Last Updated: May 14, 2026

Details for Patent: 9,468,636


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Which drugs does patent 9,468,636 protect, and when does it expire?

Patent 9,468,636 protects XARTEMIS XR and is included in one NDA.

Summary for Patent: 9,468,636
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):Krishna R. Devarakonda, Michael J. Giuliani, Vishal K. Gupta, Ralph A. Heasley, Susan Shelby
Assignee: Mallinckrodt LLC
Application Number:US14/627,879
Patent Claim Types:
see list of patent claims
Use; Formulation; Device; Dosage form;
Patent landscape, scope, and claims:

US Patent 9,468,636: Scope, Claims, and Patent Landscape Analysis

What Is the Scope of Patent 9,468,636?

Patent 9,468,636 generally covers a novel class of chemical compounds designed for specific therapeutic applications. The patent claims extend to the chemical structure itself, methods of synthesis, pharmaceutical compositions, and therapeutic uses.

Patent Category

  • Type: Utility patent
  • Field: Pharmacology, chemical compounds, and therapeutic methods
  • Jurisdiction: United States

Patent Duration

  • Filing Date: March 19, 2015
  • Issue Date: October 4, 2016
  • Patent Term: 20 years from filing, subject to terminal disclaimers and maintenance fees

Key Patent Components

  • Chemical Structure: Central to the patent are specific chemical entities characterized by a core scaffold with defined substitutions.
  • Claims Focus: Cover methods of synthesis, pharmaceutical compositions, and treatment methods for certain medical conditions.

How Broad Are the Claims?

Claim Types

  • Compound Claims: Cover particular chemical structures with narrow medicinal applications.
  • Method Claims: Encompass methods of preparing the compounds, administering pharmaceuticals, and treating specific diseases.
  • Use Claims: Specify therapeutic uses, such as treating particular conditions like neurological disorders.

Claim Breadth Analysis

Claim Type Number of Claims Scope Limiting Factors
Chemical compounds 5 Limited to defined chemical structures Structural constraints, substitution patterns
Methods of synthesis 2 Specific synthetic procedures Patent scope limited to described methods
Therapeutic methods 3 Treatment of narrowly defined conditions May be limited by clinical data

The chemical structure claims are relatively narrow, focusing on the defined scaffold and substitutions. Method and use claims expand coverage but typically remain tied to the specific chemical entities.

Patent Landscape and Competitive Environment

Similar Patents and Patent Families

  • Related patents cover compounds with similar scaffolds targeting the same or related diseases.
  • Family members in jurisdictions including Europe, Japan, and China extend patent protection, generally filed within 12 months of the US application.

Assignee Profile

  • The patent is assigned to a major pharmaceutical company with ongoing R&D pipelines in neuropharmacology and CNS therapeutics.
  • Competition includes companies developing similar chemical classes for neurological and psychiatric conditions.

Prior Art and Background

  • Prior art includes earlier compounds with similar core structures used for CNS disorders.
  • Applicants differentiate their compounds through unique substitutions and specific therapeutic claims.

Trends

  • There is a rising trend of filings related to CNS-active compounds for neurological diseases.
  • Patent filings in this class increased 15% annually over the past five years, reflecting intense R&D activity.

Patent Challenges and Litigation

Currently, there are no public records of litigation specific to patent 9,468,636. However, given its narrow claims and focus, possible future challenges may target:

  • Novelty: Based on prior art compounds with similar structures.
  • Obviousness: If modifications of prior art compounds are deemed predictable.

Summary of the Patent Landscape

Aspect Observation
Patent family size Moderate, with additional filings in key jurisdictions
Legal status Maintained, no public legal disputes yet
Competitive activity High, especially in CNS molecule registries and R&D pipelines

Key Takeaways

  • Patent 9,468,636 protects a specific chemical scaffold with narrow structural claims.
  • It covers various aspects: compound structures, synthesis methods, and therapeutic uses.
  • The scope is primarily limited to the defined compounds and their uses, with some room for design-around strategies.
  • The patent environment around these compounds is active, with multiple related filings and potential for future litigation.
  • The assignee is a key player in CNS drug development, with ongoing R&D efforts in neuropharmacology.

FAQs

1. How broad are the chemical claims of Patent 9,468,636?

They are narrow, covering specific chemical structures with defined substitutions, limiting patent scope to those compounds.

2. Can competitors develop similar compounds?

Yes, if they modify the chemical structure beyond the claims’ scope or use different synthetic methods.

3. Are there equivalent patents filed outside the US?

Yes, filings in Europe, Japan, and China exist, generally following the US priority date within 12 months.

4. Is the patent enforceable?

As of current public records, the patent remains active with no known legal disputes.

5. What are the main therapeutic applications?

Primarily focused on neurological and psychiatric conditions, especially CNS disorders.

References

  1. U.S. Patent and Trademark Office. (2016). Patent No. 9,468,636.
  2. PatentScope. (2016). Patent family and national filings overview.
  3. Thakur, S., & Bhutani, K. (2021). Recent trends in CNS drug patents. Journal of Patent Trends, 17(4), 22-35.

[1] U.S. Patent and Trademark Office (USPTO). (2016). Patent No. 9,468,636.

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Drugs Protected by US Patent 9,468,636

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 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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