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Details for Patent: 8,658,631

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Patent 8,658,631 protects XARTEMIS XR and is included in one NDA. There has been one Paragraph IV challenge on Xartemis XR.

Summary for Patent: 8,658,631

Title:Combination composition comprising oxycodone and acetaminophen for rapid onset and extended duration of analgesia
Abstract: The present disclosure provides an extended release pharmaceutical composition comprising oxycodone and acetaminophen that provides a rapid onset of analgesia, and reduced levels of acetaminophen near the end of the dosing interval. Also provided are methods for reducing the risk of acetaminophen-induced hepatic damage in a subject being treated with an acetaminophen containing composition, as well as methods for treating pain in a subject in need thereof.
Inventor(s): Devarakonda; Krishna (St. Louis, MO), Guiliani; Michael J (Creve Coeur, MO), Gupta; Vishal K (Hillsborough, NJ), Heasley; Ralph A (Webster Groves, MO), Shelby; Susan (Creve Coeur, MO)
Assignee: Mallinckrodt LLC (Hazelwood, MO)
Application Number:13/473,563
Patent Claim Types:
see list of patent claims
Composition; Formulation; Compound; Device; Dosage form; Use;
Patent Metrics:
Source: PatentQuant.com
Field: Pharmaceuticals
Back Citations: 0th percentile
Forward Citations: 1st percentile

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use
Mallinckrodt Inc
XARTEMIS XR
acetaminophen; oxycodone hydrochloride
TABLET, EXTENDED RELEASE;ORAL204031-001Mar 11, 2014RXYes8,658,631► subscribeY
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Non-Orange Book Patents for Patent: 8,658,631

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
8,992,975Combination composition comprising oxycodone and acetaminophen for rapid onset and extended duration of analgesia► subscribe
8,741,885Gastric retentive extended release pharmaceutical compositions► subscribe
9,050,335Pharmaceutical compositions for extended release of oxycodone and acetaminophen resulting in a quick onset and prolonged period of analgesia► 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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