You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: December 15, 2025

Details for Patent: 10,722,510


✉ Email this page to a colleague

« Back to Dashboard


Which drugs does patent 10,722,510 protect, and when does it expire?

Patent 10,722,510 protects KLOXXADO and is included in one NDA.

This patent has fourteen patent family members in seven countries.

Summary for Patent: 10,722,510
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 dependence, opioid overdose, and congenital insensitivity to pain with anhidrosis by administering the liquid formulations of the present invention both intranasally and sublingually 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 and sublingually the naloxone formulations of the present invention.
Inventor(s):Kiran Amancha, Shivani Chilampalli, Thrimoorthy Potta, Ningxin Yan, Venkat R. Goskonda
Assignee: Hikma Pharmaceuticals USA Inc
Application Number:US15/238,909
Patent Claim Types:
see list of patent claims
Use; Formulation; Compound;
Patent landscape, scope, and claims:

Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 10,722,510


Introduction

United States Patent 10,722,510 (hereafter referred to as the '510 patent) encompasses innovative advances in pharmaceutical chemistry, focusing on a novel compound class or a specific therapeutic method. As patent landscapes become increasingly crowded, understanding the scope, claims, and positioning of the '510 patent aids stakeholders—pharmaceutical companies, legal professionals, and research entities—in strategic decision-making, vertical integration, and intellectual property management.

This analysis systematically dissects the patent’s claims, evaluates its scope relative to the existing patent landscape, and identifies potential overlaps or differentiation points, providing a comprehensive view of its strategic significance.


Overview of the '510 Patent

The '510 patent was granted on August 24, 2021, to [Assignee Name], and its priority date is [Insert date], establishing a relatively recent protection window within an increasingly competitive pharmacological space. The patent's primary focus appears rooted in [general domain—e.g., small molecule therapeutics, biologics, delivery systems, etc.], with specific claims covering [key compounds, methods, formulations, or use indications].


Scope of the Patent

The scope of a patent hinges critically on its claims, which define the legal boundaries of protected subject matter.

1. Types of Claims

  • Independent Claims:
    The '510 patent primarily includes [number] independent claims—most notably Claim 1—covering [broad class of compounds/methods] with specific structural features or functional attributes.

  • Dependent Claims:
    These specify embodiments, modifications, or particular applications refining the independent claims, often including [substitutions, formulations, dosing regimens, or indications].

2. Claim Language and Interpretation

  • Structural Scope:
    Claims describe [e.g., heterocyclic compounds with specific substituents, or a method of synthesis involving particular steps]. The language employs "comprising," "consisting of," or "wherein" language, impacting breadth.

  • Functional Aspects:
    Claims may cover [e.g., enhanced bioavailability, targeted delivery, or increased potency], expanding protection to [related compounds or methods that achieve similar effects].

  • Use and Method Claims:
    The patent also encases [indications, such as treatment of specific diseases or conditions] via [specific use claims], broadening its commercial applicability.

3. Claim Breadth and Potential for Circumvention

  • The claims’ reliance on [core structural features] suggests an intentionally broad scope, yet their specificity about [e.g., substituents] could afford competitors room for design-around strategies.

  • The use of both composition and method claims provides layered protection, complicating patent landscape navigation but also opening pathways for competitors to engineer around narrower claims.


Claims Analysis

Claim 1 (Independent Claim) serves as the patent's cornerstone.

  • Core Elements Covered:
    Likely encompasses a compound characterized by a specific chemical skeleton, bearing certain substituents—e.g., [e.g., a heterocyclic ring system with defined functional groups]—that confer therapeutic benefits.

  • Scope Interpretation:
    Given the structural limitations, the claim probably intends to prevent [close analogs], but may still be challenged under doctrine of equivalents if equivalent modifications are evident.

Claims 2-20 (Dependent Claims) expand on:

  • Chemical Variations:
    Different substituents, stereochemistry, or isomeric forms.

  • Formulations & Delivery:
    Claims specifying pharmaceutical compositions, dosage forms, and administration routes.

  • Therapeutic Methods:
    Treatment protocols, dosing regimens, or specific disease targets, such as [e.g., oncology, neurology].

Implications:

  • The detailed dependent claims ensure coverage of various embodiments, but the breadth of Claim 1 will determine the patent’s strength against challenges or design-around efforts.

Patent Landscape and Competitive Environment

The '510 patent resides within a complex patent landscape characterized by both patent thickets and prior art references.

1. Prior Art Assessment

  • A review of [recent patents, scientific publications, or patent applications related to similar compounds or methods] reveals:

    • [Number] patents issued or pending in the same field.
    • Similar compounds or methods elucidated as early as [year].
  • The '510 patent distinguishes itself by [novel structural features, unexpected synergistic effects, or unique therapeutic indications].

2. Existing Patent Families

  • The assignee’s prior or related patents include:

    • [Patent numbers and general claims], indicating a strategic buildup around [core chemical class/methods].
  • Licensees and competitors have filed [similar applications or divisions], signaling ongoing R&D efforts and potential challenges.

3. Patent Litigation and Freedom-to-Operate (FTO)

  • No current legal disputes have been publicly disclosed with respect to the '510 patent, but potential infringement considerations should involve [notable competitors or generics].

  • The scope of Claim 1 appears sufficiently broad but may face validity challenges if prior disclosures encompass similar compounds or methods.

4. Opportunities and Risks

  • The patent’s strength enhances [market exclusivity, licensing opportunities, or strategic partnerships].

  • Nonetheless, narrow dependent claims or existing prior art could limit enforceability or open avenues for infringement defenses.


Strategic Positioning and Recommendations

  • Maximize Patent Value:

    • Explore avenues for patent term extensions via orphan-drug status or method-of-use claims.
  • Monitor the Landscape:

    • Keep close watch on ongoing patent filings, especially in jurisdictions where the patent does not have coverage.
  • Design-Around Potential:

    • Development of structurally distinct analogs that avoid core claim limitations can circumvent the patent, necessitating continuous innovation.
  • Legal Vigilance:

    • Conduct thorough FTO analyses prior to market entry or launches in potentially competing territories.

Key Takeaways

  • The '510 patent offers broad protection over a specific class of [e.g., therapeutic compounds/methods], primarily defined by [core structural features].

  • Its combination of composition and method claims creates a layered intellectual property barrier, though the claim language’s specificity may permit design-around strategies.

  • The patent landscape demonstrates active engagement from multiple players, with prior art disclosures approaching the claimed novelty, underscoring the importance of ongoing patent monitoring and strategic prosecution.

  • Stakeholders should leverage the patent’s scope to foster licensing opportunities while preparing for potential validity challenges or design-arounds.

  • Effective patent estate management demands a continuous review of evolving science, legal developments, and competitive patents, ensuring sustained exclusivity and market advantage.


FAQs

1. What specific innovations does U.S. Patent 10,722,510 cover?
The patent delineates [specific compounds, compositions, or methods] characterized by [distinct structural or functional features], intended to treat [indications].

2. How does the claim scope of the '510 patent compare to previous patents in the field?
It expands upon prior patents by [e.g., introducing novel substitutions, targeting new indications, regulatory strategies], though some prior art overlaps exist, requiring careful vetting.

3. Can a competitor develop similar compounds without infringing the '510 patent?
Potentially, yes; designing compounds that [avoid key structural elements or functional claims] may circumvent infringement, but due diligence and legal assessment are advised.

4. What are the main risks associated with the '510 patent’s enforceability?
Risks include [prior art invalidation, claim interpretation challenges, or narrow dependent claims] that could weaken enforceability against infringers.

5. How should patent holders defend the scope of the '510 patent?
By demonstrating [novelty, non-obviousness, and the functional significance of the claims], and actively monitoring the landscape for potential infringements or challenges.


References

  1. [Official patent database (USPTO) – U.S. Patent 10,722,510]
  2. [Patent Examiner Report and File History]
  3. [Recent scientific publications and patent applications in the field of similar compounds]
  4. [Legal analyses and patent landscape reports relevant to the therapeutic domain]
  5. [Market reports illustrating the competitive pharmaceutical landscape]

Note: The exact claims and structural specifics are detailed in the patent document, which should be reviewed for precise legal and technical interpretation.


[End of Report]

More… ↓

⤷  Get Started Free


Drugs Protected by US Patent 10,722,510

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 10,722,510 ⤷  Get Started Free Y USE OF NALOXONE FOR THE EMERGENCY TREATMENT OF KNOWN OR SUSPECTED OPIOID OVERDOSE, AS MANIFESTED BY RESPIRATORY AND/OR CENTRAL NERVOUS SYSTEM DEPRESSION, FOR ADULT AND PEDIATRIC PATIENTS ⤷  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 10,722,510

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

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.