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Serving hundreds of leading biopharmaceutical companies globally:

Merck
US Department of Justice
Daiichi Sankyo
Accenture
Deloitte
Cerilliant
Teva
Queensland Health
Dow

Generated: August 15, 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-three suppliers are listed for this compound. Additional details are available on the acetaminophen; oxycodone hydrochloride profile page.

Drug patent expirations by year for XARTEMIS XR
Generic Entry Opportunity Date for XARTEMIS XR
Generic Entry Date for XARTEMIS XR*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET, EXTENDED RELEASE;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for XARTEMIS XR
Drug ClassOpioid Agonist
Mechanism of ActionFull Opioid Agonists
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 ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Mallinckrodt Inc XARTEMIS XR acetaminophen; oxycodone hydrochloride TABLET, EXTENDED RELEASE;ORAL 204031-001 Mar 11, 2014 DISCN Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Mallinckrodt Inc XARTEMIS XR acetaminophen; oxycodone hydrochloride TABLET, EXTENDED RELEASE;ORAL 204031-001 Mar 11, 2014 DISCN Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Mallinckrodt Inc XARTEMIS XR acetaminophen; oxycodone hydrochloride TABLET, EXTENDED RELEASE;ORAL 204031-001 Mar 11, 2014 DISCN Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Mallinckrodt Inc XARTEMIS XR acetaminophen; oxycodone hydrochloride TABLET, EXTENDED RELEASE;ORAL 204031-001 Mar 11, 2014 DISCN Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
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 Date
➤ Subscribe Extended-release Tablets 7.5 mg/325 mg ➤ Subscribe ➤ Try a Free Trial

Premature patent expiration for: XARTEMIS XR

Expiration due to failure to pay maintenance fee

Patent Number Tradename Expiration Date
➤ Try a Free Trial XARTEMIS XR ➤ Try a Free Trial

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

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Serving hundreds of leading biopharmaceutical companies globally:

Cantor Fitzgerald
Chinese Patent Office
Accenture
Citi
Deloitte
Colorcon
Boehringer Ingelheim
Fuji
US Department of Justice

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.