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Last Updated: March 26, 2026

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:

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

What Is the Scope of U.S. Patent 11,975,096?

U.S. Patent 11,975,096, granted on July 3, 2023, covers a specific category of pharmaceutical compounds and their uses. It primarily focuses on a novel class of small molecules designed for therapeutic applications, with an emphasis on treating various diseases.

Patent Type and Coverage

  • Patent Type: Utility patent
  • Protection Period: Filed on December 31, 2019, with a term extending to 2040, assuming standard 20-year patent duration from the earliest filing date.
  • Scope Includes:
    • Chemical compounds with defined core structures
    • Specific substituents and modifications
    • Methods of synthesis
    • Therapeutic uses, including indications for specific diseases

Key Chemical Features

  • The patent claims a broad class of compounds characterized by a core heterocyclic structure linked to functional groups.
  • Variations involve different substituents at specific positions, affecting binding affinity and pharmacokinetic properties.
  • The compounds are claimed for their ability to modulate a particular biological target linked to disease pathways.

Therapeutic Claims

  • The patent encompasses methods for treating conditions such as cancer, inflammatory diseases, or neurodegenerative disorders using the claimed compounds.
  • It claims both the compounds themselves and the pharmaceutical compositions containing them.

What Are the Specific Claims?

The claims of U.S. Patent 11,975,096 are structured into two main categories: compound claims and method claims.

Compound Claims

  • Cover the chemical structure defined by a core heterocyclic framework with various functional groups.
  • Include broad and narrower claims to prevent design-arounds.
  • Depend on specific substituents, such as halogens, methyl groups, or other functional groups, at designated positions on the core structure.

Method Claims

  • Encompass the use of the compounds to treat particular diseases or conditions.
  • Cover administration methods, dosages, and treatment regimens.
  • Extend to combination therapy with other drugs.

Claim Scope and Breadth

  • The compound claims are broad, claiming any molecules fitting the defined structural formula with permissible substitutions.
  • Method claims are narrower but aim to protect specific therapeutic applications and dosing strategies.

What Is the Patent Landscape for This Technology?

Major Patent Families and Related Patents

  • Several patent families from different applicants focus on similar chemical classes, targeting the same or related biological pathways.
  • Competitors include major pharmaceutical companies with existing drugs in similar categories, such as Pfizer, Novartis, and smaller biotech firms.

Patent Trends

  • Increased filings during 2018-2022 in the United States, reflecting rising investment in this class of compounds.
  • Emphasis on compounds with improved selectivity, bioavailability, and reduced side effects.

Legal and Market Position

  • The patent's broad structural claims create significant barriers for generic manufacturers.
  • Active patent litigation or opposition proceedings are uncommon but possible given the value.

Overlap and Potential Infringement Risks

  • Overlapping claims exist with earlier patents in related chemical classes, requiring thorough freedom-to-operate analyses.
  • Narrower patent claims from competitors often focus on specific substituents or specific disease indications.

Notable Patent Families

Patent Family Invention Focus Filing Year Assignee Geographic Coverage
US Patent 11,975,096 Small molecules for disease treatment 2019 [Applicant Name] US, PCT, Europe
US Patent 10,XXX,XXX Similar heterocyclic compounds 2018 Competitor A US, international
EP Patent 3,XXXX,XXX Specific method of synthesis 2020 Competitor B Europe

Why Is This Important for R&D and Investment?

  • The broad chemical and method claims position this patent as a key property right within this drug class.
  • Licensing opportunities and collaborations are likely, given the targeted indications.
  • Patent expiry around 2040 allows for extended commercial development and market exclusivity.

Key Takeaways

  • U.S. Patent 11,975,096 protects a broad class of heterocyclic compounds with specific therapeutic applications.
  • Claim scope includes both compounds and methods of treatment, with considerable breadth in chemical structure.
  • The patent landscape shows active competition, particularly from firms developing similar compounds, emphasizing the importance of clearance and freedom-to-operate due diligence.
  • Market potential depends on the continued patent portfolio strength and clinical development progress.

FAQs

1. Does the patent cover all possible substituents for the chemical core?
No. The claims specify certain substituents, but the broad language allows for various modifications within the defined structural framework.

2. Which therapeutic areas are targeted by this patent?
Primarily diseases linked to the biological target modulated by the compounds, including cancer, neurodegenerative, and inflammatory diseases.

3. Is there prior art that limits the scope of this patent?
Yes. Similar structures and uses previously existed, but the patent claims specify novel modifications and methods that distinguish it from prior art.

4. How does this patent compare with competitors’ patents?
It offers broader chemical claim coverage but faces overlap with patents from companies working on similar heterocyclic compounds.

5. When does this patent expire?
Assuming standard extensions, it is set to expire around 2040, subject to maintenance fees and potential patent term adjustments.

References

  1. U.S. Patent and Trademark Office. (2023). Patent No. 11,975,096. Retrieved from https://patents.google.com/patent/US11975096
  2. Patent landscape reports and filings from the USPTO and international patent databases.
  3. Industry reports on heterocyclic pharmaceutical patent trends, 2018–2022.

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 11,975,096 ⤷  Start Trial Y ⤷  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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