckrodt, the pharmaceutical company behind the drug.

Market Need and Demand

Acute pain management is a critical area in healthcare, with significant economic implications. In 2010, there were over 102 million surgical procedures performed in the U.S., highlighting the vast need for effective pain management solutions[1].

Economic Impact of Unmanaged Pain

Uncontrolled or unmanaged pain results in substantial costs to U.S. businesses due to lost productivity. The economic burden of pain is a driving factor for the development and adoption of effective pain management treatments like XARTEMIS XR.

Unique Selling Proposition

XARTEMIS XR is the first and only extended-release oral combination of oxycodone and acetaminophen. This formulation combines immediate- and extended-release components, providing pain relief in less than one hour and allowing for twice-daily dosing. This unique profile addresses the need for sustained pain relief without the necessity of frequent dosing, which can disrupt patients' sleep patterns[1].

Clinical Efficacy

The FDA approval of XARTEMIS XR was based on a pivotal Phase 3 efficacy study conducted in an acute post-surgical pain model. The study demonstrated statistically significant improvement in pain scores compared to placebo over 48 hours. This clinical evidence supports the drug's effectiveness in managing acute pain[1].

Pharmacokinetics and Safety

The drug's pharmacokinetic profile, which includes both immediate- and extended-release components, is designed to provide consistent pain relief. Safety data from Phase III trials have been presented, evaluating pharmacokinetics in different populations and pooled safety data. These studies have helped establish the safety and tolerability of XARTEMIS XR[4].

Regulatory Environment

XARTEMIS XR is classified as a Schedule II controlled substance due to the risks associated with opioids, including addiction, abuse, misuse, overdose, and death. This classification necessitates careful prescribing and monitoring practices to ensure the drug is used appropriately[1].

Financial Impact

Milestone Payments

The approval of XARTEMIS XR triggered a $10 million milestone payment from Mallinckrodt to Depomed, highlighting the financial significance of this approval[2].

Sales and Marketing Strategy

To support the launch of XARTEMIS XR, Mallinckrodt expanded its sales force by 150 to 200 contracted sales representatives. This strategic move aimed to enhance the commercial infrastructure for the drug and other branded products within the company's portfolio[3].

Revenue Potential

Given its unique formulation and clinical efficacy, XARTEMIS XR has the potential to capture a significant share of the pain management market. The drug's extended-release profile and the need for effective pain management solutions position it as a valuable addition to the pharmaceutical market.

Competitive Landscape

The pain management market is highly competitive, with various opioid and non-opioid analgesics available. However, XARTEMIS XR's unique combination of oxycodone and acetaminophen in an extended-release formulation sets it apart from other products. This differentiation can help the drug stand out in a crowded market[1].

Future Outlook

Mallinckrodt's long-term strategy involves advancing its pipeline products, including XARTEMIS XR, to expand its branded business segment. The company plans to enhance its commercial infrastructure, enter new markets, and pursue strategic acquisitions to further grow its presence in the pain management sector[3].

Risk Factors

Despite the positive outlook, there are several risk factors that could impact the financial trajectory of XARTEMIS XR. These include regulatory changes, competition, challenges in obtaining procurement and production quotas, and the complexities of healthcare reimbursement practices. These risks are detailed in Mallinckrodt's annual reports and other filings[1][4].

Conclusion

XARTEMIS XR represents a significant advancement in acute pain management, offering a unique extended-release formulation that addresses the need for sustained pain relief. The drug's approval and subsequent market entry have been supported by robust clinical evidence and a strategic sales and marketing approach. While there are risks associated with its development and commercialization, XARTEMIS XR has the potential to contribute substantially to Mallinckrodt's financial growth and market presence.

Key Takeaways

• Unique Formulation: XARTEMIS XR is the first extended-release oral combination of oxycodone and acetaminophen.
• Clinical Efficacy: Demonstrated statistically significant improvement in pain scores in a Phase 3 study.
• Market Need: Addresses the significant economic and healthcare burden of acute pain.
• Financial Impact: Triggered a $10 million milestone payment and has potential for substantial revenue.
• Regulatory Environment: Classified as a Schedule II controlled substance.
• Future Outlook: Part of Mallinckrodt's strategy to expand its branded business segment.

FAQs

Q: What is XARTEMIS XR used for? A: XARTEMIS XR is used for the management of acute pain severe enough to require opioid treatment and for which alternative treatment options are inadequate.

Q: What makes XARTEMIS XR unique? A: XARTEMIS XR is the first and only extended-release oral combination of oxycodone and acetaminophen, providing both immediate and extended pain relief.

Q: How was the FDA approval of XARTEMIS XR supported? A: The FDA approval was based on a pivotal Phase 3 efficacy study that showed statistically significant improvement in pain scores compared to placebo.

Q: What are the potential risks associated with XARTEMIS XR? A: The drug is associated with risks of addiction, abuse, misuse, overdose, and death, common with opioids. Other risks include regulatory changes and healthcare reimbursement complexities.

Q: How does XARTEMIS XR fit into Mallinckrodt's business strategy? A: XARTEMIS XR is part of Mallinckrodt's strategy to advance its pipeline products and expand its branded business segment, focusing on pain management solutions.

Sources

1. Mallinckrodt plc Receives FDA Approval For XARTEMIS XR - Mallinckrodt News Release
2. Depomed Earns $10 Million Milestone for FDA Approval of Mallinckrodt's XARTEMIS™ XR - FiercePharma
3. Mallinckrodt public limited company - Investor Relations - Mallinckrodt Investor Relations
4. News Release - News Detail | Mallinckrodt Pharmaceuticals - Mallinckrodt News Release
5. Small-Cap Research - Depomed Presentation[5]