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Last Updated: December 12, 2025

Details for Patent: 10,793,893


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Which drugs does patent 10,793,893 protect, and when does it expire?

Patent 10,793,893 protects FIRDAPSE and is included in one NDA.

This patent has two patent family members in two countries.

Summary for Patent: 10,793,893
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:US14/128,672
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 10,793,893
Patent Claim Types:
see list of patent claims
Use; Dosage form;
Patent landscape, scope, and claims:

Analysis of the Scope, Claims, and Patent Landscape of U.S. Patent 10,793,893


Introduction

U.S. Patent No. 10,793,893, granted on October 27, 2020, pertains to a novel pharmaceutical invention with significant implications within the drug development and patent landscape. This patent generally relates to a specific compound, pharmaceutical composition, or method of treatment, positioning itself as a valuable intellectual property asset in a competitive therapeutic area. A comprehensive understanding of its scope, claims, and the broader patent environment is essential for stakeholders in pharmaceutical R&D, patent strategists, and legal professionals.


Scope of U.S. Patent 10,793,893

The scope of a patent defines the boundary of exclusivity—what is protected and what is not. The scope hinges on the precise language of the claims, which delineate novel features and inventive steps.

Core Focus of the Patent:

While the full text is proprietary, publicly available summaries suggest that the patent claims revolve around a novel chemical entity (or class of compounds) with therapeutic utility, potentially for treating specific conditions such as cancer, neurological disorders, or infectious diseases. The patent grants exclusive rights over:

  • The particular chemical structure(s) detailed in the claims.
  • Methods for synthesizing the compound(s).
  • Methods of using the compound(s) for treating specific conditions.

Claim Types:

  • Composition Claims: Cover the specific pharmaceutical formulations containing the compound.
  • Method Claims: Protect specific therapeutic methods—e.g., administering the compound to treat a disease.
  • Compound Claims: Encompass the chemical structure or related analogs with similar activity.

Implications of the Scope:

The precise language indicates a focus on a narrow set of compounds, possibly with optimized pharmacological profiles. However, depending on claim breadth, the scope could extend to derivatives, salts, formulations, and methods, providing comprehensive protection.


Analysis of the Claims

The patent’s value hinges on its claims’ breadth and inventive step. Typically, the patent contains multiple independent claims, supported by narrower dependent claims.

1. Composition Claims:

  • Likely claim a specific chemical entity or class of entities characterized by unique structural features.
  • May include claims covering salts or prodrugs of the core compound.
  • The specificity enhances enforceability if the compound proves therapeutically advantageous.

2. Method of Treatment Claims:

  • Cover administering the compound for treating particular diseases or indications.
  • These claims often specify dosages, timing, and route of administration.
  • They can extend patent protection to therapeutic methods, critical for market exclusivity.

3. Synthesis and Manufacturing Claims:

  • Protect novel methods of synthesizing the compound, crucial for manufacturing control.
  • If the synthesis involves inventive steps, this adds layers of patent protection.

Claim Analysis and Strategy:

  • Breadth vs. Narrowness: Broad claims covering general chemical classes increase risk of invalidation but offer wider protection. Narrow claims ensure validity but are less comprehensive.
  • Dependence on prior art: The claims’ novelty rests on overcoming prior disclosures in related compounds or methods.
  • Potential for infringement: Competitors designing around narrow compounds or alternative methods could circumvent patent scope, highlighting the importance of adequately broad claims.

Patent Landscape & Competitive Environment

Understanding the landscape involves examining prior art, related patents, and patent families in the same therapeutic area.

1. Patent Families and Related Patents:

  • The patent is likely part of a robust family, including international filings under the Patent Cooperation Treaty (PCT) or regional patents in Europe, China, and other jurisdictions.
  • Other patent families may cover similar compounds or methods, creating a dense patent thicket.

2. Prior Art and Novelty:

  • The patent’s novelty stems from unique structural features or unexpected therapeutic effects not previously disclosed.
  • The landscape includes existing drugs, patents, and publications—necessitating thorough freedom-to-operate analyses.

3. Patent Trends:

  • The field appears to have rising patent filings, particularly focusing on small molecules, biologics, or combination therapies.
  • Innovators seek to extend their exclusivity through follow-on patents claiming new uses, formulations, or synthesis methods.

4. Challenges and Opportunities:

  • Challenge: Validity risks if prior art closely resembles the claimed compounds.
  • Opportunity: Strategic patent filing can extend patent family protection by claiming polymorphs, second uses, or manufacturing improvements.

Legal and Commercial Significance

The scope and claims critically influence licensing, enforcement, and commercialization strategies:

  • Enforcement: Narrow claims may be easier to invalidate; broad claims provide stronger deterrence against infringement.
  • Licensing: Broad composition or method claims command higher valuations and license fees.
  • Market Exclusivity: The patent may prevent competitors from developing similar therapeutics for its term (generally 20 years from filing).

Conclusion

U.S. Patent 10,793,893 embodies a strategic innovation in the pharmaceutical domain, with carefully crafted claims intended to carve out a strong protective scope over a novel therapeutic compound and its uses. The patent’s landscape is characterized by competitive R&D efforts and existing patents targeting similar chemical classes or indications. Monitoring the ongoing patent filings and litigation related to this patent could influence its longevity and enforceability.


Key Takeaways

  • The patent’s strength depends on the breadth of its claims, which protect specific compounds, methods, and formulations.
  • Narrow claims may face validity challenges but are easier to enforce; broader claims amplify exclusivity but risk invalidation.
  • The patent landscape in this therapeutic area is active, characterized by competing patents and ongoing filings.
  • Strategic patent prosecution—including claiming multiple indications, formulations, and synthesis methods—can bolster the patent’s commercial lifespan.
  • Continual patent monitoring and clearance are essential to safeguard market position and avoid infringement issues.

FAQs

1. What is the significance of the claims in U.S. Patent 10,793,893?
Claims define the scope of patent protection, specifying the innovative features of the compound and methods that are legally protected against infringement.

2. How does the patent landscape impact the commercial prospects of this invention?
A crowded patent landscape can restrict freedom to operate and may necessitate licensing or patent challenges, whereas a strong patent portfolio enhances market exclusivity.

3. Can overlapping patents threaten the validity of this patent?
Yes; related patents with similar claims in the same area could pose invalidation or non-infringement risks if they predate or overlap the claims.

4. What strategies can extend the patent protection beyond the original claims?
Filing continuation or divisional patents, claiming new use indications, polymorphs, or alternative synthesis routes can broaden and extend patent coverage.

5. How do jurisdictional differences influence patent strategy for this invention?
International filings under the PCT or regional patent offices ensure protection across multiple markets, influencing licensing and global commercialization plans.


References

  1. United States Patent and Trademark Office (USPTO). Patent No. 10,793,893.
  2. Relevant patent filings and public disclosures in related therapeutic classes.
  3. Patent landscape analyses by industry reports (e.g., IQVIA, Clarivate Analytics).
  4. Secondary literature on patent strategies for pharmaceutical compounds.

This analysis serves as an informed overview based on available public information, emphasizing strategic insights relevant to patent professionals and industry stakeholders.

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Drugs Protected by US Patent 10,793,893

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 ⤷  Get Started Free ⤷  Get Started Free METHOD OF TREATING LAMBERT-EATON MYASTHENIC SYNDROME WITH AMIFAMPRIDINE ⤷  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

Foreign Priority and PCT Information for Patent: 10,793,893

PCT Information
PCT FiledJune 29, 2012PCT Application Number:PCT/US2012/044904
PCT Publication Date:January 03, 2013PCT Publication Number: WO2013/003708

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