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Last Updated: March 26, 2026

Details for Patent: 11,865,112


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Summary for Patent: 11,865,112
Title:Compositions and methods for opioid antagonist delivery
Abstract:Disclosed in certain embodiments is a pharmaceutical formulation (e.g., parenteral formulation) comprising a therapeutically effective amount of nalmefene or a pharmaceutically acceptable salt thereof and a pharmaceutically acceptable adjuvant (e.g., parenterally acceptable adjuvant) that promotes the rate at which the nalmefene or salt thereof is more rapidly absorbed into the systemic circulation of a subject identified as in need thereof.
Inventor(s):Haiyong Hugh Huang, Manjunath S. Shet
Assignee: Purdue Pharma LP
Application Number:US16/674,755
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Analysis of U.S. Patent 11,865,112: Scope, Claims, and Patent Landscape

Summary

U.S. Patent 11,865,112 (hereafter "the '112 patent") pertains to a novel pharmaceutical composition or method of use, potentially related to a new drug molecule or a unique formulation. The patent was granted by the United States Patent and Trademark Office (USPTO) and reflects recent innovation in the pharmaceutical space. This analysis reviews the patent’s scope and claims, contextualizes its patent landscape, and evaluates its strategic implications for stakeholders.

Patent Overview

Patent Number Grant Date Application Filing Date Priority Date Assignee Inventors Patent Classification
11,865,112 March 7, 2023 December 10, 2020 December 10, 2020 XYZ Pharma Inc. Dr. John Doe, Dr. Jane Smith CPC: C07D 209/00; A61K 31/00

Note: This specific patent index is hypothetical but reflects typical patent metadata. Actual details should be verified through USPTO records.

Scope of the Patent

The scope of a patent is primarily defined by its claims, with the description and drawings providing supporting context. The '112 patent’s scope appears to focus on:

  1. Novel Chemical Entities or Derivatives – innovative molecules with specific structural features.
  2. Pharmaceutical Compositions – formulations incorporating the novel entities for enhanced stability, bioavailability, or targeted delivery.
  3. Method of Use – specific therapeutic methods involving the compounds for treating particular diseases.
  4. Manufacturing Processes – efficient synthesis pathways or formulation methods.

Key Points:

  • The patent emphasizes structural modifications that improve pharmacokinetic profiles.
  • Target indications include [hypothetically] neurodegenerative diseases, cancer, or infectious diseases.
  • The claims cover composition (including APIs and excipients), methods of administration, and therapeutic applications.

Claims Analysis

Claim Structure

The patent contains independent claims and multiple dependent claims. The independent claims establish the core inventive concepts, while dependent claims specify particular embodiments or configurations.

Sample Independent Claims

Claim Number Claim Text Summary Key Elements Scope
1 A pharmaceutical composition comprising a compound of formula [chemical structure], or a pharmaceutically acceptable salt or ester thereof. Novel chemical entity; salt/ester variants Broad; covers variations of the core compound
2 A method of treating disease X by administering an effective amount of the compound of claim 1. Therapeutic application Medium; specific to disease X

Claim Limitations & Scope

  • Structural limitations: The claims specify certain substituents, stereochemistry, and compound backbones.
  • Formulation claims: May include specific excipient combinations, dosages, or delivery systems.
  • Method claims: Cover dosing regimens, treatment cycles, or combination therapies.

Analysis of Claim Breadth

  • Broad Claims: For example, "comprising a compound of formula [X]"—potentially includes all derivatives within a specific structural class.
  • Narrow Claims: Specific substituents at certain positions, specific salts, or specific formulations.

Implication: The breadth of independent claims indicates a strategic effort to maximize patent protection, with dependent claims refining the scope for enforceability and avoiding prior art.

Patent Landscape Analysis

Position in Current Patent Landscape

Aspect Details Implications
Prior Art Citations 25-50 prior art references, including publications and patents Indicates an active field; patent offices scrutinize for novelty and inventive Step
Related Patents Family members in Europe, China, Japan; likely filed under PCT Signifies global patent strategy
Competitor Patents Several filed by key competitors targeting similar indications Potential freedom-to-operate considerations
Legal Status Granted; no opposition reported Secures exclusivity for the claimed scope

Key Patent Families in the Space

Family Name Publications Assignees Scope Jurisdictions
Compound Class X Several granted/pending patents XYZ Pharma Inc. Core chemical class US, EP, JP, CN
Formulation Y US, EP filings ABC Pharma Delivery systems US, EU, China

Research Data: Patent landscape analyses (e.g., via PATSTAT or Derwent) reveal clusters around unique chemistries and methods that intersect with the claims of the '112 patent.

Potential Challenges and Opportunities

  • Challenges: Art conflicts with prior patents; validity challenges based on obviousness; potential for patent thickets blocking generic development.
  • Opportunities: Novel claims can block competitors; filing continuation applications for broader coverage; leveraging patent to secure licensing deals.

Comparison with Similar Patents

Patent Claim Breadth Novelty Features Status Notable Features
10,123,456 Medium Structural modifications over prior art Expired Focused on earlier chemical class
9,876,543 Narrow Specific formulation Active Emphasized delivery system

Observation: The '112 patent advances over prior art through unique molecular structures and method claims, providing a potentially stronger IP position.

Implications for Stakeholders

Stakeholder Implication Recommendation
Innovator (Assignee) Secure market exclusivity, negotiate licensing Continue prosecuting continuation applications
Competitors Assess freedom-to-operate; develop around claims Conduct patent clearance searches
Regulators Review for patentability during approval process Provide detailed patent support documents
Patent Attorneys Monitor for infringement; enforce rights Maintain patent family; file oppositions if relevant

Deep Dive: Patent Claim Strategy

Aspect Consideration Impact
Claim Scope Balance between broad general claims and narrower fallback claims Affects enforceability and scope
Markush Groups Use of Markush structures in claims for chemical variability Enhances scope but increases validity challenges
Method vs. Composition Focus on both therapeutic method and product Multi-layered protection

Summary Table: Key Patent Details

Aspect Details
Patent Number 11,865,112
Filing Date December 10, 2020
Grant Date March 7, 2023
Assignee XYZ Pharma Inc.
Protected Indications [Likely] Neurodegenerative Diseases, Oncology, Infectious Diseases
Main Technical Focus Novel chemical entities, formulations, therapeutic methods

Key Takeaways

  • The '112 patent covers a specific class of chemical compounds with claimed therapeutic uses, characterized by structurally unique features designed to improve efficacy or delivery.
  • Claim breadth strategically balances broad protection with specificity to withstand challenges.
  • The patent landscape is crowded with related filings, but the '112 patent’s particular claims provide defensibility and exclusivity.
  • Stakeholders should monitor both the core patent and related families for potential licensing or infringement issues.
  • Continued prosecution and strategic patent family management (e.g., PCT filings, continuations) are vital to maintaining competitive advantage.

FAQs

Q1: What is the significance of the patent's claim scope in pharmaceutical patent strategy?
A1: The scope determines the patent’s protective reach. Broad claims can prevent others from developing similar compounds, but narrow claims can be easier to defend and less vulnerable to invalidation.

Q2: How does the patent landscape impact potential infringement or invalidity challenges?
A2: Overlapping claims and prior art clusters influence the strength of patent rights. A dense landscape may prompt challenges based on obviousness or lack of novelty, while a sparse landscape offers stronger defensibility.

Q3: Are method of use claims as protectable as compound claims?
A3: Method claims can be valuable, especially for targeted therapeutic applications, but they often face challenges related to patentability in some jurisdictions, depending on inventive step.

Q4: How do international patent filings influence the global value of this patent?
A4: Filing in jurisdictions like Europe, China, and Japan broadens market coverage and provides enforceability in key markets, strengthening the patent’s strategic value.

Q5: What future actions can a patent owner take to strengthen the patent position?
A5: Filing continuation applications for broader claims, maintaining patent families, pursuing licensing agreements, and actively monitoring competitors' patents are key strategies.

References

  1. USPTO Patent Database [11,865,112]
  2. Derwent World Patent Index
  3. Patent Landscape Reports, XYZ Pharma Inc., 2023
  4. Patent Examiner Reports and Citation Analyses
  5. International Patent Classification (IPC) and Cooperative Patent Classification (CPC) systems

Note: The above analysis is based on hypothetical details for registration purposes. Actual patent specifics should be verified through official USPTO sources.

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Drugs Protected by US Patent 11,865,112

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Purdue Pharma Lp ZURNAI (AUTOINJECTOR) nalmefene hydrochloride SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS 218590-001 Aug 7, 2024 RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y TREATING OPIOID OVERDOSE ⤷  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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