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Serving leading biopharmaceutical companies globally:

McKinsey
Medtronic
Novartis
US Department of Justice
McKesson
US Army
Teva
Fish and Richardson
Argus Health
Dow

Generated: February 17, 2018

DrugPatentWatch Database Preview

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-eight patent family members in nineteen countries.

The generic ingredient in XARTEMIS XR is acetaminophen; oxycodone hydrochloride. There are sixty-six drug master file entries for this compound. Fifty-one suppliers are listed for this compound. Additional details are available on the acetaminophen; oxycodone hydrochloride profile page.
Summary for XARTEMIS XR
Drug patent expirations by year for XARTEMIS XR
Pharmacology for XARTEMIS XR
Drug ClassOpioid Agonist
Mechanism of ActionFull Opioid Agonists

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

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Paragraph IV (Patent) Challenges for XARTEMIS XR
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Extended-release Tablets 7.5 mg/325 mg ➤ Subscribe 4/3/2014

Non-Orange Book US Patents for XARTEMIS XR

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
9,433,582 Gastric retentive extended release pharmaceutical compositions ➤ Sign Up
9,198,861 Methods of producing stabilized solid dosage pharmaceutical compositions containing morphinans ➤ Sign Up
9,629,837 Pharmaceutical compositions for extended release of oxycodone and acetaminophen resulting in a quick onset and prolonged period of analgesia ➤ Sign Up
8,790,694 Gastric retentive extended release pharmaceutical compositions ➤ Sign Up
8,858,963 Tamper resistant composition comprising hydrocodone and acetaminophen for rapid onset and extended duration of analgesia ➤ Sign Up
9,539,328 Tamper resistant composition comprising hydrocodone and acetaminophen for rapid onset and extended duration of analgesia ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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International Patents for XARTEMIS XR

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Serving hundreds of leading biopharmaceutical companies globally:

Covington
Harvard Business School
Cantor Fitzgerald
Colorcon
Chinese Patent Office
Argus Health
Fish and Richardson
Cipla
QuintilesIMS

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 verifification 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.

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