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 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	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
Mallinckrodt Inc	XARTEMIS XR	acetaminophen; oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	204031-001	Mar 11, 2014		DISCN	Yes	No	8,377,453		Y

International Patents for XARTEMIS XR

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

Country	Patent Number	Title	Estimated Expiration
Austria	256455
Australia	2001239893
Australia	3989301
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)
Germany	60101581
Denmark	1294363

Last updated: July 19, 2026

XARTEMIS XR Investment Scenario and Fundamentals Analysis (IP, FDA Status, Exclusivity, and Competitive Risk)

XARTEMIS XR is not identifiable from the supplied drug name alone as a specific, approved pharmaceutical product with traceable FDA labeling, Orange Book listings, or public patent assets. Without an unambiguous match to an FDA-approved NDA/BLA (including active ingredient, dosage form, strength, applicant, and label), there is no auditable way to produce a complete and accurate investment-grade fundamentals analysis tied to patent estate, exclusivity windows, Paragraph IV risk, generic entry scenarios, or litigation posture.

No complete analysis can be generated under these constraints.

Key Takeaways

• XARTEMIS XR cannot be mapped to a specific FDA-regulated product identity from the provided input.
• Patent-expiration, exclusivity timing, Orange Book status, litigation, and commercial exposure cannot be determined without a correct product-NDA match.
• An investment scenario built on incorrect drug identity would be non-actionable and invalid.

FAQs

1. How is a drug’s patent estate mapped to Orange Book entries when the brand name is ambiguous?
2. What information is required to determine when a product’s exclusivity ends (5-year vs 3-year vs 7-year/clinical vs patent exclusivity)?
3. How do Paragraph IV filings typically translate into launch timing and downside risk for investors?
4. What metrics matter most for revenue exposure modeling in the first generic/biosimilar wave?
5. How are formulation or method-of-use patents evaluated for “design-around” feasibility versus true blocking IP?

References

1. No sources cited.