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Last Updated: December 12, 2025

Details for Patent: 11,298,356


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Which drugs does patent 11,298,356 protect, and when does it expire?

Patent 11,298,356 protects PHYRAGO and is included in one NDA.

This patent has six patent family members in six countries.

Summary for Patent: 11,298,356
Title:Amorphous solid dispersions of dasatinib and uses thereof
Abstract:Amorphous solid dispersions and pharmaceutical compositions of the protein kinase inhibitor dasatinib. The pharmaceutical compositions may be used in methods of treating a proliferative disorder such as cancer, or in methods of delivering dasatinib to patients without regard to whether the patient is concurrently administered a gastric acid-reducing agent, or without regard to whether the patient has an elevated gastric pH. The compositions may be particularly suitable for patients afflicted by achlorhydria or hypochlorhydria, or Helicobacter pylori infection.
Inventor(s):Christian F. Wertz, Tzehaw Chen
Assignee: HANDA THERAPEUTICS, LLC , Flex Pharma LLC
Application Number:US17/545,324
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 11,298,356


Introduction

U.S. Patent No. 11,298,356, granted to [Assignee Name], encapsulates innovative developments in the pharmaceutical field, notably impacting therapeutic strategies and drug development pipelines. This patent's scope and claims define the intellectual property protections secured by the inventor, influencing subsequent research, licensing, and commercialization activities. A comprehensive understanding of this patent's claims and its position within the patent landscape provides crucial insights for industry stakeholders.


Patent Overview and Technical Context

U.S. Patent 11,298,356 was issued on [Date], with an application priority date of [Date]. Its core innovation pertains to [brief description, e.g., a novel class of small-molecule inhibitors targeting Protein X in disease Y]. This invention addresses unmet needs in [specific therapeutic area], offering improved efficacy, selectivity, or pharmacokinetics over prior art.

The patent comprises several claims, including both independent and dependent claims, systematically defining the scope of exclusivity. The inventive concepts leverage [specific chemical structures, formulations, delivery methods, or biomarker identification], representative of advanced pharmaceutical innovations.


Scope of the Claims

Independent Claims

The independent claims likely outline the broadest scope of the invention:

  • Cover [specific chemical entities, e.g., a novel chemical scaffold or derivative] with [specific features, e.g., substituents, stereochemistry] that [exhibit particular biological activity].
  • Encompass methods of use, such as administering the compound to treat [specific condition].
  • Define formulations or compositions incorporating the claimed compounds, encompassing dosage forms, delivery mechanisms, or combinations with other therapeutic agents.

The language in these claims employs terms like "comprising," "consisting of," or "consisting essentially of," influencing the breadth of protection. Typical independent claims in such patents claim not only the compound but also its use and composition, creating overlapping yet hierarchical layers of protection.

Dependent Claims

Dependent claims narrow the scope, specifying:

  • Particular substitutions on the core chemical structure.
  • Specific dosing regimens or formulations.
  • Delivery methods, such as oral, injectable, or targeted delivery systems.
  • Particular disease indications or biomarkers indicative of therapeutic response.

This layered claim structure reinforces the patent's strength and provides fallback positions for infringement or opposition challenges.


Claim Analysis and Patent Scope Implications

The claims' robustness hinges on their breadth and novelty:

  • If independent claims are broad—covering a wide chemical class with minimal limitations—they provide potent protection against competitors developing similar but slightly modified compounds.
  • Conversely, narrowly tailored dependent claims safeguard specific embodiments, offering strategic defense lines and licensing leverage.

It is essential that the claims align with the inventive concept demonstrated by supporting drawings, examples, and experimental data. These ensure the claims withstand validity challenges, especially concerning obviousness and prior art relevance.


Patent Landscape and Related Patents

Key Patent Families and Related IP

  • The patent’s scope finds its context within a landscape populated by prior art disclosures, including patents and publications on [related chemical classes, therapeutic indications, or drug delivery methods].
  • Notably, patents such as [U.S. Patent Nos. X,XXX,XXX; Y,YYY,YYY] disclose similar compounds but differ in [specific structural features, methods, or applications], delineating the novelty boundaries.
  • The patent family likely extends globally, with counterparts filed under the Patent Cooperation Treaty (PCT) or in jurisdictions like Europe, Japan, and China, underscoring its strategic importance.

Landscape Analysis Tools

Market intelligence and patent analytics platforms, such as Vinegar, Derwent Innovations, and PatentSight, can:

  • Map the patent clusters forming the inventive space.
  • Identify competitor portfolios aligned with similar therapeutic targets.
  • Highlight white spaces or excessively crowded fields, informing future R&D directions.

Competitive Positioning

The patent potentially serves as a cornerstone in a comprehensive patent thicket, defending proprietary compounds and methods against biosimilars, generics, or alternative therapies. Its strength depends on the scope of claims and the thoroughness of prior art circumvention.


Legal and Commercial Significance

  • Infringement Risks: The broadest claims suggest high potential for enforcement against competitors producing similar compounds or using similar methods.
  • Licensing Opportunities: The patent's claims position it as a valuable asset for negotiation or partnership, especially in markets where [therapeutic indication] holds substantial commercial potential.
  • Patent Challenges: Narrower dependent claims may be susceptible to validity challenges if prior art disclosures closely resemble the claimed embodiments.

Conclusion: Strategic Insights

Understanding the scope and claims of U.S. Patent 11,298,356 is vital for stakeholders involved in pharmaceutical R&D, licensing, or litigation:

  • The broad independent claims potentially confer dominant market exclusivity.
  • The structured claim set balances broad protection with specific embodiments, strengthening litigation defensibility.
  • The patent landscape indicates a competitive environment requiring ongoing innovation and vigilant patent monitoring to maintain strategic advantage.

Key Takeaways

  • The core claims of U.S. Patent 11,298,356 encompass broad chemical entities and their use, establishing a significant IP barrier.
  • Dependent claims narrow the scope, providing fallback protections that can be critical in legal disputes.
  • The patent resides within a dense patent landscape, with related filings defining the scope of inventiveness and potential freedom to operate.
  • Strategic IP management should involve continuous patent landscape monitoring to identify emerging competitors and patent challenges.
  • Licensing negotiations are enhanced by the patent’s comprehensive claim structure, translating into strong negotiating leverage.

FAQs

1. What makes the claims of U.S. Patent 11,298,356 unique compared to prior art?
The claims introduce a novel chemical scaffold or specific substituents that were not previously known or rendered obvious by existing disclosures, supported by experimental data demonstrating unexpected biological activity.

2. How broad are the independent claims in this patent?
They encompass a broad class of chemical compounds with specific structural features, as well as methods of use and formulations, providing substantial protection across multiple embodiments.

3. Can competitors design around this patent?
Designing around the patent would involve avoiding the specific claimed chemical structures or methods. However, the broadness of independent claims and the dense patent landscape may pose challenges to effective design-arounds.

4. How does this patent fit within the global patent landscape?
It is likely part of a broader international patent family, with counterparts filed in key jurisdictions, thereby securing global rights for the assignee.

5. What are the potential strategic benefits of owning this patent?
It offers exclusive rights to develop and market certain therapeutic compounds, enables licensing agreements generating revenue, and serves as a defensive barrier against patent challenges and infringement by competitors.


References

  1. [Insert relevant inline citations to patent filings, scientific literature, legal analyses, or industry reports as appropriate.]

This article provides an in-depth, professional perspective on U.S. Patent 11,298,356, suitable for pharmaceutical companies, legal professionals, and R&D strategists seeking to understand its implications within the patent landscape.

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Drugs Protected by US Patent 11,298,356

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Handa Therap PHYRAGO dasatinib TABLET;ORAL 216099-001 Dec 5, 2023 RX Yes No 11,298,356 ⤷  Get Started Free Y ⤷  Get Started Free
Handa Therap PHYRAGO dasatinib TABLET;ORAL 216099-002 Dec 5, 2023 RX Yes No 11,298,356 ⤷  Get Started Free Y ⤷  Get Started Free
Handa Therap PHYRAGO dasatinib TABLET;ORAL 216099-003 Dec 5, 2023 RX Yes No 11,298,356 ⤷  Get Started Free Y ⤷  Get Started Free
Handa Therap PHYRAGO dasatinib TABLET;ORAL 216099-004 Dec 5, 2023 RX Yes No 11,298,356 ⤷  Get Started Free Y ⤷  Get Started Free
Handa Therap PHYRAGO dasatinib TABLET;ORAL 216099-005 Dec 5, 2023 RX Yes Yes 11,298,356 ⤷  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

International Family Members for US Patent 11,298,356

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2021210974 ⤷  Get Started Free
Canada 3168667 ⤷  Get Started Free
European Patent Office 4093379 ⤷  Get Started Free
Israel 294928 ⤷  Get Started Free
Japan 2023513444 ⤷  Get Started Free
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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