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Serving leading biopharmaceutical companies globally:

McKinsey
Federal Trade Commission
Mallinckrodt
Baxter
Deloitte
US Army
Novartis
UBS
QuintilesIMS
Accenture

Generated: December 12, 2017

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.
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

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Mallinckrodt IncXARTEMIS XRacetaminophen; oxycodone hydrochlorideTABLET, EXTENDED RELEASE;ORAL204031-001Mar 11, 2014DISCNYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
Mallinckrodt IncXARTEMIS XRacetaminophen; oxycodone hydrochlorideTABLET, EXTENDED RELEASE;ORAL204031-001Mar 11, 2014DISCNYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
Mallinckrodt IncXARTEMIS XRacetaminophen; oxycodone hydrochlorideTABLET, EXTENDED RELEASE;ORAL204031-001Mar 11, 2014DISCNYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
Mallinckrodt IncXARTEMIS XRacetaminophen; oxycodone hydrochlorideTABLET, EXTENDED RELEASE;ORAL204031-001Mar 11, 2014DISCNYesNo► Subscribe► Subscribe► Subscribe► Subscribe
Mallinckrodt IncXARTEMIS XRacetaminophen; oxycodone hydrochlorideTABLET, EXTENDED RELEASE;ORAL204031-001Mar 11, 2014DISCNYesNo► Subscribe► Subscribe► Subscribe► Subscribe
Mallinckrodt IncXARTEMIS XRacetaminophen; oxycodone hydrochlorideTABLET, EXTENDED RELEASE;ORAL204031-001Mar 11, 2014DISCNYesNo► Subscribe► Subscribe► Subscribe► Subscribe
Mallinckrodt IncXARTEMIS XRacetaminophen; oxycodone hydrochlorideTABLET, EXTENDED RELEASE;ORAL204031-001Mar 11, 2014DISCNYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
Mallinckrodt IncXARTEMIS XRacetaminophen; oxycodone hydrochlorideTABLET, EXTENDED RELEASE;ORAL204031-001Mar 11, 2014DISCNYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
Mallinckrodt IncXARTEMIS XRacetaminophen; oxycodone hydrochlorideTABLET, EXTENDED RELEASE;ORAL204031-001Mar 11, 2014DISCNYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
Mallinckrodt IncXARTEMIS XRacetaminophen; oxycodone hydrochlorideTABLET, EXTENDED RELEASE;ORAL204031-001Mar 11, 2014DISCNYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
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Paragraph IV (Patent) Challenges for XARTEMIS XR

Drugname Dosage Strength RLD Submissiondate
oxycodone hydrochloride and acetaminophenExtended-release Tablets7.5 mg/325 mgXartemis XR4/3/2014

Non-Orange Book Patents for Tradename: 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
9,198,861Methods of producing stabilized solid dosage pharmaceutical compositions containing morphinans► Subscribe
9,629,837Pharmaceutical compositions for extended release of oxycodone and acetaminophen resulting in a quick onset and prolonged period of analgesia► Subscribe
9,433,582Gastric retentive extended release pharmaceutical compositions► Subscribe
9,539,328Tamper resistant composition comprising hydrocodone and acetaminophen for rapid onset and extended duration of analgesia► Subscribe
8,858,963Tamper resistant composition comprising hydrocodone and acetaminophen for rapid onset and extended duration of analgesia► Subscribe
8,790,694Gastric retentive extended release pharmaceutical compositions► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Tradename: XARTEMIS XR

Country Document Number Estimated Expiration
Germany60101581► Subscribe
World Intellectual Property Organization (WIPO)0197783► Subscribe
South Korea101748906► Subscribe
China102105136► Subscribe
Australia2001239893► Subscribe
Russian Federation2013132138► Subscribe
TaiwanI324075► Subscribe
European Patent Office1294363► Subscribe
MexicoPA04003930► Subscribe
Australia3989301► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Serving leading biopharmaceutical companies globally:

Teva
Julphar
McKesson
Healthtrust
Argus Health
Queensland Health
Novartis
Federal Trade Commission
Accenture
Merck

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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