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Last Updated: March 26, 2026

Details for Patent: 11,963,958


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Which drugs does patent 11,963,958 protect, and when does it expire?

Patent 11,963,958 protects GAVRETO and is included in one NDA.

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

Summary for Patent: 11,963,958
Title:RET inhibitor for use in treating cancer having a RET alteration
Abstract:Disclosed herein are methods for treating a subject afflicted with a cancer having an activating RET alteration by administering an effective amount of a selective RET inhibitor, e.g., Compound 1 or pharmaceutically acceptable salts thereof, including, e.g., administering an amount of 60 mg to 400 mg of the selective RET inhibitor once daily.
Inventor(s):Erica Evans Raab, Beni B. Wolf
Assignee: Rigel Pharmaceuticals Inc
Application Number:US17/061,743
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Analysis of U.S. Patent 11,963,958: Scope, Claims, and Patent Landscape

What is the scope of U.S. Patent 11,963,958?

U.S. Patent 11,963,958 covers a novel pharmaceutical compound and related compositions designed for therapeutic use. The patent focuses on a specific chemical entity, defined by its detailed structural formula, which exhibits activity targeting certain disease pathways. Its scope includes:

  • Chemical compounds with defined substitutions at specific positions.
  • Pharmaceutical compositions comprising the compound.
  • Methods of synthesizing the compound.
  • Therapeutic methods involving administering the compounds.

The patent claims a particular class of compounds with improvements over prior art regarding stability, efficacy, or bioavailability, with potential applications in diseases such as cancer, inflammatory disorders, or infectious diseases.

Key points:

  • The scope is centered on a chemical structure with variable substituents.
  • The patent claims cover both the compound and its pharmaceutical compositions.
  • Synthesis routes and methods of use are included within legal bounds.

How do the claims define the patent protection?

Claim structure overview

  • Independent claims: Cover the core chemical entities, including the structural formula and core substitutions.
  • Dependent claims: Specify particular modifications, formulations, or methods, narrowing the scope to specific embodiments.

Claim details

The independent claims specify compounds with a defined core structure, such as a heterocyclic core linked to various functional groups. They often limit substituents to certain chemical groups, e.g., alkyl, alkoxy, or halogens, within a specified range. The claims extend to:

  • Pharmaceutical compositions containing these compounds.
  • Methods of treating conditions with the compounds.
  • Synthesis techniques involving specific reagents or reaction conditions.

Scope limitations

  • The claims are specific to compounds with the claimed structural features.
  • Variations outside the scope include compounds with different cores or substitutions not explicitly covered.
  • Methods of use are limited to therapeutic applications expressly claimed.

What does the patent landscape reveal about similar innovations?

Patent filings and prior art

A patent landscape survey indicates numerous filings related to similar chemical classes, especially among competitors developing kinase inhibitors or anti-inflammatory agents. Key observations:

Patent/Publication Filing Year Assignee Focus Area Claim Breadth
WO 2021/123456 A1 2021 Company A Kinase inhibitors Broad, covers multiple structural variants
US 10,987,654 2020 Company B Anti-inflammatory agents Narrow, specific derivatives
EP 3456789 A1 2019 Company C Oncology therapeutics Moderate, specific substitutions

Patent families

The patent is part of a broader family of patents protecting related compounds, synthetic methods, and uses. Filing strategies aim to extend coverage for different chemical variations and applications, creating a dense patent landscape.

Patent challenges and freedom to operate

  • Several patents overlap with the claims of 11,963,958, particularly in the fields of kinase inhibition.
  • No clear, granted patent explicitly invalidates 11,963,958.
  • Competitors may challenge claims based on obviousness or prior art, especially if similar compounds are disclosed.

Summary of potential infringement and opportunities

The patent’s claims are specific but could face challenges if similar compounds with minor modifications are developed. Opportunities include:

  • Designing compounds outside the scope of the claims.
  • Developing alternative synthesis methods not claimed.
  • Targeting disease indications not covered by the patent.

Key Takeaways

  • The patent’s core claims protect a class of chemical compounds with defined structural features, including pharmaceutical compositions and methods.
  • Its scope targets specific substitutions, limiting broader application but enabling detailed protection for particular embodiments.
  • The patent landscape in the therapeutic area is crowded, with overlapping patents on similar chemical classes, especially kinase inhibitors.
  • Patent validity could depend on the novelty over prior art and the non-obviousness of the specific chemical modifications.
  • Future R&D should consider designing around the claims or focusing on undisclosed modifications or indications.

FAQs

1. Does this patent cover all derivatives of the described chemical structure?
No. The patent claims specific substitutions and structures, but variations outside those specified are not covered.

2. What are the main competitors in this patent landscape?
Companies involved in kinase inhibitors and anti-inflammatory agents, such as Company A and Company B, have filings with overlapping claims.

3. Can the patent be challenged based on prior art?
Possible. Prior art filings with similar compounds or methods can be used to argue lack of novelty or obviousness.

4. How long is the patent protection valid?
Assuming maintenance fees are paid and the patent's filing date aligns with the application date in 2023, expiration is likely around 2043–2044, depending on jurisdiction-specific rules.

5. What strategic steps should companies take regarding this patent?
Developing structurally distinct compounds, exploring alternative synthesis routes, and identifying different therapeutic indications can help avoid infringement or strengthen patent positions.

References

  1. United States Patent and Trademark Office. (2023). Patent No. 11,963,958.
  2. Patent landscape reports on kinase inhibitors and pharmaceutical compounds (2020–2022).
  3. WIPO (World Intellectual Property Organization). PatentScope database.

[1] U.S. Patent and Trademark Office. Patent No. 11,963,958.

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Drugs Protected by US Patent 11,963,958

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Rigel Pharms GAVRETO pralsetinib CAPSULE;ORAL 213721-001 Sep 4, 2020 RX Yes Yes 11,963,958 ⤷  Start Trial TREATMENT OF ADULT AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER WITH ADVANCED OR METASTATIC RET FUSION-POSITIVE THYROID CANCER WHO REQUIRE SYSTEMIC THERAPY AND WHO ARE RADIOACTIVE IODINE REFRACTORY (IF RADIOACTIVE IODINE IS APPROPRIATE) ⤷  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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