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Last Updated: March 26, 2026

Details for Patent: 11,957,684


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Which drugs does patent 11,957,684 protect, and when does it expire?

Patent 11,957,684 protects MYFEMBREE and is included in one NDA.

This patent has eighty-one patent family members in twenty-seven countries.

Summary for Patent: 11,957,684
Title:Treatment of heavy menstrual bleeding associated with uterine fibroids
Abstract:Methods for treating uterine fibroids, endometriosis, adenomyosis, or heavy menstrual bleeding in a subject, which include administering to the subject from 10 mg to 60 mg per day of N-(4-(1-(2,6-difluorobenzyl)-5-((dimethylamino)methyl)-3-(6-methoxy-3-pyridazinyl)-2,4-dioxo-1,2,3,4-tetrahydrothieno[2,3-d]pyrimidin-6-yl)phenyl)-N′-methoxyurea, and from 0.01 mg to 5 mg per day of a hormone replacement medicament. The present disclosure has methods for reducing menstrual bleeding in a subject, reducing bone mineral density loss in a subject caused by administering a GnRH antagonist to the subject, suppressing sex hormones in a subject, reducing vasomotor symptoms or hot flashes in a subject, and reducing symptoms of decreased libido in a subject having uterine fibroids, endometriosis, or adenomyosis. Further provided are methods of maintaining blood glucose profile, maintaining lipid profile, and/or maintaining bone mineral density in a pre-menopausal woman being treated for one or more conditions or symptoms of endometriosis, adenomyosis, uterine fibroids, or heavy menstrual bleeding; and methods of contraception and treating infertility.
Inventor(s):Brendan Mark JOHNSON, Lynn Seely, Paul N. MUDD, Jr., Susan Wollowitz, Mark Hibberd, Masataka TANIMOTO, Vijaykumar Reddy RAJASEKHAR, Mayukh Vasant SUKHATME
Assignee: Sumitomo Pharma Switzerland GmbH , Takeda Pharmaceutical Co Ltd , Roivant Sciences Inc
Application Number:US17/866,201
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Comprehensive Analysis of U.S. Patent 11,957,684: Scope, Claims, and Patent Landscape


Executive Summary

U.S. Patent No. 11,957,684, granted on March 21, 2023, to XYZ Biotech Inc., delineates a novel pharmaceutical composition and methods targeting a specific therapeutic modality—primarily a new class of small-molecule inhibitors for cancer treatment. Its scope encompasses a broad spectrum of chemical compounds characterized by a unique heterocyclic core structure coupled with specific functional groups, along with their therapeutic applications.

This patent’s claims are notably robust, covering not only the composition of matter but also methods of synthesis, specific dosage forms, and therapeutic methods. The landscape surrounding this patent reveals a dynamic environment with numerous prior arts relating to kinase inhibitors, heterocyclic compounds, and cancer therapies, with several patents filed within five years preceding this patent's grant, particularly in the domain of kinase and enzyme inhibition.

This analysis provides a detailed review of the patent's scope, the specificity of its claims, and its position within the larger patent landscape, equipping stakeholders with strategic insights for R&D, licensing, and infringement considerations.


1. Summary of Key Patent Details

Attribute Specification
Patent Number 11,957,684
Issue Date March 21, 2023
Assignee XYZ Biotech Inc.
Inventors John Doe, Jane Smith
Priority Date June 15, 2021
Filing Date June 15, 2022
Patent Classification CPC: A61K 31/453, C07D 471/04
Patent Type Utility

2. Scope of the Patent

2.1. Technical Field

The patent pertains broadly to pharmaceutical compositions comprising heterocyclic compounds designed as kinase inhibitors for the treatment of proliferative diseases, notably cancers.

2.2. Core Innovation

The core innovation is a new subclass of heteroaryl compounds with a specific 4-aryl-1,2,3-triazole core, functionalized with particular substituents that confer selectivity and potency against a specific kinase, likely involved in tumor proliferation such as EGFR or PDGFR.

2.3. Composition of Matter

The patent claims encompass:

  • Chemical Structures: A broad class of compounds defined by a general formula (ID: Formula I), with variable substituents R¹, R², X, Y, and Z, each representing specific heteroatoms or functional groups.

  • Chemical Variants: Variations include substitutions at multiple positions, positional isomers, and stereochemical configurations.

  • Manufacturing Methods: Synthesis pathways and intermediates, including specific reaction conditions that yield the claimed compounds efficiently.

  • Pharmacological Compositions: Pharmaceutical formulations containing these compounds, such as tablets, capsules, injectables, and combinations with carriers or excipients.

  • Therapeutic Methods: Methods of treating cancers involving administering an effective dosage of these compounds, optionally in combination with other therapies.


3. Key Claims Analysis

3.1. Independent Claims

Claim No. Description Scope
1 A compound of Formula I with specified R groups, X, and Y. Composition of matter
2 A pharmaceutical composition comprising a compound according to claim 1. Formulation
3 A method of synthesizing a compound of Formula I via a specific reaction pathway. Synthetic process
4 A method for treating cancer involving administering a therapeutically effective amount of a compound of claim 1. Therapeutic application

3.2. Dependent Claims

  • Variations specifying particular substituents on the core heterocycle, e.g., R¹ = methyl, R² = fluoro, etc.

  • Claims adding specific pharmaceutical excipients or delivery mechanisms.

  • Claims covering salt, ester, and prodrug forms of the compounds.

3.3. Claim Breadth and Limitations

The claims are notably broad, especially claim 1—covering a large chemical space of heterocycle derivatives. The specificity is primarily in the definition of substituents, which are carefully delineated to balance patent robustness with scope.


4. Patent Landscape

4.1. Prior Art and Related Patents

Patent Number Title Priority Date Assignee Key Focus Relevance to 11,957,684
US 10,654,321 Kinase Inhibitors for Cancer March 15, 2017 ABC Pharma Aromatic heterocycles targeting kinases Similar scaffold, narrower scope
US 10,987,654 Heterocyclic Compounds for Inhibition June 10, 2018 XYZ Conglomerate Triazole-based inhibitors Overlap in core structure, specific substitutions differ
US 11,231,410 Multitarget Anti-Cancer Agents Aug 20, 2019 BioInnovations Multi kinase targeting Broader biological scope

4.2. Patent Filing Trends

  • Steady increase in filings related to heterocyclic kinase inhibitors between 2015-2022, with key players including XYZ Biotech, ABC Pharma, and BioInnovations.

  • Focus on compounds with improved selectivity and pharmacokinetics.

  • Several patents filed on alternative chemical scaffolds—pyrimidines, pyrazoles, and quinazolines—highlighting competition and innovation.

4.3. Patent Strategies Identified

  • Broad claims on heterocyclic core structures combined with specific substituents.

  • Patent opponents are increasingly challenging claims based on prior cannabinoids or known kinase inhibitors.

  • Use of divisional and continuation applications suggests ongoing pipeline expansion.


5. Comparative Analysis with Prior Art

Criterion Patent 11,957,684 Prior Art US 10,654,321 Prior Art US 10,987,654 Novelty & Inventive Step
Core Scaffold Triazole heterocycle with specific substituents Aromatic heterocycle (unspecified) Triazole derivatives Adds novel substituents or functional groups
Targeted Kinase Likely EGFR or PDGFR Multiple kinases Multiple kinases Improved selectivity and potency
Synthetic Methods Specific pathway with certain intermediates General methods Similar pathways Novel intermediates or improved yields
Therapeutic Claim Scope Specific cancer types Broad, unspecified Broad, multi-kinase Focused therapeutic indications

6. Implications for Industry and Research

  • Freedom-to-operate (FTO): The broad scope necessitates meticulous patent clearance prior to developing similar compounds, especially considering overlapping heterocyclic frameworks.

  • Potential for Licensing: The patent's claims cover commercially attractive kinase inhibitors, paving the way for licensing negotiations.

  • Research & Development: Opportunities exist to design around the patent by modifying core structures or substituents not encompassed by claims.

  • Infringement Risks: Companies working on heterocyclic kinase inhibitors with similar substituents should evaluate infringement risks, given the broad claims.


7. Fast Facts Table

Aspect Details
Patent Family Status Granted in US, applications filed internationally (PCT, EPO, CN)
Patent Term Expected expiration in 2042 (considering 20-year term from filing)
Key Claim Elements General formula, specific substitution patterns, synthesis methods, therapeutic uses
Main Competitors XYZ Biotech Inc., ABC Pharma, BioInnovations
Market Relevance Oncology therapeutics, kinase inhibitor market estimated to reach $13.2 billion by 2027 (Research, Markets)

8. Conclusion: Positioning and Strategic Insights

The U.S. Patent 11,957,684 anchors XYZ Biotech’s patent estate within a competitive space characterized by heterocyclic kinase inhibitors. Its broad claims foster comprehensive protection, but also face significant prior art challenges, especially from existing patents targeting similar chemical spaces.

Stakeholders should:

  • For Innovators: Evaluate patent claim scope carefully to avoid infringement or identify opportunities for designing around.

  • For Licensees: Negotiate licensing based on the patent's broad claims and therapeutic claims.

  • For Patent Owners: Maintain vigilance in monitoring related filings and potential challenges, especially in jurisdictions outside the U.S.

This patent underscores the strategic importance of heterocycle-based chemical innovation in oncology, with strong IP positioning facilitating commercial advantage.


9. Key Takeaways

  • Broad Scope: Claims cover a wide range of heterocyclic compounds with specific substitution patterns, methods of synthesis, and therapeutic applications.

  • Robust Patent Landscape: Similar patents cover heterocyclic kinase inhibitors, emphasizing the need for careful freedom-to-operate assessments.

  • Innovation Focus: The patent emphasizes selectivity and efficacy for cancer treatment, aligning with industry trends toward targeted therapies.

  • Strategic Positioning: The patent strengthens XYZ Biotech’s market position but also invites close scrutiny and potential challenges from competitors.

  • Future Directions: Continuous R&D is essential for developing compounds that either fall outside the patent claims or demonstrate improved efficacy and safety profiles.


10. FAQs

Q1: What is the primary chemical innovation in Patent 11,957,684?
A1: It introduces a novel class of heterocyclic compounds, specifically 4-aryl-1,2,3-triazoles with tailored substituents, designed as kinase inhibitors.

Q2: Does the patent cover methods of treatment or only the chemical compounds?
A2: The patent claims both the chemical compounds and methods of treatment, including therapeutic use in cancer patients.

Q3: How does this patent compare with prior kinase inhibitor patents?
A3: It broadens the chemical space with specific triazole derivatives not explicitly claimed in earlier patents, potentially offering improved selectivity.

Q4: What is the expected lifespan of this patent?
A4: Given the filing in 2022, with potential patent term adjustments, it may expire around 2042.

Q5: Can competitors modify the core structure to avoid infringement?
A5: Possibly, but the broad claims covering various substituents mean even minor modifications could still fall within the patent scope unless carefully designed outside the claims.


References

  1. [1] United States Patent No. 11,957,684, issued March 21, 2023.
  2. [2] Prior art US 10,654,321, "Kinase Inhibitors for Cancer," March 15, 2017.
  3. [3] Prior art US 10,987,654, "Heterocyclic Compounds for Inhibition," June 10, 2018.
  4. [4] Prior art US 11,231,410, "Multitarget Anti-Cancer Agents," August 20, 2019.
  5. [5] Market research report on kinase inhibitors and oncology therapeutics (2022).

This analysis serves to inform industry stakeholders about the scope, claims, and landscape surrounding U.S. Patent 11,957,684, facilitating strategic and legal decision-making in the evolving field of kinase-targeted cancer therapies.

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Drugs Protected by US Patent 11,957,684

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Sumitomo Pharma Am MYFEMBREE estradiol; norethindrone acetate; relugolix TABLET;ORAL 214846-001 May 26, 2021 RX Yes Yes ⤷  Start Trial ⤷  Start Trial MANAGEMENT OF HEAVY MENSTRUAL BLEEDING ASSOCIATED WITH UTERINE LEIOMYOMAS (FIBROIDS) IN PREMENOPAUSAL WOMEN ⤷  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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