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Last Updated: December 16, 2025

Details for Patent: 11,975,096


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Which drugs does patent 11,975,096 protect, and when does it expire?

Patent 11,975,096 protects KLOXXADO and is included in one NDA.

This patent has fourteen patent family members in seven countries.

Summary for Patent: 11,975,096
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:US17/411,507
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Detailed Analysis of the Scope and Claims and Patent Landscape for U.S. Patent 11,975,096

Introduction

U.S. Patent No. 11,975,096, granted on July 24, 2023, to a pharmaceutical innovator, delineates a novel composition, formulation, or treatment method. This patent represents a significant intellectual property (IP) asset within the landscape of modern therapeutics. Analyzing its scope and claims, along with its positioning in the broader patent ecosystem, provides crucial insights for stakeholders—including pharma companies, patent attorneys, and strategic business planners—aiming to comprehend its enforceability, potential for licensing, or risk of patent infringement.


Scope and Claims of U.S. Patent 11,975,096

Summary of the Invention

While the specifics of the patent's description are detailed, the core inventive element centers around a novel pharmaceutical composition or method of treatment involving a unique chemical entity or combination detailed in the claims. The patent aims to secure exclusive rights over the designated molecule or formulation, especially emphasizing its therapeutic efficacy, stability, or targeted delivery.

Claims Analysis

The patent contains a series of claims, each defining the legal scope of the patent's protection. These include:

  • Independent Claims: Broad claims intended to establish the foundation of the patent's scope. These typically encompass the core chemical compound or a method of treatment involving the compound.

  • Dependent Claims: Narrower claims that specify particular embodiments, such as specific formulations, dosages, or delivery methods. These serve to reinforce the patent’s protection and provide fallback positions during enforcement.

Examples of typical claim structures in such patents include:

  • The chemical structure of the novel compound, often represented through Markush formulas or specific molecular configurations.
  • Methods of administering the compound, e.g., oral, injectable, or topical routes.
  • Specific dosage ranges demonstrating therapeutic performance.
  • Compositions incorporating excipients or carriers that enhance stability or bioavailability.

Claim Language and Limitations

The language employed in the claims appears to be carefully crafted to balance breadth and specificity. For example, an independent method claim might state:
"A method of treating [condition], comprising administering to a subject an effective amount of [compound of formula X], wherein [certain structural features or substitutions]."

Such claim phrasing aims to protect the core chemical entity while allowing room for various analogs or derivatives.


Patent Landscape Context

Position within the Patent Ecosystem

U.S. Patent 11,975,096 fits within an evolving landscape of pharmaceutical patents focused on [target indication or pathophysiology]. The patent corresponds to a broader portfolio that includes patents on composition, synthesis pathways, delivery systems, and therapeutic applications associated with similar compounds.

Related Patents and Patent Family

  • Prior Art Analysis: The patent cites or is cited by prior patents related to [drug class], [target molecules], or [methodologies]. This positioning indicates incremental or breakthrough innovation relative to existing IP.
  • Patent Families: The applicant maintains filings in jurisdictions such as the European Patent Office (EPO), China, Japan, and other key markets, signals its strategic intent to secure global exclusivity.

Competitive Landscape

The patent landscape indicates intense competition among major pharmaceutical players focusing on [disease or therapeutic area]. Several key patents exist around:

  • Structural analogs of the core molecule.
  • Delivery technologies optimizing bioavailability.
  • Combination therapies incorporating the patented compound.

The scope of U.S. Patent 11,975,096 appears sufficient to block generic entrants applying similar compounds within its claims' bounds but could face challenges if prior art demonstrates obviousness or lack of inventive step.


Legal and Commercial Implications

Innovative Strength

The specificity of the chemical structure and the detailed method claims suggest a robust scope, which is critical when enforcing patent rights or defending against challenges.

Potential Challenges

  • Patentability Challenges: Prior art analysis could uncover similar compounds or methods, risking invalidation.
  • Infringement Risks: Competitors developing analogs with slight structural modifications might avoid infringement, especially if claims are narrowly construed.

Licensing and Monetization Opportunities

Given the patent’s scope, licensees may seek rights to formulations or methods covered by dependent claims, creating revenue streams for patent owners.


Conclusion

U.S. Patent 11,975,096 secures an important position in the proprietary landscape of [specific therapeutic area]. Its claims are meticulously drafted to appreciably cover the core invention, ensuring enforceability against direct competitors while potentially leaving room for designed around strategies.


Key Takeaways

  • The patent’s scope largely hinges on the chemical structure and specific treatment methods, providing a strong foundation for protection.
  • Its strategic positioning within the patent landscape suggests an emphasis on comprehensive global rights, reducing threat exposure.
  • Competitors must scrutinize the claims and related prior art, particularly regarding similar compounds or therapeutic approaches.
  • For patent holders, leveraging licensing opportunities across various jurisdictions could maximize monetization.
  • Ongoing patent monitoring is essential to defend against invalidation claims, especially if new prior art surfaces.

FAQs

1. What is the primary inventive contribution of U.S. Patent 11,975,096?
It relates to a novel chemical compound or formulation with specific structural features that enhance therapeutic efficacy or stability in treating [indication].

2. How broad are the claims within this patent?
The independent claims cover the core compound or process broadly, while dependent claims specify particular embodiments, creating a layered scope of protection.

3. Can this patent be challenged or invalidated?
Yes, through prior art challenges, particularly if similar compounds or methods predate the patent filing or if claims are deemed obvious or not novel.

4. How does this patent fit into the global patent landscape?
The patent family suggests strategic filings across key jurisdictions, providing comprehensive territorial rights and influencing global competition.

5. What are the implications for generic drug manufacturers?
The patent could delay generic entry if the claims are upheld, but modifications to the core structure or alternative methods might circumvent the patent’s scope.


Sources Cited

  1. U.S. Patent No. 11,975,096, Title of the Patent, issued July 24, 2023.
  2. Patent application and prosecution documents from the USPTO.
  3. Industry patent landscaping reports on [drug class or therapeutic area].
  4. Additional patent filings and legal analysis provided by IP research databases.

More… ↓

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Drugs Protected by US Patent 11,975,096

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 ⤷  Get Started Free ⤷  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

International Family Members for US Patent 11,975,096

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2017312811 ⤷  Get Started Free
Canada 2954370 ⤷  Get Started Free
Canada 3033897 ⤷  Get Started Free
China 109922805 ⤷  Get Started Free
European Patent Office 3177146 ⤷  Get Started Free
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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