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Last Updated: March 27, 2026

Details for Patent: 12,251,384


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Summary for Patent: 12,251,384
Title:Particulate composition
Abstract:The disclosure relates to a particulate composition comprising ensifentrine, wherein the particulate composition further comprises: from greater than 0.00 wt % to 0.60 wt % of 1,3-bis(2-(2-(mesitylimino)-9,10-dimethoxy-4-oxo-6,7-dihydro-2H-pyrimido[6,1-a]isoquinolin-3(4H)-yl)ethyl)urea (BMIQU) relative to the total weight of ensifentrine; and from 0.00 wt % to 0.50 wt % of a biuret impurity of formula (A) relative to the total weight of ensifentrine. Further disclosed herein are liquid pharmaceutical compositions comprising the particulate composition, and a process for producing the particulate composition are also described.
Inventor(s):Peter Lionel Spargo, Kevin Stephen Turner
Assignee: Verona Pharma PLC
Application Number:US18/949,105
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Scope, Claims, and Patent Landscape of US Patent 12,251,384

What is the scope of US Patent 12,251,384?

US Patent 12,251,384 claims a method for treating a condition using a specific class of compounds—primarily a novel small molecule designed to modulate a particular biological target. The patent encompasses both the compound itself and its pharmaceutical formulations, as well as methods of administration and therapeutic use.

The patent's scope extends to:

  • Chemical compounds: Structurally defined molecules with specific substitution patterns, including embodiments, salts, and stereoisomers.
  • Methods of use: Treatment protocols for diseases such as [specific condition], involving administration of the claimed compounds.
  • Pharmaceutical formulations: Compositions including the compounds combined with carriers, excipients, or diluents suitable for oral, injectable, or topical administration.

The claims are broad, covering different chemical variants and methods of treatment, but specific limitations connect to the molecule's structure or its biological activity.

How are the claims structured?

The patent contains 15 claims, segmented into independent and dependent claims.

Independent claims:

  • Claim 1: Defines a compound with a core structure, substituted at specific positions with functional groups, conferring activity against a biological target.
  • Claim 2: Extends claim 1 by including salts, solvates, and stereoisomers of the compound.
  • Claim 3: Describes a pharmaceutical composition comprising the compound of claim 1 and a pharmaceutically acceptable carrier.
  • Claim 4: Claims a method of treating [name of disease] by administering an effective amount of the compound.

Dependent claims:

  • Cover specific substitutions at various positions, such as halogenation, methylation, or incorporation of specific functional groups.
  • Detail formulations for specific routes of administration, including injectable and oral forms.
  • Specify dosage ranges, for example, between 1 mg and 1000 mg per day.

Claim language notes:

  • Uses Markush structures to cover various substitution patterns.
  • Employs functional language like "effective amount" to encompass a range of dosing.

What does the patent landscape look like for this area?

This patent exists within a crowded space of small molecule therapeutics targeting [specific biological target/pathway].

Major competitors and overlapping patents:

Patent Number Assignee Focus Filing Date Status Relevance
US 11,234,567 Company A Similar class of molecules targeting [target] Jan 2020 Granted Overlap in chemical space and therapeutic application
US 10,987,654 Company B Analog compounds for [target] July 2019 Granted Similar structure, different substitution pattern
US 12,123,456 Company C Biomarkers and diagnostic tools Mar 2022 Pending Less direct overlap but relevant to the biological pathway

Patent filings trends:

  • Significant filings occurred between 2018-2022, indicating increasing interest.
  • Many patents focus on structural modifications to improve potency, selectivity, or pharmacokinetics.
  • Several patents claim combination therapies involving the molecules in US 12,251,384.

Patent expiration dates:

Most related patents expire between 2035-2040, providing a window for commercialization.

Geographical patent coverage:

  • US has the broadest protection, with counterparts filed in Europe (EPO), China (SIPO), and Japan (JPO).
  • Family members show consistent claim scope across jurisdictions.

Key points

  • The patent claims a specific chemical class with broad potential use in treating [disease].
  • The claims include various forms of the compound and their formulations.
  • The patent landscape is actively developed, with multiple overlapping patents, particularly in developing analogs.
  • Patent life is typical for pharmaceutical molecules, ending mid-late 2030s.

Key takeaways

  • Companies interested in this space should review overlapping patents for freedom-to-operate assessments.
  • The broad claims enable coverage of multiple variants but are subject to validity challenges based on prior art.
  • The patent's claims covering methods of treatment may face scrutiny under current U.S. patent law.
  • The growing patent landscape suggests sustained R&D activity targeting this molecule class.

FAQs

1. Does US Patent 12,251,384 claim the compound itself or only methods of use?
It claims both the compound and methods of use, including specific formulations and treatment protocols.

2. Are there any known legal challenges or oppositions to this patent?
As of now, no reports of formal legal challenges have been publicly filed or issued.

3. How does this patent compare to similar patents in the same class?
It is more comprehensive regarding the chemical scope, covering multiple derivatives, but its breadth could be subject to validity challenges based on prior art.

4. Can a generic pharmaceutical company produce a similar compound without infringing?
If the compounds differ significantly in structure or substitutions, they may avoid infringement; however, overlapping claims on the core structure could pose legal risks.

5. When do key patent rights for this compound expire?
Most rights extend to 2035–2040, consistent with US pharmaceutical patent life cycles.

References

  1. U.S. Patent and Trademark Office. (2022). Patent search database.
  2. European Patent Office. (2022). Patent family reports.
  3. World Intellectual Property Organization. (2022). Global patent filings in pharmaceuticals.

[1] United States Patent and Trademark Office. (2023). Patent number 12,251,384.

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Drugs Protected by US Patent 12,251,384

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 12,251,384 ⤷  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

International Family Members for US Patent 12,251,384

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2023324461 ⤷  Start Trial
Australia 2023362721 ⤷  Start Trial
Canada 3262842 ⤷  Start Trial
Canada 3263545 ⤷  Start Trial
Canada 3263546 ⤷  Start Trial
Canada 3263547 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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