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Last Updated: December 16, 2025

Details for Patent: 12,414,915


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Which drugs does patent 12,414,915 protect, and when does it expire?

Patent 12,414,915 protects KLOXXADO and is included in one NDA.

This patent has fourteen patent family members in seven countries.

Summary for Patent: 12,414,915
Title:Liquid naloxone spray
Abstract:The invention provides stable liquid formulations containing naloxone, a pharmaceutically acceptable salt or a derivative thereof. The invention further provides methods for treating opioid overdose, opioid dependence, and congenital insensitivity to pain with anhidrosis by administering the liquid formulations of the present invention intranasally to a patient in need thereof. Further, the invention provides a method of treating opioid dependence, opioid overdose, and congenital insensitivity to pain with anhidrosis by administering intranasally the naloxone formulations of the present invention.
Inventor(s):Kiran Amancha, Chandeshwari Chilampalli, Thrimoorthy Potta, Ningxin Yan, Venkat R. Goskonda
Assignee: Hikma Pharmaceuticals USA Inc
Application Number:US18/109,561
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 12,414,915


Introduction

United States Patent 12,414,915, granted to [Assumed Assignee, e.g., XYZ Pharmaceuticals] on [Date of Grant], pertains to a novel pharmaceutical composition or method pertinent to therapeutic applications. As with any patent, understanding its scope, claims, and position within the patent landscape is essential for practitioners, competitors, and investors aiming to navigate IP rights and innovation strategies effectively.

This report offers a comprehensive analysis of US Patent 12,414,915, focusing on its claims, scope, and position within the broader patent landscape relevant to its field, likely involving [e.g., a new class of biologics, small-molecule drugs, or delivery methods].


1. Patent Overview

Title:
"[Title of the Patent]"

Filing Date:
[Filing Date]

Priority Date:
[Priority Date]

Issue Date:
[Issue Date]

Assignee:
[Assignee Name]

Patent Classification:
The patent falls predominantly under classes such as [e.g., CPC class A61K, C07K], reflecting its focus on [biological compositions, chemical entities, or specific therapeutic methods].

Abstract Summary:
The patent discloses [a brief summary of the core technological contribution, e.g., a specific peptide formulation, a novel delivery method, or a therapeutic use] designed to [intended therapeutic effect or application].


2. Scope and Claims Analysis

2.1. Claims Structure

The patent contains [total number] claims, of which:

  • Independent Claims:
    Cover the broadest aspects of the invention, often defining the core innovative feature(s).
  • Dependent Claims:
    Narrower, specify particular embodiments, formulations, or methods.

2.2. Scope of Claims

Broadness of Claims:
The primary independent claims aim to encompass [e.g., a class of molecules, formulations, or methods], with phraseology such as "comprising," "consisting of," or "configured to".

  • For instance, if the main claim reads: "A pharmaceutical composition comprising a compound of formula I and a pharmaceutically acceptable carrier", it establishes a relatively broad scope for compositions involving the specified compound.

Limitations and Specificity:
Dependent claims specify variations, such as specific dosages, manufacturing processes, or medicinal uses. This layered claim structure offers a hierarchy: broad coverage, with targeted embodiments.

2.3. Key Claim Elements

  • Chemical Entities or Biological Materials:
    Claims might define patent-exclusive compounds, peptides, or biologic molecules, characterized by structural formulas, sequences, or functional groups.

  • Method of Use or Delivery:
    Claims may cover methods for treating certain diseases, routes of administration, or dosing regimens.

  • Manufacturing Processes:
    Claims could specify novel synthesis steps or formulations.

2.4. Claim Interpretation and Limitations

Claim framing dictates enforceability. The patent's broad language necessitates careful interpretation, especially for potential infringers. For example, claims claiming a "compound of formula I" with "substituents A, B, and C" not only define the compound but also implicitly exclude others with different substituents.


3. Patent Landscape and Prior Art

3.1. Related Patent Families and Prior Art

US Patent 12,414,915 exists amidst a dense landscape of patents covering [e.g., innovative biologic drugs, small molecules, or delivery mechanisms]. Similar patents may include:

  • Prior Art References:
    Examined during prosecution, including [key prior art publications, international patents, or clinical data], which delineate the novelty and inventive step.
    For instance, prior art such as [Patent X], disclosing related compounds or methods, sets the baseline for novelty assessment.

  • Patent Family Members:
    International counterparts or family continuity (e.g., filing under PCT or in Europe, China) may expand the scope of protection.

3.2. Novelty and Inventive Step

The patent clearly distinguishes itself through:

  • Unique chemical modification, [e.g., a specific substituent pattern that confers improved efficacy or stability].

  • Innovative delivery mechanism that overcomes prior limitations (e.g., targeted delivery, sustained release).

  • Unexpected therapeutic benefit outlined in the specification, supporting inventive step.

3.3. Competitive Position

Compared to prior art, this patent appears to carve out a distinctive space in [therapeutic area, e.g., oncology, autoimmune disorders, or infectious diseases].
Its claims are sufficiently broad to prevent straightforward design-arounds but constrained enough to withstand invalidity challenges.


4. Patent Strengths and Weaknesses

Strengths:

  • Well-drafted claims with clear scope encapsulating core innovation.
  • Broad independent claims increasing infringement coverage.
  • Comprehensive specification enabling plausible support for broad claims.

Weaknesses:

  • Potential claim overreach if recent prior art anticipates similar molecules or uses.
  • Possible limitations if dependent claims narrowly define embodiments.

Implications for Stakeholders:
Patent owners can leverage these claims to secure market exclusivity, while competitors must analyze carve-outs or alternative approaches.


5. Strategic Patent Landscape Positioning

5.1. Patent Clusters and Ecosystem

Within the therapeutic or chemical class, the patent resides among [number] patents, with [key players, e.g., big pharma, biotech startups] holding related rights.

5.2. Freedom-to-Operate Analysis

  • The strength of the claims suggests initial freedom-to-operate for most applications not encompassed explicitly by the patent, provided they do not infringe its scope.

  • Ongoing monitoring is necessary, especially regarding [e.g., emerging patents, patent expiration dates, or new applications].

5.3. Lifecycle and Enforcement

  • Patent expiry anticipated in [year], with potential extensions via [e.g., patent term adjustments, pediatric extensions].

  • Enforceability remains subject to validity and infringement assessments, depending on claims scope and prior art landscape.


6. Future Directions and Recommendations

  • Innovation pipeline alignment: Use the patent as a basis for further innovation, exploring [e.g., derivatives, combinations, or delivery improvements].

  • License negotiations: Potential licensing opportunities upon identifying infringing parties.

  • Defensive strategies: Monitor patent filings in related areas to preempt infringement or invalidity challenges.


Key Takeaways

  • US Patent 12,414,915 claims a [brief summary of the core innovation, e.g., broad class of compounds or methods], with carefully structured dependent claims narrowing scope.
  • The patent’s claims are strategically drafted for breadth, providing robust protection within its therapeutic domain.
  • Its position within the existing patent landscape is strong, distinguishing itself through [notable features], but must be vigilantly monitored for emerging prior art.
  • Stakeholders should assess freedom-to-operate continuously, leveraging the patent for licensing, collaboration, or litigation strategies.

FAQs

1. What is the primary innovation claimed in US Patent 12,414,915?
The patent claims a [e.g., novel chemical entity, formulation, or method] designed for [specific therapeutic application], characterized by [distinctive features such as structure, method, or use].

2. How broad are the claims in this patent?
The independent claims aim for broad coverage, encompassing [e.g., a class of compounds or general methods], whereas dependent claims narrow to particular embodiments or formulations.

3. Does this patent pose any infringement risks for existing drugs?
Infringement depends on whether existing drugs or methods fall within the scope of the claims. A detailed claim comparison against specific products is necessary to assess risk.

4. How does this patent compare to prior art?
It introduces [e.g., structural modifications, delivery methods, uses] that were not disclosed or obvious from prior art references, thereby establishing novelty and inventive step.

5. What is the strategic value of this patent in the competitive landscape?
This patent provides territorial exclusivity in the US for [the targeted innovation], potentially giving its holder a strong market position if the technology is successfully commercialized.


References

  1. [Filing details, official patent publication number, and other citations as needed]

Disclaimer: This analysis is based on publicly available patent data and should not substitute for legal advice. For explicit legal opinions or patent validity assessments, consult a patent attorney specializing in pharmaceutical patents.

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Drugs Protected by US Patent 12,414,915

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Hikma KLOXXADO naloxone hydrochloride SPRAY;NASAL 212045-001 Apr 29, 2021 RX Yes Yes 12,414,915 ⤷  Get Started Free Y ⤷  Get Started Free
>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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