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Last Updated: April 2, 2026

Details for Patent: 11,452,725


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Which drugs does patent 11,452,725 protect, and when does it expire?

Patent 11,452,725 protects AUGTYRO and is included in one NDA.

This patent has thirty-four patent family members in twenty-five countries.

Summary for Patent: 11,452,725
Title:Chiral diaryl macrocycles and uses thereof
Abstract:This disclosure relates to the use of certain diaryl macrocycle compounds, specifically (7S13R)-11-fluoro-7,13-di-methyl-6,7,13,14-tetrahydro-1,15-ethenopyrazolo[4,3-f][1,4,8,10]benzoxatriazacyclotridecin-4(5H)-one in the treatment of disease in mammals. This disclosure also relates to compositions including such compounds, and to methods of using such compositions in the treatment of diseases in mammals, especially in humans.
Inventor(s):Jingrong J. CUI, Yishan LI, Evan W. ROGERS, Dayong Zhai, Wei Deng, Zhongdong HUANG
Assignee: Turning Point Therapeutics Inc
Application Number:US16/998,763
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Analysis of U.S. Patent 11,452,725: Scope, Claims, and Patent Landscape

What is the scope of U.S. Patent 11,452,725?

U.S. Patent 11,452,725, issued on September 20, 2022, pertains to a novel method or composition involving a specific pharmaceutical agent, likely targeting a therapeutic indication, dosage form, or delivery mechanism. The patent's overall scope includes:

  • Inventive subject matter: Covers a specific API (Active Pharmaceutical Ingredient), its formulation, or a method of use.
  • Claims: Define the boundaries of patent protection, focusing on the compound, its synthesis, or its therapeutic application.
  • Protection breadth: Likely includes claims broad enough to cover related analogs, derivatives, or methods of administration, while remaining specific enough to distinguish from prior art.

The patent appears to encompass claims that cover:

  • Particular chemical structures or classes.
  • Methods of manufacturing or synthesizing the compound.
  • Treatment methods involving the compound for a designated medical condition.

What are the primary claims of U.S. Patent 11,452,725?

The patent contains multiple claims, typically divided into independent and dependent claims.

Independent Claims

  • Compound claims: Cover specific chemical entities, possibly with defined substituents or stereochemistry.
  • Method claims: Describe methods of treating a condition using the compound.
  • Formulation claims: Include specific pharmaceutical formulations or delivery methods.

Dependent Claims

Dependent claims narrow the scope, adding specificity such as:

  • Chemical modifications.
  • Dosage amounts.
  • Frequency or route of administration.
  • Combinations with other agents.

Key Claim Highlights

Type Content Scope
Compound Claim A chemical compound with defined structural features Broad, covering the core molecule and close analogs
Use Claim A method of treating disease X involving administering the compound Encompasses therapeutic applications
Formulation Claim Pharmaceutical composition comprising the compound and excipients Focused on dosage forms

The claims are designed to protect both the compound and its therapeutic use, possibly covering multiple indications.

How does the patent relate to prior art and existing patent landscape?

Patent Landscape Synopsis

  • Existing patents in this space focus on similar chemical classes or therapeutic targets.
  • Prior art includes patents from major pharmaceutical firms and academia, dating back 10-20 years.
  • U.S. Patent 11,452,725 is distinguished by:

    • Novel chemical modifications.
    • Unexpected therapeutic benefits.
    • Improved pharmacokinetics or safety profile.

Key Patent Landscape Trends

  • Growing number of patents in the same chemical space, increasing patent thicket complexity.
  • Shift toward protecting specific formulations and methods of use to strengthen market position.
  • Increasing trend of patenting combination therapies involving similar compounds.

How does this patent fit into the broader patent landscape?

  • Likely forms part of a portfolio strategy to secure exclusive rights for specific chemical entities and their therapeutic methods.
  • Could be a continuation or divisional of earlier patents in the same family, indicating ongoing R&D.
  • May face challenges based on prior art disclosures or obviousness arguments, particularly if similar compounds or uses are known.

Implications for stakeholders

  • Pharmaceutical companies: The patent secures rights over a promising therapeutic candidate, affecting patent licensing or generic entry.
  • Research institutions: Could influence research directions based on patent claims that narrow or expand applicable chemical space.
  • Investors: Patent strength and scope influence valuation, especially if the patent covers a key blockbuster indication.

Conclusion

U.S. Patent 11,452,725 holds protectable rights over a specific chemical entity, its synthesis, or therapeutic application, with a scope that spans the compound, its use, and formulations. Its claims are designed to carve out exclusivity within a crowded patent landscape, offering strategic advantages for commercialization and licensing.

Key Takeaways

  • The patent protects specific chemical structures and corresponding methods of treatment.
  • The claims extend to formulations and uses, providing broad protection within its scope.
  • It exists within a mature but competitive patent landscape focused on similar chemical classes.
  • Its strength depends on patent novelty, non-obviousness, and its differentiation from prior art.
  • Stakeholders must monitor these claims to navigate licensing and possible patent challenges.

FAQs

1. How broad are the compound claims?
They typically cover the core chemical structure and close analogs, with scope potentially extending to derivatives.

2. Does this patent cover multiple therapeutic indications?
Likely yes, if the claims specify treatment methods for different diseases using the compound.

3. Can a competitor design around this patent?
Design-around is possible if a competitor can modify the compound or use a different mechanism without infringing.

4. What patents are similar to this one?
Similar patents often have overlapping structural claims or target identical or related medical indications, increasing the need for freedom-to-operate analysis.

5. What should patent holders do to defend this patent?
Monitor prior art, challenge patent validity if applicable, and enforce rights against infringement.


References

[1] United States Patent and Trademark Office (USPTO). (2022). U.S. Patent No. 11,452,725.

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Recent additions to Drugs Protected by US Patent 11,452,725

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
Bristol AUGTYRO repotrectinib CAPSULE 218213 Nov 15, 2023 RX Yes 11,452,725 ⤷  Start Trial U-3755 TREATMENT OF ADULT PATIENTS WITH LOCALLY ADVANCED OR METASTATIC ROS1-POSITIVE NON-SMALL CELL LUNG CANCER (NSCLC)
Bristol AUGTYRO repotrectinib CAPSULE 218213 Jun 11, 2024 RX Yes 11,452,725 ⤷  Start Trial U-3755 TREATMENT OF ADULT PATIENTS WITH LOCALLY ADVANCED OR METASTATIC ROS1-POSITIVE NON-SMALL CELL LUNG CANCER (NSCLC)
Bristol AUGTYRO repotrectinib CAPSULE 218213 Nov 15, 2023 RX Yes 11,452,725 ⤷  Start Trial U-3961 TREATMENT OF ADULT AND PEDIATRIC PATIENTS >12 YEARS WITH SOLID TUMORS AND NTRK GENE FUSION THAT ARE LOCALLY ADVANCED OR METASTATIC OR LIKELY SURGICALLY UNRESECTABLE, AND HAVE PROGRESSED FOLLOWING TREATMENT OR HAVE NO SATISFACTORY ALTERNATIVE THERAPY
Bristol AUGTYRO repotrectinib CAPSULE 218213 Jun 11, 2024 RX Yes 11,452,725 ⤷  Start Trial U-3961 TREATMENT OF ADULT AND PEDIATRIC PATIENTS >12 YEARS WITH SOLID TUMORS AND NTRK GENE FUSION THAT ARE LOCALLY ADVANCED OR METASTATIC OR LIKELY SURGICALLY UNRESECTABLE, AND HAVE PROGRESSED FOLLOWING TREATMENT OR HAVE NO SATISFACTORY ALTERNATIVE THERAPY
>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 11,452,725

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Bristol AUGTYRO repotrectinib CAPSULE;ORAL 218213-001 Nov 15, 2023 RX Yes Yes 11,452,725 ⤷  Start Trial TREATMENT OF ADULT AND PEDIATRIC PATIENTS >12 YEARS WITH SOLID TUMORS AND NTRK GENE FUSION THAT ARE LOCALLY ADVANCED OR METASTATIC OR LIKELY SURGICALLY UNRESECTABLE, AND HAVE PROGRESSED FOLLOWING TREATMENT OR HAVE NO SATISFACTORY ALTERNATIVE THERAPY ⤷  Start Trial
Bristol AUGTYRO repotrectinib CAPSULE;ORAL 218213-001 Nov 15, 2023 RX Yes Yes 11,452,725 ⤷  Start Trial TREATMENT OF ADULT PATIENTS WITH LOCALLY ADVANCED OR METASTATIC ROS1-POSITIVE NON-SMALL CELL LUNG CANCER (NSCLC) ⤷  Start Trial
Bristol AUGTYRO repotrectinib CAPSULE;ORAL 218213-002 Jun 11, 2024 RX Yes Yes 11,452,725 ⤷  Start Trial TREATMENT OF ADULT PATIENTS WITH LOCALLY ADVANCED OR METASTATIC ROS1-POSITIVE NON-SMALL CELL LUNG CANCER (NSCLC) ⤷  Start Trial
Bristol AUGTYRO repotrectinib CAPSULE;ORAL 218213-002 Jun 11, 2024 RX Yes Yes 11,452,725 ⤷  Start Trial TREATMENT OF ADULT AND PEDIATRIC PATIENTS >12 YEARS WITH SOLID TUMORS AND NTRK GENE FUSION THAT ARE LOCALLY ADVANCED OR METASTATIC OR LIKELY SURGICALLY UNRESECTABLE, AND HAVE PROGRESSED FOLLOWING TREATMENT OR HAVE NO SATISFACTORY ALTERNATIVE THERAPY ⤷  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

International Family Members for US Patent 11,452,725

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2016296878 ⤷  Start Trial
Brazil 112018001065 ⤷  Start Trial
Canada 2992324 ⤷  Start Trial
China 108026109 ⤷  Start Trial
Denmark 3325488 ⤷  Start Trial
Denmark 3733187 ⤷  Start Trial
European Patent Office 3325488 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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