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Last Updated: May 19, 2022

XARTEMIS XR Drug Patent Profile


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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 eleven 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

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Drug patent expirations by year for XARTEMIS XR
Drug Prices for XARTEMIS XR

See drug prices for XARTEMIS XR

Drug Sales Revenue Trends for XARTEMIS XR

See drug sales revenues for XARTEMIS XR

Recent Clinical Trials for XARTEMIS XR

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

SponsorPhase
Lotus Clinical Research, LLCPhase 4
MallinckrodtPhase 4

See all XARTEMIS XR clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for XARTEMIS XR

US Patents and Regulatory Information for XARTEMIS XR

XARTEMIS XR is protected by twelve US patents.

Patents protecting XARTEMIS XR

Gastric retentive oral dosage form with restricted drug release in the lower gastrointestinal tract
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF TREATING PATIENTS WITH GASTRIC RETENTIVE DOSAGE FORM

Gastric retentive extended-release dosage forms comprising combinations of a non-opioid analgesic and an opioid analgesic
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: MANAGEMENT OF ACUTE PAIN IN PATIENTS REQUIRING OPIOID ANALGESIA

Gastric retentive extended-release dosage forms comprising combinations of a non-opioid analgesic and an opioid analgesic
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: MANAGEMENT OF ACUTE PAIN IN PATIENTS REQUIRING OPIOID ANALGESIA

Gastric retentive extended-release dosage forms comprising combinations of a non-opioid analgesic and an opioid analgesic
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Methods of producing stabilized solid dosage pharmaceutical compositions containing morphinans
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Combination composition comprising oxycodone and acetaminophen for rapid onset and extended duration of analgesia
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Gastric retentive extended-release dosage forms comprising combinations of a non-opioid analgesic and an opioid analgesic
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: MANAGEMENT OF ACUTE PAIN IN PATIENTS REQUIRING OPIOID ANALGESIA

Gastric retentive extended release pharmaceutical compositions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: MANAGEMENT OF ACUTE PAIN IN PATIENTS REQUIRING OPIOID ANALGESIA

Methods of producing stabilized solid dosage pharmaceutical compositions containing morphinans
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Combination composition comprising oxycodone and acetaminophen for rapid onset and extended duration of analgesia
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Pharmaceutical compositions for extended release of oxycodone and acetaminophen resulting in a quick onset and prolonged period of analgesia
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Combination composition comprising oxycodone and acetaminophen for rapid onset and extended duration of analgesia
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: MANAGEMENT OF ACUTE PAIN IN PATIENTS REQUIRING OPIOID ANALGESIA

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

Premature patent expiration for: XARTEMIS XR

Expiration due to failure to pay maintenance fee

Patent Number Tradename Expiration Date
See Plans and Pricing XARTEMIS XR See Plans and Pricing

International Patents for XARTEMIS XR

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

Country Patent Number Title Estimated Expiration
Japan 2014500315 See Plans and Pricing
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) See Plans and Pricing
Japan 2003535886 See Plans and Pricing
World Intellectual Property Organization (WIPO) 2009114648 See Plans and Pricing
World Intellectual Property Organization (WIPO) 03035041 See Plans and Pricing
European Patent Office 1439826 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

Dow
Mallinckrodt
Harvard Business School
Merck
AstraZeneca
McKinsey

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.