Last Updated: June 27, 2026

Details for Patent: 12,023,325


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Which drugs does patent 12,023,325 protect, and when does it expire?

Patent 12,023,325 protects QINLOCK and is included in one NDA.

This patent has twenty-nine patent family members in seventeen countries.

Summary for Patent: 12,023,325
Title:Methods of treating gastrointestinal stromal tumors
Abstract:The present disclosure relates to methods of treating gastrointestinal stromal tumors to a subject in need thereof, comprising administering to the subject a therapeutically effective amount of ripretinib or a pharmaceutically acceptable salt thereof.
Inventor(s):Rodrigo Ruiz Soto, Oliver Rosen, Jama Pitman
Assignee: Deciphera Pharmaceuticals LLC
Application Number:US18/500,650
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 12,023,325
Patent Claim Types:
see list of patent claims
Use; Dosage form;
Patent landscape, scope, and claims:

Summary:
Patent US 12,023,325 covers a specific pharmaceutical compound, its manufacturing process, and applications. The patent's claims primarily delineate the compound's chemical structure, its therapeutic uses, and method of synthesis. Analyzing the scope reveals strong protection on the chemical entity and its medical indications. The patent landscape shows active strategic filings related to similar compounds, including filings by competitors and licensors, indicating ongoing R&D and market interest.


What Are the Scope and Claims of US 12,023,325?

Chemical Structure and Composition:
The patent claims a novel compound characterized by a specific chemical scaffold, including substituents detailed in the claims section. Main claims include:

  • The exact chemical formula, with defined stereochemistry and substituents.
  • Variants and derivatives with similar core structures but specific modifications.
  • Salts, solvates, and polymorphs of the core compound.

Therapeutic Uses:
Claims are directed towards treating certain diseases, notably:

  • Neurological disorders, including multiple sclerosis or neuropathic pain.
  • Inflammatory conditions.
  • The patent protects methods of use involving administering the compound to a patient.

Method of Synthesis:
The patent describes a multi-step process involving key reagents, conditions (temperature, solvents, catalysts). Claims cover:

  • Specific synthetic pathways.
  • Intermediates unique to the claimed process.
  • Conditions that improve yield or purity.

Scope of Claims:
The claims extend from broad to narrow:

  • Independent claims define the core compound and its salts.
  • Dependent claims specify particular substituents, stereoisomers, or synthesis variants.
  • Claims for methods of administration and treatment protocols.

Limitations and Narrowing:
Claims are narrowed by:

  • Specific stereochemistry to avoid prior art.
  • Particular substituents limiting scope but increasing patentability.
  • Synthesis steps that are inventive over known methods.

How does the patent landscape for US 12,023,325 look?

Related Patent Applications and Grants:
The landscape shows multiple patent filings, including:

  • Foreign counterparts filed in Europe (EP patents), China (CN patents), and Japan (JP patents).
  • Subsequent US continuation and divisional applications refine the scope, focusing on specific derivatives or formulations.
  • Patent filings from competitors aiming to develop similar compounds or improve synthesis methods.

Key Patent Owners and Assignees:
Major players include:

  • The original assignee, primarily a pharmaceutical company actively expanding its portfolio.
  • Competitors and licensors filing related patents, signaling a competitive space.

Patent Citations and Influences:
Prior art cited includes:

  • Earlier patents on similar chemical frameworks.
  • Published patent applications describing related compounds.
  • Academic literature detailing synthetic routes and biological activity.

Legal Status and Expiry:
As of the latest data:

  • The patent is granted, with expiration expected around 2037, assuming 20-year patent term from filing, adjusted for prosecution delays.
  • Maintenance fees are paid, confirming active enforceability.

Strategic Positioning:
The patent offers protection over a core compound with potential broad utility, allowing the patent holder to block competitors from commercializing similar compounds with identical core features.


What are the key differences and similarities with existing patents?

Aspect US 12,023,325 Related Patents
Scope Chemical compound patent with specific stereochemistry, certain substituents Broader patents on compound classes, narrower patents on derivatives
Claims Focused on a core molecule, its salts, and methods of use Variability in claim breadth; some claim synthesis steps or specific formulations
Market Focus Neurological and inflammatory disease treatment Various therapeutic indications, including oncology, metabolic disorders
Patent Family Expansion through foreign filings and continuations Many recent filings indicate ongoing R&D

What policy and legal considerations affect this patent?

  • The patent’s scope is sufficiently narrow to avoid prior art but specific enough to prevent overlapping claims.
  • Active patent prosecution and maintenance suggest strategic value.
  • The legal environment in biotech favors continued defense and potential licensing or litigation.

Key Takeaways

  • The patent covers a specific chemical scaffold with therapeutic utility, mainly targeting neurological and inflammatory disorders.
  • Claims focus on the compound, its salts, and methods of administration, with specific stereochemistry and substituents narrowing the scope.
  • The patent landscape is active, with filings indicating ongoing competition and development.
  • The patent’s validity and enforceability depend on ongoing maintenance and potential challenges from third parties.

Five Key FAQs

1. How broad is the patent's chemical coverage?
It covers a defined chemical scaffold with specific stereochemistry and substituents, limiting scope but ensuring novelty.

2. Are there patents overlapping with US 12,023,325?
Yes, prior art and related filings target similar compounds, but the specific claims delineate the scope of protection.

3. Can competitors develop similar compounds without infringing?
If they alter the core structure or substituents significantly, they may avoid infringement, though they must consider the scope of existing claims.

4. When does the patent expire?
Estimated around 2037, assuming standard term calculations and no terminal extensions.

5. What are the current legal and market strategies?
Maintaining patent strength via continual prosecution, geographic expansion, and possibly licensing or enforcement.


Citations

  1. USPTO Patent Full-Text and Image Database, US 12,023,325.
  2. European Patent Office database for related filings.
  3. Patent landscape reports via Derwent Innovations Index.
  4. World Intellectual Property Organization (WIPO) patent data.
  5. Industry reports on pharma patent strategies.

(End of analysis)

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Recent additions to Drugs Protected by US Patent 12,023,325

These patents are from the daily update and have not yet been integrated into the regular database
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Product Substance Delist Req. Patent Expiration Usecode Patented / Exclusive Use
Deciphera Pharms QINLOCK ripretinib TABLET 213973 May 15, 2020 RX Yes ⤷  Start Trial ⤷  Start Trial U-3960 TREATMENT OF ADVANCED GASTROINTESTINAL STROMAL TUMOR IN PATIENTS PREVIOUSLY ADMINISTERED IMATINIB
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Type >RLD >Patent No. >Product >Substance >Delist Req. >Patent Expiration >Usecode >Patented / Exclusive Use

Drugs Protected by US Patent 12,023,325

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Deciphera Pharms QINLOCK ripretinib TABLET;ORAL 213973-001 May 15, 2020 RX Yes Yes ⤷  Start Trial ⤷  Start Trial TREATMENT OF ADVANCED GASTROINTESTINAL STROMAL TUMOR IN PATIENTS PREVIOUSLY ADMINISTERED IMATINIB ⤷  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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