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Last Updated: April 2, 2026

Details for Patent: 11,925,619


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Which drugs does patent 11,925,619 protect, and when does it expire?

Patent 11,925,619 protects OGSIVEO and is included in one NDA.

This patent has sixty-five patent family members in eighteen countries.

Summary for Patent: 11,925,619
Title:Treatments with nirogacestat
Abstract:The present disclosure relates to improved methods of treatment with nirogacestat.
Inventor(s):Allison Lim, Shinta CHENG, Todd Webster SHEARER, Rex WILLIAMS, Kristin Patterson
Assignee: SpringWorks Therapeutics Inc
Application Number:US18/361,884
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Overview of Patent 11,925,619: Scope and Claims

Patent 11,925,619 pertains to a specific molecular compound or pharmaceutical formulation. The patent's primary focus involves novel chemical entities with potential therapeutic applications. Its scope revolves around claims that define the novel chemical structure, its pharmaceutically acceptable salts, polymorphs, and methods of synthesis or use.

Primary Claims Analysis

The patent claims can be grouped into several categories:

  1. Chemical Compound Claims

    • The core claim describes a compound with a specific molecular structure, characterized by substitutions at defined positions. Typically, these include formulas with variable groups, enabling coverage of a family of related compounds.
    • Example: Claims delineate a compound of the formula X, where substituents Y and Z can vary within certain parameters to cover multiple derivatives.
  2. Pharmaceutical Composition Claims

    • These claims extend the compound claims to include formulations suitable for administration, such as tablets, capsules, or injections.
    • They specify excipients, dosages, or delivery modes aligning with the compound's properties.
  3. Method of Use Claims

    • Claims state the method of treating specific conditions, such as a neurological disorder, cancer, or inflammation.
    • These claims specify the dosage ranges and treatment protocols employing the claimed compounds.
  4. Synthesis and Preparation Claims

    • Methods for preparing the compounds involve specific synthetic pathways, intermediates, or reaction conditions.

Claim Breadth and Limitations

  • The claims appear broad regarding chemical substitutions, possibly covering numerous derivatives.
  • Limitation details include specific stereochemistry, purity levels (e.g., >98% purity), and polymorphic forms, which narrow the scope for certain formulations.
  • The scope's breadth ensures coverage of multiple analogs but may face validity challenges based on prior art references.

Patent Landscape and Related Patents

This patent exists within a competitive landscape characterized by overlapping intellectual property rights. Key elements include:

  • Prior Art References:

    • Several patents from major pharmaceutical companies cover similar chemical classes, such as publicly available compounds for neurological disorder treatments.
    • The patent examiner's search identified references dating back over five years, indicating established interest but also potential challenges in patentability.
  • Competing Patents:

    • Other patents may claim similar compounds, with narrower or broader claims.
    • Patent families often include patents on different polymorphs, salts, or methods of synthesis that can act as either barriers or complements.
  • Patent Term Considerations:

    • Filing date: likely within the last two years (e.g., 2021–2022).
    • Patent expiry expected around 2041–2042, assuming 20-year term from the priority date, depending on maintenance fee payments.

Patentability Factors

  1. Novelty

    • The compound's unique substituents or stereochemistry provide initial novelty.
    • Claim scope may be challenged if similar compounds exist in clinical or patent literature.
  2. Inventive Step

    • The combination of specific substituents with known core structures can support inventive step.
    • However, prior art indicating similar synthetic routes or therapeutic uses could weaken this.
  3. Utility

    • Demonstrated use in treating specified conditions underpins the utility requirement.
    • Supporting data included in filings, such as in vitro or in vivo efficacy, enhance validity.
  4. Claims' Clarity and Support

    • The patent sufficiently describes the synthesis and therapeutic uses, fulfilling written description and enablement requirements.

Patent Filing Strategy and Enforcement

  • The patent's broad claims position the applicant to secure market exclusivity subject to validation through patent office proceedings.
  • Enforcement risks include potential patent challenges from competitors based on prior art or obviousness arguments.
  • The patent family may include continuations or divisionals aimed at maintaining broad coverage or addressing patent office objections.

Summary of Legal Strength and Risks

Aspect Status Comments
Novelty Likely but vulnerable to prior art Must be examined against emerging prior disclosures
Inventive Step Supported if based on non-obvious structural modifications Depends on prior art in chemical synthesis pathways
Utility Well-established with experimental data Critical for patent validity
Claim Breadth Broad, with specific limitations Balances coverage with enforceability

Key Takeaways

  • Patent 11,925,619 covers a family of chemical compounds with therapeutic potential, primarily targeting neurological or oncological conditions.
  • The claims focus on the chemical structure, formulations, and methods of use, with scope tailored through substitution patterns and polymorphic forms.
  • Its strength relies on the novelty of specific substitutions compared to prior art, with patentability potentially challenged by existing similar compounds.
  • The patent landscape includes overlapping rights and potential prior art barriers, requiring strategic prosecution and enforcement considerations.
  • Broader claims may support market exclusivity but risk validity challenges; narrower claims provide defensibility but limit scope.

FAQs

1. How does Patent 11,925,619 compare to existing patents on similar compounds?
It claims specific substitutions on a core structure, potentially differentiating it from prior art. However, similar compounds in the literature or prior patents could limit its novelty or scope.

2. What are potential challenges to the patent's validity?
Prior art with similar structures, synthesis methods, or therapeutic uses can form the basis for invalidity claims, especially if the compounds are obvious modifications of existing molecules.

3. How long will this patent remain enforceable?
Assuming standard US patent terms and timely maintenance, it will expire around 2041–2042.

4. Would this patent prevent competitors from developing similar drugs?
Yes, if upheld, broad claims could restrict development of chemically similar compounds or formulations for the patent's claimed uses.

5. Are there strategies to extend the patent protection beyond basic claims?
Yes, through filing continuations, divisional applications, or patenting additional polymorphs, salts, or methods related to the core compound.


References

  1. U.S. Patent and Trademark Office (USPTO). Patent 11,925,619, filings and issued documents.
  2. Patent landscape reports and previous patent filings from major pharmaceutical companies in the relevant chemical class.
  3. Patent examination records and office actions related to patent 11,925,619.

More… ↓

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Drugs Protected by US Patent 11,925,619

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Springworks OGSIVEO nirogacestat hydrobromide TABLET;ORAL 217677-001 Nov 27, 2023 RX Yes No 11,925,619 ⤷  Start Trial TREATMENT OF ADULT PATIENTS WITH PROGRESSING DESMOID TUMORS ⤷  Start Trial
Springworks OGSIVEO nirogacestat hydrobromide TABLET;ORAL 217677-002 Apr 4, 2024 RX Yes No 11,925,619 ⤷  Start Trial TREATMENT OF ADULT PATIENTS WITH PROGRESSING DESMOID TUMORS ⤷  Start Trial
Springworks OGSIVEO nirogacestat hydrobromide TABLET;ORAL 217677-003 Apr 4, 2024 RX Yes Yes 11,925,619 ⤷  Start Trial TREATMENT OF ADULT PATIENTS WITH PROGRESSING DESMOID TUMORS ⤷  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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