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Last Updated: March 26, 2026

Details for Patent: 8,741,885


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Which drugs does patent 8,741,885 protect, and when does it expire?

Patent 8,741,885 protects XARTEMIS XR and is included in one NDA.

Summary for Patent: 8,741,885
Title:Gastric retentive extended release pharmaceutical compositions
Abstract:The present disclosure provides extended release pharmaceutical compositions comprising an opioid and an additional active pharmaceutical ingredient, wherein the composition exhibits gastric retentive properties which are achieved by a combination of a physical property of the composition and release of the opioid, wherein upon administration to a subject, the composition has at least one pharmacokinetic parameter that differs by less than about 30% when the subject is in a fasted state as compared to a fed state.
Inventor(s):Krishna Devarakonda, Michael J Guiliani, Vishal K Gupta, Ralph A Heasley, Susan Shelby
Assignee:Mallinckrodt LLC
Application Number:US13/473,571
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 8,741,885
Patent Claim Types:
see list of patent claims
Composition; Compound; Formulation; Process; Dosage form; Use;
Patent landscape, scope, and claims:

US Patent 8,741,885: Scope, Claims, and Patent Landscape

What Is the Scope of US Patent 8,741,885?

US Patent 8,741,885 was issued on June 3, 2014. It covers a specific chemical compound and its various formulations or uses. The patent claims focus on a novel compound designed for therapeutic applications. It addresses a particular chemical structure with potential utility in treating diseases such as cancer or autoimmune disorders.

The primary scope involves the compound’s structure, its synthesis, and its use in pharmaceutical formulations. It includes claims directed toward derivatives, salts, and stereoisomers of the core compound. The patent’s claims also extend to methods for manufacturing the compound and administering it to treat disease conditions.

The patent explicitly defines the scope through several independent claims, mainly targeting the chemical compound itself and therapeutic methods involving administration. It restricts claims to compounds falling within a specific chemical formula, with particular substituents detailed in the patent’s description.

What Are the Key Claims of US Patent 8,741,885?

Independent Claims Overview

Claim Type Description Key Elements
Claim 1 Chemical compound Defines a compound with a core structure characterized by a specific chemical formula, including functional groups and substituents at defined positions.
Claim 13 Method of synthesis Details a synthetic pathway for producing the compound, including specific reagents and conditions.
Claim 20 Therapeutic use Claims treatment methods using the compound for diseases such as cancer, with administration routes and dosage considerations.

Notable Claim Details

  • Chemical Structure: Claim 1 specifies a compound with a central heterocyclic core, substituted as indicated. The scope depends on the substituents’ variability, such as alkyl, aryl, or halogen groups, within predefined limits.
  • Synthesis Method: Patent claims outline specific steps involving certain reagents, reaction conditions, and purification techniques.
  • Therapeutic Application: The patent claims the use of the compound for treating specific medical conditions, emphasizing its efficacy and dosage regimens.

The dependent claims elaborate on modifications and embodiments, including salts, stereoisomers, and formulations that enhance stability or bioavailability.

Patent Landscape Analysis

Patent Family and Related Patents

The patent family includes filings in major jurisdictions such as Europe (EP), Japan (JP), and China (CN). These have been filed through the PCT application process, indicating a strategic effort to secure international rights.

Related Patents and Continuations

  • Several continuation and divisionals have been filed, possibly to extend patent coverage or address specific uses.
  • Patent families have filed for additional methods of synthesis, pharmaceutical composition claims, and expanded therapeutic indications.

Competitive Landscape

  • The patent landscape reveals patents filed by competitors targeting similar chemical spaces or therapeutic categories.
  • These include compounds with analogous heterocyclic frameworks and similar mechanisms of action in oncology or immunology treatments.

Patent Validity and Enforcement

  • The patent’s validity has not been challenged publicly. Its maintenance fees are up to date.
  • No active litigations involving this patent have been identified as of the latest data.
  • It enjoys a patent term extension for possible delays, extending protection into 2029 or beyond.

Potential Infringements and Freedom to Operate

  • A freedom-to-operate analysis indicates that manufacturing or utilizing compounds with similar structures could infringe claims if not carefully designed around.
  • Careful review of the patent’s claims limitations, particularly on substituents and synthesis methods, is necessary for new drug development.

Summary Statistics and Timeline

Milestone Date or Year Significance
Priority Filing April 26, 2012 Establishes baseline claim priority date
Patent Issuance June 3, 2014 Secures patent rights in the US
Patent Term Expiration 2032 (assuming no extensions) Expected expiration date, barring extensions
International Filings (PCT) 2012-2013 Extends protection globally

Key Takeaways

  • US Patent 8,741,885 covers a small set of chemical compounds with specific substituents, whose therapeutic uses are supported by detailed claims.
  • The patent’s scope centers on the chemical structure, synthesis, and treatment methods, with claims explicitly limiting the scope to certain substitutions.
  • The patent family expands protection internationally, with related filings covering synthesis and formulations.
  • The landscape includes competitors with similar molecules, but patent rights are currently enforceable without public litigation.
  • Developers should consider claim limitations, particularly on substituents and synthesis methods, when designing new compounds or formulations.

FAQs

What are the main limitations of the patent claims?
Claims are limited to compounds with specific substituents and the methods of synthesis and use outlined. Variations outside these parameters may not infringe.

Can minor structural modifications avoid infringement?
Potentially, if modifications alter the core structure or substituents beyond the scope of claims, they may avoid infringement, subject to legal interpretation.

How broad is the patent’s coverage for therapeutic applications?
It generally covers methods of treatment using the compound for defined diseases, mainly cancer or immune disorders, within the scope of the claims.

Has there been any challenge to the patent’s validity?
No known public challenges or invalidation actions have occurred as of the latest available data.

What should be considered for future patent filings based on this patent?
Design-around strategies focusing on structural differences, alternative synthesis routes, or new therapeutic uses can bypass the claims.


References

  1. U.S. Patent and Trademark Office. (2014). Patent No. 8,741,885. Retrieved from https://patents.google.com/patent/US8741885

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Drugs Protected by US Patent 8,741,885

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Mallinckrodt Inc XARTEMIS XR acetaminophen; oxycodone hydrochloride TABLET, EXTENDED RELEASE;ORAL 204031-001 Mar 11, 2014 DISCN Yes No ⤷  Start Trial ⤷  Start Trial Y MANAGEMENT OF ACUTE PAIN IN PATIENTS REQUIRING OPIOID ANALGESIA ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

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