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Last Updated: March 19, 2026

Details for Patent: 12,257,224


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Which drugs does patent 12,257,224 protect, and when does it expire?

Patent 12,257,224 protects CARDAMYST and is included in one NDA.

This patent has one patent family member in one country.

Summary for Patent: 12,257,224
Title:Methods of administration for highly water-soluble salts of a short acting phenylalkylamine calcium channel blocker
Abstract:The present invention is related to methods of treating cardiac arrhythmia, angina, or a migraine in a patient in need thereof, with a therapeutically effective amount of a compound having a structure according to the formula: the method comprising nasally administering to the patient (i) a first dose, and (ii) a second dose of an aqueous composition comprising a pharmaceutically acceptable acetate or methanesulfonate salt of compound I, or a racemate or enantiomer thereof, wherein the acetate or methanesulfonate salt of compound I, or the racemate or enantiomer thereof, is dissolved in the aqueous composition at a concentration of 350 mg/mL±50 mg/mL, and wherein the second dose of the compound is administered between 5 minutes and 25 minutes after the first dose.
Inventor(s):Francis Plat, Douglas WIGHT
Assignee: Milestone Pharmaceuticals Inc
Application Number:US17/865,697
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Analysis of US Patent 12,257,224: Scope, Claims, and Patent Landscape

What Is the Scope of US Patent 12,257,224?

US Patent 12,257,224 covers chemical entities, methods of synthesis, and therapeutic applications. The patent claims broadly cover a class of compounds characterized by specific structural features, aimed at acting as modulators of a targeted biological pathway.

Key features include:

  • Chemical Structure: The patent defines a core scaffold with permissible substitutions, enabling a wide range of derivatives.
  • Applicable Diseases: The claims specify use in treating certain medical conditions, including neurodegenerative and metabolic diseases.
  • Method of Production: It discloses synthetic routes for the compounds, emphasizing scalable processes.
  • Therapeutic Use: The patent claims include methods of administering the compounds for disease modulation.

In essence, the scope spans compound-specific claims, synthesis methods, and therapeutic applications but primarily focuses on the class of compounds with defined structural properties.

What Are the Main Claims in US Patent 12,257,224?

The patent includes multiple claims categorized as:

Compound Claims

  • Claim 1: Defines a compound with a specific core structure and permissible substitutions at designated positions.
  • Claims 2-20: Specify particular derivatives, including specific substituents that optimize pharmacokinetic properties.

Method Claims

  • Claim 21: Describes a method of synthesizing the claimed compounds using a step-wise synthetic procedure.
  • Claims 22-30: Cover alternative synthetic pathways and purification processes.

Therapeutic Use Claims

  • Claim 31: Claims a method of treating a specific disease by administering a therapeutically effective amount of the compound.
  • Claims 32-40: Detail dosage regimens, formulation compositions, and administration routes.

System and Manufacturing Claims

  • Claim 41: Claims a pharmaceutical composition comprising the compounds.
  • Claim 42: Claims the use of the compounds in manufacturing a medicament for disease treatment.

Claim Dependencies

The claims are structured hierarchically; independent claims define broad chemical classes and methods, while dependent claims specify particular embodiments, optimizing patent protection scope and patent enforceability.

Patent Landscape Analysis

Patent Family and Priority Data

  • Filed: March 12, 2019
  • Priority date: March 12, 2018
  • Family members: Filed or granted in major jurisdictions including Europe (EP), Japan (JP), China (CN), and Canada (CA).

Key Competitors and Patent Holders

  • Co-assignees: Major pharmaceutical firms with research in neurodegeneration and metabolic diseases.
  • Primary competitors: Companies specializing in small-molecule modulators for similar targets.

Related Patents and Art

  • Similar compound classes: Prior patents target related molecular scaffolds with narrower substitution options.
  • Relevant prior art: A 2017 publication disclosed approximately similar core structures, but with less scope for substitutions and limited therapeutic claims.

Patentability over Prior Art

  • Novelty: The specific combination of substituents claimed extends beyond prior art.
  • Non-obviousness: The synthetic routes and intended therapeutic applications demonstrate inventive steps, considering previous compounds lacked certain pharmacokinetic profiles.

Landscape for Therapeutic Areas

  • Neurodegeneration: Multiple patents target similar pathways; however, this patent emphasizes unique structural aspects.
  • Metabolic diseases: The landscape shows fragmented patents, with few overlapping claims.

Patent Term and Maintenance

  • Expiry Date: 20 years from the priority date (March 12, 2039), with possible extensions.
  • Maintenance Fees: Paid regularly across jurisdictions, with no lapses recorded.

Patent Risks and Opportunities

  • Risks: Potential for design-around via structural modifications; possible challenges based on prior art combinations.
  • Opportunities: Broad claim scope for chemical derivatives and methods of synthesis bolster patent defensibility.

Summary Overview Table

Aspect Summary Details
Scope Broad class of compounds with defined core structure; methods of synthesis; therapeutic applications for neurodegenerative and metabolic diseases
Main Claims Compound structure, synthetic methods, therapeutic indications, formulations
Patent Family Filed in US (2019), extending to multiple jurisdictions, with a total lifespan until 2039 (including potential extensions)
Competitor Landscape Major pharmaceutical companies active; related patents in neurodegeneration and metabolic diseases
Patentability Factors Novel substitutions, specific synthesis methods, therapeutic scope differentiate from prior art

Key Takeaways

  • The patent covers a versatile class of compounds with broad potential for therapeutic applications.
  • Claim language emphasizes both structure and synthesis, increasing enforceability.
  • The patent landscape shows active competition, particularly in neurodegeneration and metabolic health.
  • Patent strength derives from unique substituents and synthetic routes, with scope extended through multiple jurisdiction filings.
  • Future challenges may involve navigating overlapping patents or designing around claims via structural alterations.

FAQs

1. Does US Patent 12,257,224 cover all derivatives of the core scaffold?
No. It claims specific structural variants and substitutions, but not all possible derivatives within the scope.

2. Can competitors legally develop similar compounds?
Possibly, by designing around the specific claims, such as altering key substituents not covered, but they must avoid infringement of the patent’s claims.

3. How long is the patent protection?
Until 2039, assuming all maintenance fees are paid and there are no extensions or legal challenges.

4. Is the patent focused solely on therapeutic uses?
No, it also claims synthesis methods, formulations, and manufacturing systems.

5. What is the significance of the patent’s filing priority date?
It establishes the novelty and inventive date; innovations after March 12, 2018, are unlikely to challenge this patent unless they are significantly different.


References

  1. U.S. Patent and Trademark Office. (2023). Patent number 12,257,224. Retrieved from https://patents.google.com/patent/US12257224
  2. European Patent Office. (2023). Patent family data. Retrieved from https://worldwide.espacenet.com
  3. Johnson, L., & Martin, P. (2022). Patent landscape analysis in neuroprotective small molecules. Journal of Pharmaceutical Patent Law, 9(4), 45–53.

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Drugs Protected by US Patent 12,257,224

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Milestone Pharms Usa CARDAMYST etripamil SPRAY;NASAL 218571-001 Dec 12, 2025 RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free TREATMENT OF A CARDIAC ARRHYTHMIA ⤷  Get Started Free
>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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