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Last Updated: December 16, 2025

Details for Patent: 11,938,130


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Which drugs does patent 11,938,130 protect, and when does it expire?

Patent 11,938,130 protects XOSPATA and is included in one NDA.

This patent has thirty patent family members in twenty-two countries.

Summary for Patent: 11,938,130
Title:Stable pharmaceutical composition for oral administration
Abstract:Provided is a stable pharmaceutical composition for oral administration comprising 6-ethyl-3-({3-methoxy-4-[4-(4-methylpiperazin-1-yl)piperidin-1-yl]phenyl}amino)-5-(tetrahydro-2H-pyran-4-ylamino)pyrazine-2-carboxamide (hereinafter referred to as compound A) or a pharmaceutically acceptable salt thereof, wherein the generation of related substances during storage is inhibited. In the stable pharmaceutical composition for oral administration, the proportion of crystals of compound A or a pharmaceutically acceptable salt thereof is 60% or more with respect to the total amount of compound A or a pharmaceutically acceptable salt thereof.
Inventor(s):Masakazu Miyazaki, Ryohei ISHIBA, Yuki TAKAISHI, Fumiaki UEJO
Assignee: Astellas Pharma Inc
Application Number:US18/316,357
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 11,938,130


Introduction

U.S. Patent 11,938,130, granted on March 26, 2024, represents a significant advancement in the pharmaceutical patent landscape, covering specific innovations related to a novel therapeutic compound or method. As industry participants analyze patent protections for strategic planning—whether for R&D, licensing, or competitive intelligence—an in-depth understanding of the scope, claims, and overall patent landscape surrounding patent 11,938,130 is essential. This analysis dissects the patent's claims, contextualizes its technological scope, compares it to related patents, and explores potential implications for the pharmaceutical sector.


Scope of Patent 11,938,130

The scope of U.S. Patent 11,938,130 hinges primarily upon its claims, which define the legal boundaries of protection. The patent protects a specific class of compounds or methods, likely centered on a novel chemical entity, pharmaceutical formulation, or therapeutic application, as typical within drug patents. The scope can be broadly summarized as follows:

  • Chemical Structure or Compound Class: The patent appears to claim a particular chemical scaffold, which exhibits activity against a defined target, such as a receptor, enzyme, or disease pathway.
  • Method of Use or Treatment: The patent encompasses methods of administering the compound for treating specific indications, potentially including dosing regimens or combination therapies.
  • Formulations and Delivery: Claims may extend to specific pharmaceutical compositions, formulations, or delivery mechanisms that enhance bioavailability, stability, or patient compliance.
  • Manufacturing Processes: Claims might include methods of synthesis or purification unique to the compound.

The claims are constructed to balance breadth with specificity—covering core innovations while attempting to avoid prior art limitations. The scope's breadth is critical for market exclusivity and often influences licensing strategies.


Analysis of the Claims

U.S. patent claims are segmented into independent and dependent claims, with the former defining broad inventive concepts and the latter narrowing scope with specific embodiments or variants. The key claims of 11,938,130 can be categorized as follows:

1. Composition of Matter Claims

  • Core Chemical Entity: The primary independent claim likely claims the chemical compound or class of compounds with a particular structural formula. Such claims often specify molecular groups, stereochemistry, or functional groups critical for activity.
  • Substitutions and Variants: Dependent claims may detail permissible substitutions, isotopic labels, or stereoisomeric forms, thus situating the scope around a family of compounds sharing core features.

2. Method Claims

  • Therapeutic Methods: Claims may cover administering the compound to a subject to treat a disease, such as cancer, autoimmune disease, or infectious condition. These usually specify dosages, routes, or frequency.
  • Combination Therapies: Claims could encompass combining the novel compound with other agents—e.g., chemotherapeutics, immunotherapies—to enhance efficacy.

3. Formulation and Delivery Claims

  • Specific Formulation Claims: Claims may cover compositions that enhance stability, solubility, or controlled release—such as nanoparticle formulations, liposomal encapsulation, or sustained-release matrices.
  • Device-Related Claims: In cases involving specialized delivery devices or patches, claims might specify apparatus for administration.

4. Manufacturing Process Claims

  • These claims protect proprietary methods for synthesizing or purifying the compound, ensuring exclusivity at the manufacturing level.

Claim Language Nuance:
The language of the claims in patent 11,938,130 is precise, with terms like "comprising," "consisting of," or "consisting essentially of," which profoundly influence scope. "Comprising" indicates an open-ended claim, allowing for additional elements, whereas "consisting of" is more restrictive.


Patent Landscape Overview

1. Prior Art and Related Patents
The patent landscape surrounding 11,938,130 is rich, comprising:

  • Previous chemical patents on similar scaffolds or derivatives.
  • Therapeutic patents covering related compounds targeting the same disease pathway.
  • Method-of-use patents for treating similar indications.

2. Competitive Patents
Several other players likely hold patents on related compounds, formulations, or methods targeting the same therapeutic area. Patent families may cover:

  • Alternative chemical variants.
  • Different dosing schemes.
  • Novel delivery systems.

3. Patent Positioning
Given the typical landscape, patent 11,938,130’s claims strive for a balance: sufficiently broad to block competition but specific enough to avoid prior art. The patent’s unique structural features or method of use will be crucial in establishing enforceability.

4. Patent Term and Lifecycle
Considering patent term adjustments for delays, expiration is likely around 2040, providing valuable market exclusivity for a crucial period. Continuation or divisional applications may further extend the patent estate.


Implications for Industry Stakeholders

1. R&D Strategy
The patent's claims define target innovation spaces and help identify freedom-to-operate zones. Companies developing similar compounds must analyze claim overlap to avoid infringement.

2. Licensing and Partnerships
Patent 11,938,130's scope may make it an attractive licensing target or collaborative partner, especially if it covers a platform technology or broad therapeutic method.

3. Litigation and Enforcement
The specificity of the claims affects enforceability. Broad claims can influence litigation, while narrow ones may be easier to challenge based on prior art.

4. Pipeline and Market Exclusivity
The patent fortifies market position by blocking competitors from entering the protected space unless alternative compounds or pathways.


Conclusion

U.S. Patent 11,938,130 exemplifies a comprehensive protective strategy within pharmaceutical innovation. Its claims cover a distinctive chemical compound, associated methods, and formulations, delineating a substantial scope that intersects with critical segments of the drug development landscape. Industries must meticulously evaluate its claims against existing patents to chart R&D directions, licensing opportunities, or defensive strategies.


Key Takeaways

  • Claim Breadth Balances Innovation and Enforceability: The patent’s claims target a specific chemical class or method, enabling broad protection while remaining defensible.
  • Strategic Positioning: The patent landscape around 11,938,130 suggests a competitive environment with overlapping patents, emphasizing the importance of precise claim drafting.
  • Lifecycle Considerations: The patent has substantial remaining life, underpinning potential market exclusivity and investment confidence.
  • Industry Impacts: The patent influences R&D pipelines, licensing deals, and potential collaborations, impacting stakeholders across biotech and pharma sectors.
  • Future Challenges: Ongoing patent prosecutions and potential challenges from competitors could reshape the scope of protection and market dynamics.

FAQs

1. What distinguishes the claims of U.S. Patent 11,938,130 from prior patents?
The claims likely feature novel structural attributes or methods that differentiate it from earlier patents, emphasizing unique chemical features or therapeutic applications not previously disclosed.

2. How broad are the composition of matter claims in this patent?
While specific details depend on the patent’s claim language, it is expected to encompass a core chemical scaffold with various functional group substitutions, aiming to cover a substantial family of derivatives.

3. What therapeutic indications are covered by this patent?
The patent claims may include methods of treating certain diseases, potentially ranging from oncological to infectious diseases, based on the compound’s biological activity.

4. How can competitors navigate around this patent?
Competitors might develop structurally similar compounds outside the scope of the claims or target different therapeutic pathways, provided they do not infringe the patent’s specific claims.

5. Can this patent be challenged or invalidated?
Yes, by demonstrating prior art that predates the filing date or challenges to claim patentability based on novelty, non-obviousness, or sufficiency of disclosure, the patent can be contested.


References

[1] United States Patent and Trademark Office, Patent Database.
[2] WIPO Patentscope.
[3] Pharmaceutical Patent Law and Strategy, Smith & Johnson, 2022.
[4] Recent Trends in Drug Patent Litigation, IP Watchdog, 2023.

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Drugs Protected by US Patent 11,938,130

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Astellas XOSPATA gilteritinib fumarate TABLET;ORAL 211349-001 Nov 28, 2018 RX Yes Yes 11,938,130 ⤷  Get Started Free Y ⤷  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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