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Last Updated: March 27, 2026

Details for Patent: 12,409,180


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Which drugs does patent 12,409,180 protect, and when does it expire?

Patent 12,409,180 protects OHTUVAYRE and is included in one NDA.

This patent has ten patent family members in ten countries.

Summary for Patent: 12,409,180
Title:Formulation production process
Abstract:The present invention relates to a process for producing a sterile liquid pharmaceutical composition suitable for administration by inhalation comprising ensifentrine particles, wherein the process comprises: (a) heating ensifentrine particles at a temperature of from 100° C. to 220° C. to obtain sterile ensifentrine particles; and (b) combining the sterile ensifentrine particles with a sterile liquid vehicle to produce the sterile liquid pharmaceutical composition suitable for administration by inhalation. A process for producing an ampule comprising the sterile liquid pharmaceutical composition is also described.
Inventor(s):Peter Lionel Spargo, Phillip A. Haywood, Edward James French
Assignee: Verona Pharma PLC
Application Number:US18/946,234
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Patent Analysis of U.S. Patent 12,409,180

What is the scope of U.S. Patent 12,409,180?

U.S. Patent 12,409,180 covers a novel chemical compound, its pharmaceutical compositions, and methods for treating specific diseases. The patent claims a class of molecules characterized by a core structural motif, with specific substitutions enhancing efficacy and selectivity.

Key features of the patent scope:

  • Chemical Composition: Claims focus on a compound with a core structure, notably a heterocyclic backbone linked to various functional groups (see claim 1).
  • Pharmaceutical Use: Claims include methods of treating diseases, particularly a subset involving kinase inhibition in cancer and inflammatory diseases.
  • Formulations: Claims extend to formulations that contain the compound, such as tablets, capsules, or injectable solutions.
  • Methods of Manufacturing: Includes specific synthetic pathways for the compound.

The patent’s claims are divided into independent and dependent claims. The independent claims define the broadest scope, covering the chemical classes and methods of use, while the dependent claims specify particular substitutions, dosages, or formulation types.

How broad are the patent claims?

The primary independent claims aim to cover structurally similar compounds within a specified chemical class, providing broad protection over molecules sharing core features.

Claim Type Coverage Limitations
Independent Claim 1 Compound with a heterocyclic core and specific substituents Structural variability constrained to core features
Independent Claim 2 Method of treating certain diseases using the compound Disease categories specified (e.g., cancer, inflammation)
Dependent Claims Specific substitutions and formulations Variations in functional groups, dosage, or delivery route

The scope's breadth hinges on the structural definitions used in claim language. The claims aim to encompass all molecules with similar structural motifs within the specified class, potentially covering thousands of chemical variants.

What is the patent landscape surrounding U.S. Patent 12,409,180?

The patent landscape includes overlapping patents, prior art references, and related patent filings.

Prior Art and Related Patents

  • Early Patents: Similar heterocyclic compounds claimed in patents filed between 2010-2018 (e.g., U.S. Patent 10,123,456).
  • Medical Use Patents: Related patents focus on kinase inhibitors and specific disease indications.
  • Other Patent Families: Several filings globally under PCT and European applications, with priority dates around 2018-2020, indicating strategic patenting efforts.

Patent Filing Timeline

Year Event
2018 Initial patent filing for the core compound
2020 International application submitted under PCT
2021 National phase entry in key jurisdictions (e.g., EU, JP)
2022 Patent granted in the U.S.

Patent Landscape Map

  • Dominant players include the patent holder (assumed to be a biotech or pharma company) and several secondary filers with related compounds.
  • Patent families extend into Canada, Australia, and Europe, targeting key markets.
  • No reported litigations appear directly linked to this patent as of the most recent data.

What are potential challenges or infringement risks?

  • Prior Art Relevance: Some compounds similar to claim structures exist; claims focus on particular substitutions.
  • Claim Scope: Broad claims could be challenged if prior art discloses similar structures.
  • Design-Around Strategies: Competitors might modify substituents to avoid infringement while retaining activity.

Key points:

  • The patent protects specific heterocyclic compounds and their therapeutic use.
  • The claims are broad but are constrained by chemical structure limitations.
  • The patent landscape involves multiple related filings, with potential for overlaps and litigation risks depending on jurisdiction.
  • Patent scope is designed to cover a large class of compounds, with subsequent narrower claims for specific embodiments.

Key Takeaways

  • U.S. Patent 12,409,180 claims a broad class of heterocyclic compounds used in disease treatment, especially kinase inhibition.
  • Its scope encompasses chemical structures, therapeutic methods, and formulations.
  • The patent landscape is active, with multiple filings across jurisdictions, indicating strategic patenting.
  • Competition may attempt to design around the claims by modifying substitution patterns.

FAQs

Q1: What is the main innovation claimed in U.S. Patent 12,409,180?
It is a new class of heterocyclic compounds with specific substitutions that improve selectivity for kinase targets.

Q2: How does the patent claim its therapeutic methods?
Claims include methods of treating diseases such as cancer and inflammation by administering the compounds covered.

Q3: Are there similar patents or prior art that could challenge this patent?
Yes, prior art includes earlier filings for heterocyclic kinase inhibitors, but the claims here specify novel structural features that distinguish it.

Q4: Can competitors develop similar drugs without infringing?
Potentially, by modifying structural features outside the scope of the claims—especially the substitutions specified in dependent claims.

Q5: What markets does this patent protect?
Initially, the U.S. market; also protected in Europe, Asia, and other regions through international filings.


References

[1] U.S. Patent and Trademark Office. (2023). Patent full-text and image database. https://patft.uspto.gov
[2] WIPO. (2023). Patent scope. https://patentscope.wipo.int.
[3] European Patent Office. (2023). Espacenet. https://worldwide.espacenet.com.

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Drugs Protected by US Patent 12,409,180

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Verona Pharma OHTUVAYRE ensifentrine SUSPENSION;INHALATION 217389-001 Jun 26, 2024 RX Yes Yes ⤷  Start Trial ⤷  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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