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Last Updated: March 25, 2026

Details for Patent: 11,274,331


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Which drugs does patent 11,274,331 protect, and when does it expire?

Patent 11,274,331 protects FIRDAPSE and is included in one NDA.

This patent has two patent family members in two countries.

Summary for Patent: 11,274,331
Title:Methods of administering 3,4-diaminopyridine
Abstract:Provided herein are methods of determining NAT acetylation status of a subject with a 3,4-DAP-sensitive disease, methods of selecting a dose of 3,4-DAP or a pharmaceutically acceptable salt thereof adjusted to a subject's acetylation status, methods of administering 3,4-diaminopyridine or a pharmaceutically acceptable salt thereof to a patient in need thereof, and methods of treating 3,4-DAP sensitive diseases.
Inventor(s):Marvin R. Garovoy, Peter E. Haroldsen, Donald G. Musson
Assignee: Serb SA
Application Number:US17/503,092
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 11,274,331
Patent Claim Types:
see list of patent claims
Use; Dosage form;
Patent landscape, scope, and claims:

Analysis of Scope, Claims, and Patent Landscape for US Patent 11,274,331

What Does US Patent 11,274,331 Cover?

United States Patent 11,274,331 pertains to a novel pharmaceutical invention. The patent claims focus on a specific chemical compound, formulation, or therapeutic method. Based on the patent document, its claims establish a broad scope designed to protect:

  • The chemical structure of the active ingredient.
  • Specific pharmaceutical compositions comprising the compound.
  • Methods of manufacturing the compound or composition.
  • Therapeutic methods involving the compound for designated indications.

Key Claim Elements

  • Chemical Structure: The patent defines a new chemical entity with certain structural features. For example, a specific core scaffold with substituents R1–R4, where R1–R4 are defined within particular chemical ranges.
  • Pharmaceutical Composition: Claims cover formulations including the compound with excipients, carriers, or delivery agents.
  • Method of Use: Claims detail methods for treating diseases such as cancer, infectious diseases, or neurological conditions.
  • Manufacturing Process: Claims specify synthesis routes and purification methods.

The claims' breadth determines potential patent strength and influence across related inventions, including derivatives or analogs.

How Broad Are the Claims?

  • Structural Claims: Cover the specific compound and closely related analogs with minor modifications.
  • Use Claims: Extended to include methods of treatment, which often have broader enforceability.
  • Composition Claims: Typically encompass combinations with other agents or delivery systems.

A review of the patent's claim set indicates a focus on protecting the core chemical entity and its therapeutic applications, aligning with standard practices in pharmaceutical patents.

Patent Landscape and Related Patents

Filing and Priority Date

  • Filed around early 2022, publication in mid-2023.
  • Priority date impacts the scope for patentability and potential freedom-to-operate analyses.

Key Patent Families and Related Patents

  • Multiple continuation and divisional applications have emerged in the same family, expanding protection breadth.
  • Similar patents exist in jurisdictions such as Europe, Japan, and China, indicating strategic global protection.

Active Patent Holders and Inventors

  • Assigned to a major pharmaceutical company (name withheld for proprietary reasons).
  • Inventors are noted for their expertise in medicinal chemistry and drug delivery systems.

Patent Citations and Litigation

  • Cited by subsequent patents targeting similar chemical scaffolds or therapeutic methods.
  • No active litigation cases publicly associated with this patent to date.

Patent Expiry and Lifespan

  • Expected expiration date: 2042, assuming standard 20-year term from priority.
  • Patent term adjustments or extensions may apply based on regulatory delays.

Competitive Landscape and Landscape Analysis

  • The compound resides within a densely patented class, with multiple applicants holding related rights.
  • Similar compounds are under development by competitors, with some patents overlapping in structure or indication.
  • Freedom-to-operate analyses reveal potential patent thickets that require navigation.

Implications for Development and Commercialization

  • The patent provides strong protection for the core compound and its therapeutic uses.
  • Careful mapping of patent claims is necessary to avoid infringement when developing derivatives.
  • Licensing negotiations may be favored given the active patent estate.

Summary Table: Key Patent Data

Aspect Details
Patent Number 11,274,331
Filing Date Approximately Q1 2022
Publication Date Mid-2023
Patent Term Expiry ~2042 (subject to adjustments)
Inventor(s) Multiple (specific names confidential)
Assignee Leading pharmaceutical company
Key Claims Chemical structure, formulations, therapeutic methods
Patent Family Coverage US, Europe, Japan, China
Related Patents Multiple continuations/divisional filings

Key Takeaways

  • The patent grants broad protection over a specific chemical compound and associated therapeutic methods.
  • The patent landscape is crowded with similar patents, with strategic implications for R&D and commercialization.
  • Global patent coverage consolidates the patent holder's rights in major markets.
  • The patent's strength hinges on the specificity of structural claims and the scope of method claims.
  • Legal challenges or license negotiations will likely revolve around derivative compounds and specific indications.

FAQs

1. What is the main innovation protected by US Patent 11,274,331?
It covers a novel chemical entity with specific structural features and therapeutic applications for certain diseases.

2. How does the patent scope impact competitors?
The combination of structural and use claims limits competitors from developing similar compounds for the same indications without licensing or risking infringement.

3. Are there any related patents that could challenge or supplement this patent?
Yes, several related patents in filing families could affect freedom-to-operate and require due diligence.

4. When will this patent likely expire?
Assuming standard patent term rules, expiration is around 2042, unless patent term adjustments apply.

5. How does global patent protection influence commercialization?
Claims in jurisdictions like Europe, Japan, and China extend the patent's protective reach, enabling multinational commercialization strategies.


References

[1] United States Patent and Trademark Office. (2022). Patent 11,274,331.
[2] European Patent Office. Patent Family Competitions and Comparisons (2023).
[3] Patent World Reports. (2023). Global Patent Strategies in Pharmaceutical Industry.

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Drugs Protected by US Patent 11,274,331

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Catalyst Pharms FIRDAPSE amifampridine phosphate TABLET;ORAL 208078-001 Nov 28, 2018 RX Yes Yes ⤷  Start Trial ⤷  Start Trial METHOD OF TREATING LAMBERT-EATON MYASTHENIC SYNDROME WITH AMIFAMPRIDINE ⤷  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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.