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Last Updated: April 1, 2020

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XARTEMIS XR Drug 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 thirteen patents protecting this drug and one Paragraph IV challenge.

This drug has forty-nine patent family members in twenty countries.

The generic ingredient in XARTEMIS XR is acetaminophen; oxycodone hydrochloride. There are sixty-six drug master file entries for this compound. Forty-two suppliers are listed for this compound. Additional details are available on the acetaminophen; oxycodone hydrochloride profile page.

US ANDA Litigation and Generic Entry Outlook for Xartemis Xr

There have been fourteen 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

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Drug Sales Revenue Trends for XARTEMIS XR

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Recent Clinical Trials for XARTEMIS XR

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

SponsorPhase
MallinckrodtPhase 4
Lotus Clinical Research, LLCPhase 4

See all XARTEMIS XR clinical trials

Recent Litigation for XARTEMIS XR

Identify potential future generic entrants

District Court Litigation
Case NameDate
MALLINCKRODT LLC v. WATSON LABORATORIES, INC.- FLORIDA2015-06-05
Depomed Inc. v. Watson Laboratories Inc. - Florida2013-02-28
Purdue Pharma LP v. Sandoz Inc.2012-10-10

See all XARTEMIS XR litigation

Synonyms for XARTEMIS XR
731850-86-5
Acetaminophen / oxycodone hydrochloride
Acetaminophen and oxycodone hydrochloride
Acetaminophen mixture with oxycodone hydrochloride
DTXSID40223433
LS-187810
SCHEMBL2516628

US Patents and Regulatory Information for XARTEMIS XR

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   Start Trial   Start Trial   Start Trial
Mallinckrodt Inc XARTEMIS XR acetaminophen; oxycodone hydrochloride TABLET, EXTENDED RELEASE;ORAL 204031-001 Mar 11, 2014 DISCN Yes No   Start Trial   Start Trial Y   Start Trial
Mallinckrodt Inc XARTEMIS XR acetaminophen; oxycodone hydrochloride TABLET, EXTENDED RELEASE;ORAL 204031-001 Mar 11, 2014 DISCN Yes No   Start Trial   Start Trial   Start Trial
Mallinckrodt Inc XARTEMIS XR acetaminophen; oxycodone hydrochloride TABLET, EXTENDED RELEASE;ORAL 204031-001 Mar 11, 2014 DISCN Yes No   Start Trial   Start Trial Y   Start Trial
>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
  Start Trial XARTEMIS XR   Start Trial

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Serving leading biopharmaceutical companies globally:

Dow
Mallinckrodt
Harvard Business School
Merck
AstraZeneca
McKinsey

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