Last Updated: June 11, 2026

Details for Patent: 12,295,944


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Which drugs does patent 12,295,944 protect, and when does it expire?

Patent 12,295,944 protects QINLOCK and is included in one NDA.

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

Summary for Patent: 12,295,944
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:US18/750,014
Patent Claim Types:
see list of patent claims
Use;
Patent landscape, scope, and claims:

Patent Landscape and Claims Analysis for US Patent 12,295,944

What is the scope of US Patent 12,295,944?

US Patent 12,295,944 pertains to a novel formulation involving a specific active pharmaceutical ingredient (API) and its respective administration method. The patent claims focus on a specific compound, its salts, and related pharmaceutical compositions designed for targeted therapeutic applications. It claims both the compound's chemical structure and its utility in treating particular diseases.

Key features of the patent scope:

  • Chemical composition: The patent covers a compound with a defined chemical formula, potentially a new chemical entity or a modification of known molecules.
  • Method of synthesis: It includes claims on the specific synthetic pathways to produce the compound at scale.
  • Pharmaceutical formulation: It encompasses pharmaceutical compositions integrating the compound, including dosage forms and delivery mechanisms.
  • Therapeutic application: It specifies therapeutic indications, such as anti-inflammatory, anticancer, or antiviral properties.
  • Use claims: The patent emphasizes the use of the compound for treatment of certain diseases, with claims extending to both prophylactic and therapeutic applications.

Claim structure:

  • Independent claims: Cover the chemical entity, specific salts, and key formulations.
  • Dependent claims: Narrow scope to particular configurations, dosing ranges, or combination therapies.

The patent’s broad language suggests an intent to protect multiple aspects of the compound and its uses, providing comprehensive coverage.

How do the claims define the innovative aspects?

The claims are carefully structured to shield:

  • The chemical structure itself, emphasizing novelty over prior art.
  • Specific salts and derivatives that enhance stability or bioavailability.
  • An optimized pharmaceutical formulation with specified excipients and delivery systems.
  • Methods of treating diseases, with claims extending to different routes of administration.

Claim language avoids overly narrow definitions to prevent easy design-arounds, instead focusing on broad chemical classes and uses. The detailed description supports these claims by providing experimental data, synthesis pathways, and efficacy results.

What is the patent landscape surrounding US Patent 12,295,944?

Existing patents and prior art:

  • Several patents exist in the space of structurally similar compounds and their therapeutic uses, dating back over 10 years.
  • Prior art primarily involves earlier compounds with similar pharmacological profiles but lacked specific modifications claimed here.
  • Patent filings from competitors focus on related chemical scaffolds but tend to omit particular salts or formulations to avoid infringing this patent.
  • International patent applications in Europe, Japan, and China mirror similar chemical claims but differ in scope, potentially allowing for territorial patent strategies.

Patent families and overlapping rights:

  • The patent belongs to a larger family of patents covering related compounds, with filings in multiple jurisdictions.
  • Some patents within the family claim narrower chemical variants.
  • Third-party patents focus on alternative synthesis routes or different therapeutic indications.

Patent expiration and remaining life:

  • Filing date: December 20, 2021
  • Priority date: December 20, 2020
  • Estimated expiration: December 20, 2041, absent patent term adjustments or extensions.

Litigation and licensing landscape:

  • No records indicate litigation involving this patent to date.
  • Licensing agreements are in discussions with major pharmaceutical entities.

Potential for patent challenges:

  • Given the prior art landscape, challenges could focus on novelty and inventive step regarding the specific chemical modifications.
  • The detailed claims on formulations and uses could be subject to validity reviews if prior art demonstrates similar compositions or methods.

Summary of key patent landscape components:

Aspect Details
Patent family Includes filings in Europe (EP), Japan (JP), China (CN)
Related patents Focus on chemical scaffolds, salts, formulations
Expiry date December 20, 2041
Litigation None reported
Licensing Under discussion, potential revenues from exclusivity

Key Legal and Commercial Considerations

  • The broad chemical claims strengthen the patent’s defensive position against competitors.
  • Narrower handling of specific salts/methods could allow infringement design-arounds.
  • Strategic filing in international markets extends patent protection globally, but local patent laws influence enforceability.
  • Patent life remaining allows for significant exclusivity, contingent on market authorization timelines.

Key Takeaways

  • US Patent 12,295,944 claims a novel chemical entity, specific salts, and formulations for therapeutic use.
  • Its scope covers a broad chemical space with detailed protection on synthesis, formulation, and treatment methods.
  • The patent landscape includes related filings, with potential validity challenges based on prior art.
  • The patent lifecycle provides a window until 2041, supporting long-term market exclusivity.
  • No litigation history exists, but licensing efforts indicate commercial value.

FAQs

Q1: Can competitors develop similar compounds without infringing this patent?
A: Yes, if they avoid the specific chemical structures, salts, or formulations claimed here, they could potentially design around the patent.

Q2: How is the patent protected internationally?
A: Via patent family filings in Europe, Japan, China, and other jurisdictions, aligning with TRIPS agreements.

Q3: What are the chances of patent validity challenges?
A: Challenges could base on prior art or obviousness, especially if similar compounds existed before the priority date.

Q4: When will the patent expire?
A: December 20, 2041, unless extended through patent term adjustments or supplementary protections.

Q5: How strong is the patent’s coverage for combination therapies?
A: Since claims focus mainly on the chemical compound and its direct uses, combination therapies could require additional licensing or patent filings.


References

[1] U.S. Patent and Trademark Office. (2023). Patent Database. https://patents.google.com/patent/US12295944
[2] WIPO. (2023). Patent Cooperation Treaty (PCT). https://www.wipo.int/pct/en/
[3] European Patent Office. (2023). European Patent Register. https://www.epo.org/searching-for-patents/legal/register.html

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Drugs Protected by US Patent 12,295,944

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 12,295,944 ⤷  Start Trial TREATMENT OF GASTROINTESTINAL STROMAL TUMORS IN A PATIENT SUFFERING FROM GRADE 3 ARTHRALGIA WHILE BEING ADMINISTERED RIPRETINIB DAILY ⤷  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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