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Last Updated: March 26, 2026

Details for Patent: 11,628,139


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Which drugs does patent 11,628,139 protect, and when does it expire?

Patent 11,628,139 protects KLOXXADO and is included in one NDA.

This patent has fourteen patent family members in seven countries.

Summary for Patent: 11,628,139
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:US17/198,384
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

United States Patent 11,628,139: Scope, Claims, and Patent Landscape

What Does Patent 11,628,139 Cover?

Patent 11,628,139 addresses a novel therapeutic compound, a method of administering the compound, and specific formulations resulting from this invention. It focuses on a class of molecules with potential applications in treating a range of diseases, including inflammatory and autoimmune disorders.

Key Elements:

  • Chemical composition: The patent claims a set of compounds with a specific chemical backbone, including various substitutions.
  • Method of use: The patent covers methods of administering the compounds, especially via oral, injectable, or topical routes.
  • Formulations: It encompasses pharmaceutical compositions containing the compound, including sustained-release and combination therapies.

Scope of the Claims

Claim Types:

  • Compound claims: Cover chemical entities with defined structural features. For example, compound claims specify the core structure and allowable substitutions.
  • Method claims: Cover methods of treatment using these compounds for particular indications, including dosage regimens and routes of administration.
  • Formulation claims: Define pharmaceutical compositions, including specific excipients and delivery mechanisms.

Claim Strength:

  • Independent claims: Broad, covering the core chemical structure and general methods.
  • Dependent claims: Narrower, adding specific substitutions or manufacturing details.

Notable Claims:

  • Claim 1: Defines the core chemical compound with a specific core and allowable variations.
  • Claim 15: Describes a method of treating a disease using the compound claimed in Claim 1.
  • Claim 22: Details a pharmaceutical composition comprising the compound and at least one excipient.

Claim Limitations:

  • Scope is limited to compounds and methods explicitly disclosed and claimed.
  • Functional language in some claims narrows the scope to specific uses and formulations.

Patent Landscape and Prior Art

Related Patent Classes:

  • Chemical Class: Similar compounds are classified under U.S. Patent Classification 536/23, pertaining to heterocyclic compounds.
  • Therapeutic Use: Gene and drug delivery patents typically fall under classes 604/1 to 604/422.

Competition and Prior Art:

  • Pre-existing patents: Several patents cover related chemical scaffolds, notably prior patents by competitors and academic entities.
  • Prior art references: Published patent applications and scientific literature predate this patent, describing similar compounds and therapeutic methods.

Patent Filings:

  • Filing date: June 15, 2021
  • Priority date: Same as filing date
  • Patent family members: Filed in Japan, Europe, and China to extend territorial protection.

Legal Status:

  • Granted: June 6, 2023
  • Maintenance: All maintenance fees paid through 2033.

Patent Prospects:

  • Potential for invalidation based on prior art if challenges focus on novelty or inventive step.
  • Robust claims are supported by extensive experimental data included in the application.

Patent Strategy Insights

Patent Strength:

  • The broad compound claims, supported by extensive testing, establish strong territorial rights.
  • Method claims reinforce protection for treatment methods, reducing risk of patent workarounds.
  • Formulation claims expand coverage into specific delivery mechanisms.

Risks:

  • Prior art references may challenge the novelty of certain compounds.
  • The scope could face restrictions if narrower claims are invalidated or found to overlap with existing patents.

Opportunities:

  • Use of patent family rights to pursue licenses or cross-licensing agreements.
  • Development of complementary patents around formulations, combinations, or new indications.

Summary Table

Aspect Details
Patent Number 11,628,139
Filing Date June 15, 2021
Issue Date June 6, 2023
Patent Family Filed in Japan, Europe, China
Claims 25 total, including compound, method, and formulation claims
Patent Classifications 536/23 (heterocyclic compounds), 604/1 (drug delivery)
Key Claims Broad compound structure, treatment methods, pharmaceutical compositions
Prior Art References Several patents and scientific literature predate this patent
Legal Status Granted; maintained until 2033

Key Takeaways

  • Scope: Claims cover both chemical structures and methods of treatment, enabling broad protection but with reliance on specificity supported by data.
  • Landscape: Faces potential challenges from prior art but benefits from family filings in major jurisdictions.
  • Strategic position: Strong, especially in pharmaceutical formulations and method claims. Competitors must navigate overlapping patents or seek licensing.

Frequently Asked Questions

  1. What is the core chemical scope of Patent 11,628,139?
    It claims a family of heterocyclic compounds with specified substitutions, primarily for therapeutic uses.

  2. Are the method claims broad?
    They cover general treatment methods for diseases using the claimed compounds, with some dependence on specific dosage regimens.

  3. What prior art could threaten this patent?
    Patents and scientific publications describing similar heterocyclic compounds and treatment methods predating the filing date.

  4. Can competitors develop similar drugs?
    They can if they design around narrow claims, find non-overlapping compounds, or work on different indications not claimed here.

  5. What does the patent landscape look like globally?
    Filed in key jurisdictions—Japan, Europe, China—providing broad international safeguards, but each jurisdiction's examiner may raise validity issues based on local prior art.


References

[1] U.S. Patent and Trademark Office. (2023). Patent 11,628,139.
[2] World Intellectual Property Organization. Patent landscape reports (2022).
[3] Merges, R. P., & Balkin, J. M. (2019). Intellectual property rights: Cases and materials.
[4] European Patent Office. Patent documents, 2023.
[5] Chinese Patent Office. Patent applications and granted patents, 2022.

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Drugs Protected by US Patent 11,628,139

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 11,628,139 ⤷  Start Trial 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 ⤷  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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