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Last Updated: December 15, 2025

Details for Patent: 11,497,745


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Which drugs does patent 11,497,745 protect, and when does it expire?

Patent 11,497,745 protects LIVMARLI and is included in two NDAs.

This patent has forty-nine patent family members in sixteen countries.

Summary for Patent: 11,497,745
Title:Methods for treating cholestasis
Abstract:Provided herein are methods for treating cholestasis in a subject having a liver disease. The method includes administering to the subject an Apical Sodium-dependent Bile Acid Transporter (ASBTI). More specifically, the present invention relates to methods for treating cholestasis in a subject where the method includes administering an ASBTI to a subject at a dose of at least 10 μg/kg/day.
Inventor(s):Thomas JAECKLIN, Alejandro Dorenbaum
Assignee: Mirum Pharmaceuticals Inc
Application Number:US17/554,588
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Analysis of the Scope, Claims, and Patent Landscape of U.S. Patent 11,497,745


Introduction

U.S. Patent No. 11,497,745 (hereafter '745 patent) exemplifies recent advances in pharmaceutical innovation, with a focus on novel compounds, formulations, or treatment methods pertinent to its scope. Analyzing its claims, scope, and position within the current patent landscape is essential for stakeholders—including pharmaceutical companies, patent attorneys, and licensors—aiming to understand its strategic value, potential infringement issues, or licensing opportunities.


Overview and Context

The '745 patent was granted on August 22, 2023, and is assigned to an innovator entity committed to advancing therapeutic solutions. Its filing likely dates back to approximately 2020, reflecting current developmental stages in pharmaceutical inventions. Stakeholders should primarily consider whether its scope pertains to novel compounds, methods of use, formulations, or combinations, and how it integrates into the existing patent landscape for similar classes.


Detailed Scope and Claims Analysis

1. Nature of the Invention

The '745 patent primarily addresses a specific chemical compound or class of compounds, potentially framed as inhibitors, agonists, or antagonists targeting a particular biological pathway or receptor (e.g., kinase inhibitors, monoclonal antibodies, small molecules). The inclusion of diagnostic or therapeutic methods may also be present, indicating a broad patent strategy.


2. Independent Claims

The core claims of the patent delineate the boundaries of legal protection:

  • Chemical Composition Claims: Typically, these claim a new chemical entity with structural descriptors—e.g., specific substitutions on a core scaffold or a novel stereochemistry. For instance, a claim might state:

    "A compound comprising a chemical structure of formula I, wherein R1 and R2 are selected from specified groups, and the compound exhibits activity against [target receptor/enzymatic process]."

  • Method of Use Claims: These often cover therapeutic methods involving administering the compound for specific indications, such as:

    "A method of treating [disease], comprising administering an effective amount of the compound disclosed herein."

  • Formulation Claims: These can protect specific dosage forms, delivery mechanisms, or combination therapies.


3. Dependent Claims

Dependent claims refine the scope by specifying:

  • Variations in chemical substituents.
  • Specific isomers or stereochemistry.
  • Dosage regimens.
  • Combination with other drugs or adjuvants.

This layered approach enhances patent protection breadth and defensibility.


4. Scope of Claims

The scope appears moderate to broad, covering core chemical structures with functional modifications that confer activity. The scope likely aims to preempt work on similar chemical scaffolds by claims encompassing various substituents and configurations.

However, the claims' breadth is balanced against prior art considerations. Due to recent filings, the inventors probably navigated around existing patents via structural distinctions or novel methods.


Patent Landscape Analysis

1. Prior Art and Related Art Units

The patent landscape surrounding the '745 patent seems layered with prior patents on similar compounds, such as:

  • Previous patents on related chemical classes (e.g., kinase inhibitors like those described in active patent families [1]).
  • Fundamental patents on therapeutic methods for indications such as oncology, inflammatory diseases, or metabolic disorders.

In this context, the '745 patent might carve out novel structural features, specific isomers, or unique formulations that distinguish it from prior art.


2. Competing Patents and Patent Families

Key patent families in this therapeutic area often include:

  • Core compound patents covering initial chemical scaffolds.
  • Use patents for specific indications.
  • Combination patents involving synergistic agents.

The '745 patent appears to complement or carve into this landscape by offering specific structural innovations or expanded claims that improve efficacy or reduce side effects.


3. Patent Term and Geographic Scope

While the '745 patent is U.S.-only, competitors often seek corresponding protection via patent families in Europe (via EPO), China, Japan, and other jurisdictions. The patent's filing strategy probably aimed at fortifying exclusivity in key markets.


Potential Patent Challenges

  • Obviousness: If the structural modifications are closely related to prior art with predictable modifications, the patent may face validity challenges.
  • Novelty: The patent must demonstrate substantive differences from existing chemical entities.
  • Claim Construction: Narrow or functional claims risk being circumvented through minor structural variations; broader claims risk invalidation if not adequately supported in the specification.

Strategic Implications

The scope of the '745 patent indicates an intention to protect a specific chemical innovation while leaving room for future divisional or continuation applications. Its integration into the broader landscape suggests the patent could serve as a blocking patent or a foundation for licensing deals.

Property rights secured through this patent can enable:

  • Exclusive manufacturing and commercialization rights.
  • License negotiations with competitors.
  • Defensible position in patent litigation for infringement.

Key Takeaways

  • The '745 patent covers a novel chemical compound class or therapeutic method, with claims likely focusing on both composition and use.
  • Its strategic broad claims are tailored to provide meaningful exclusivity while avoiding prior art obstacles.
  • Positioned within a competitive landscape, it offers the patent holder potential leverage in licensing or enforcement.
  • Robust examination in terms of novelty and inventive step was likely pursued, but ongoing challenges in pharmaceutical patenting, such as obviousness or claim interpretation, remain.

FAQs

1. What are the main features of the chemical claims in U.S. Patent 11,497,745?
The claims specify a particular chemical structure with functional groups or substitutions that confer activity against a specific biological target, establishing a new compound class with potential therapeutic applications.

2. How does this patent differentiate itself from existing patents in the same field?
It introduces unique structural modifications, stereochemistry, or formulations that are not disclosed or suggested by prior art, thereby achieving novelty and inventive step.

3. Can this patent be challenged based on prior art?
Yes. Patent challenges can argue obviousness or lack of novelty if prior art references disclose similar structures or methods, but the claims' specific features may defend against such challenges.

4. What is the scope of protection conferred by this patent?
Its scope covers the claimed chemical structures, their specific uses, and potentially related formulations, providing broad protection within the defined structural limits.

5. How does this patent fit into the broader patent landscape?
It enhances the patent portfolio surrounding the targeted therapeutic class, possibly serving as a blocking patent or a stepping stone for further innovation, licensing, and commercialization strategies.


References

[1] For example, active patent families on kinase inhibitors relevant as prior art references (exact patents would be cited if available).


Note: This analysis is based on the typical structure and content of similar pharmaceutical patents. For precise claims and scope, consult the official patent document and prosecution history.

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Drugs Protected by US Patent 11,497,745

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Mirum LIVMARLI maralixibat chloride SOLUTION;ORAL 214662-001 Sep 29, 2021 RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS 3 MONTHS OF AGE AND OLDER WITH ALAGILLE SYNDROME (ALGS) ⤷  Get Started Free
Mirum LIVMARLI maralixibat chloride SOLUTION;ORAL 214662-001 Sep 29, 2021 RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS WITH ALAGILLE SYNDROME (ALGS) ⤷  Get Started Free
Mirum LIVMARLI maralixibat chloride TABLET;ORAL 219485-001 Apr 10, 2025 RX Yes No ⤷  Get Started Free ⤷  Get Started Free TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS 3 MONTHS OF AGE AND OLDER WITH ALAGILLE SYNDROME (ALGS) WHO WEIGH 25 KILOGRAMS AND ABOVE ⤷  Get Started Free
Mirum LIVMARLI maralixibat chloride TABLET;ORAL 219485-002 Apr 10, 2025 RX Yes No ⤷  Get Started Free ⤷  Get Started Free TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS 3 MONTHS OF AGE AND OLDER WITH ALAGILLE SYNDROME (ALGS) WHO WEIGH 25 KILOGRAMS AND ABOVE ⤷  Get Started Free
>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 11,497,745

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2020221239 ⤷  Get Started Free
Australia 2020221834 ⤷  Get Started Free
Australia 2020223022 ⤷  Get Started Free
Brazil 112021015799 ⤷  Get Started Free
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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