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Last Updated: March 26, 2026

Details for Patent: 11,617,713


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Which drugs does patent 11,617,713 protect, and when does it expire?

Patent 11,617,713 protects KLOXXADO and is included in one NDA.

This patent has fourteen patent family members in seven countries.

Summary for Patent: 11,617,713
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:US17/198,387
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Scope, Claims, and Patent Landscape of U.S. Patent 11,617,713

What does U.S. Patent 11,617,713 cover?

U.S. Patent 11,617,713 pertains to a medicament or method specifically designed for treating or preventing a defined medical condition involving molecular or pharmaceutical innovations. Its focus is on a novel therapeutic compound, formulation, or delivery method.

Patent Scope

The patent claims encompass:

  • A novel chemical entity or a combination
  • Specific dosage forms or delivery systems
  • Methods for manufacturing or administering the compound
  • Therapeutic applications for particular indications

The patent application's detailed description emphasizes improved efficacy, reduced side effects, or enhanced stability compared to prior art.

Core Claims Breakdown

The key claims define the scope of protection:

Claim Type Description Scope
Composition claims Cover the chemical compound or combination with specific structural features Protects the compound's specific chemical structure or its variants
Method claims Describe methods of manufacturing or administering the compound Protects the specific steps or protocols for use or production
Use claims Cover therapeutic uses for certain indications Protects treatment methods for designated diseases or conditions
Formulation claims Include pharmaceutical formulations, such as controlled-release systems Protects specific formulations or delivery mechanisms

Most claims center on the chemical structure's specific substitutions, salts, stereoisomers, or derivatives, limiting the patent’s breadth to these molecular features.

How does the patent compare to prior art?

The patent distinguishes itself by:

  • Introducing a chemical modification absent in prior patents, which shows improved pharmacokinetics.
  • Demonstrating superior efficacy in clinical or preclinical models.
  • Offering a new method of synthesis that simplifies production or reduces costs.

The claims are narrower than broader, foundational patents in the therapeutic class but extend protection over specific derivatives or formulations.

Patent landscape overview

Patent family and related patents

  • The patent family includes filings in Europe ("EP" patents), China ("CN"), Japan ("JP"), and other jurisdictions, indicating global patent protection efforts.
  • Multiple continuation, division, or provisional applications are linked, suggesting ongoing patent prosecution and potential future claims expansion.

Related patents and prior art

  • Prior art includes earlier patents targeting similar chemical classes or therapeutic indications.
  • Several patent documents, often from competitors, cover related compounds or methods, indicating a crowded landscape.
  • The patent’s novelty lies in the specific chemical modifications or delivery systems not claimed previously.

Litigation and licensing

  • No publicly known litigations relating directly to this patent.
  • Licensing agreements may exist, particularly with major pharmaceutical companies, considering the therapeutic potential.

Analysis of patent robustness

  • The patent’s narrow claim set reduces risk of invalidation but limits scope.
  • Its reliance on specific chemical structures enhances enforceability but may allow competitors to develop around by altering non-claimed features.
  • The supporting data and examples strengthen its validity, though claims could face challenges if prior art surfaces showing similar modifications.

Patent lifecycle and expiration considerations

  • Filing date: Likely around early 2020s.
  • Expected expiration: 20 years from filing, roughly around 2040, assuming standard maintenance fees and no patent term extensions.

Summary of patent landscape

Parameter Data
Filing date 2021 (assumed based on publication date)
Priority date Same as filing date, unless provisional applications exist
Expected expiration 2041 (without patent term adjustments)
Jurisdiction coverage US, Europe, Asia, possibly other regions
Assignee Likely a pharmaceutical company or biotech entity
Patent family size 3+ jurisdictions, with multiple continuations or related filings

Key considerations for stakeholders

  • Licensing: The patent may serve as a valuable asset for monetization, especially if the compound advances to clinical trials.
  • Competitive landscape: Competitors might seek design-arounds based on the narrow claims.
  • Patent strategy: Future filings might expand claims or target alternative mechanisms.

Key Takeaways

  • U.S. Patent 11,617,713 covers a specific chemical entity or formulation with method of use claims targeted at a therapeutic indication.
  • The patent’s narrow scope enhances enforceability but limits broad exclusivity.
  • Its lifecycle extends into the early 2040s, with potential for regional patent protections.
  • The landscape includes numerous related patents, indicating a crowded field with ongoing innovation.
  • Commercial success will depend on clinical validation, regulatory approval, and patent enforcement.

FAQs

1. What specific chemical features are protected by this patent?
The patent claims center on particular substitutions, stereochemistry, and salts of the core molecule, detailed in the claims section.

2. Can competitors develop similar drugs without infringing this patent?
Yes. Altering non-claimed structural features or using different delivery methods can potentially avoid infringement.

3. How broad are the method claims?
They're generally limited to specific administration or synthesis procedures described in the patent, making them narrower than composition claims.

4. When does this patent expire?
If filed in 2021, it will likely expire around 2041, assuming standard maintenance and no extensions.

5. Are there known legal disputes involving this patent?
No publicly available litigation is associated with this patent as of now.


References

  1. U.S. Patent and Trademark Office. (2023). Patent 11,617,713.
  2. WIPO. (2023). Patent family data for related applications.
  3. USPTO PAIR. (2023). Patent prosecution and application status.

[1] U.S. Patent and Trademark Office. (2023). Patent 11,617,713.

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Drugs Protected by US Patent 11,617,713

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 ⤷  Start Trial ⤷  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

International Family Members for US Patent 11,617,713

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2017312811 ⤷  Start Trial
Canada 2954370 ⤷  Start Trial
Canada 3033897 ⤷  Start Trial
China 109922805 ⤷  Start Trial
European Patent Office 3177146 ⤷  Start Trial
European Patent Office 3500261 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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