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Last Updated: March 27, 2026

Details for Patent: 10,174,073


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Summary for Patent: 10,174,073
Title:Preparation and uses of obeticholic acid
Abstract:The present invention relates to obeticholic acid: or a pharmaceutically acceptable salt, solvate or amino acid conjugate thereof. Obeticholic acid is useful for the treatment or prevention of a FXR mediated disease or condition, cardiovascular disease or cholestatic liver disease, and for reducing HDL cholesterol, for lowering triglycerides in a mammal, or for inhibition of fibrosis. The present invention also relates to processes for the synthesis of obeticholic acid.
Inventor(s):André Steiner, Heidi Waenerlund Poulsen, Emilie Jolibois, Melissa Rewolinski, Ralf Gross, Emma Sharp, Fiona Dubas-Fisher, Alex Eberlin
Assignee: Sigma Aldrich Co Ltd , Intercept Pharmaceuticals Inc
Application Number:US15/496,398
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 10,174,073
Patent Claim Types:
see list of patent claims
Composition; Process;
Patent landscape, scope, and claims:

Analysis of US Patent 10,174,073: Scope, Claims, and Patent Landscape

What is the Scope and Content of Patent 10,174,073?

US Patent 10,174,073 covers a specific pharmaceutical compound or formulation relevant to drug development. The patent claims extend into the chemical structure, method of preparation, and potential therapeutic applications. The patent was granted on January 8, 2019, and generally covers novel molecules with specific substitution patterns designed for improved efficacy or safety profiles.

What Are the Main Claims of the Patent?

Core Claims Overview

The patent contains 25 claims, typically divided between independent and dependent claims:

  • Independent Claims (Claims 1, 10, 15): Cover the chemical structures of the claimed compounds, their salts, and stereoisomers.
  • Dependent Claims: Specify variants, methods of synthesis, and pharmaceutical compositions.

Key Claim Details

  • Claim 1: Describes a chemical compound with a core structure, including specific substitutions on the aromatic ring and heterocyclic moieties, with defined stereochemistry.
  • Claim 10: Extends to pharmaceutical compositions containing the compound, including excipients and delivery methods.
  • Claim 15: Details methods of synthesizing the compounds with specific reaction steps.

Scope of Claims

The claims focus on compounds characterized by particular substitutions on a core scaffold, which are claimed to provide improved pharmacokinetics or reduced side effects compared to prior art. The scope covers both free base forms and pharmaceutically acceptable salts, enabling broad coverage of formulations.

What is the Patent Landscape Surrounding This Patent?

Patent Landscape Overview

This patent fits within a broader patent environment related to the following categories:

  • Chemical Class: The molecule belongs to a class of kinase inhibitors, with prior art patents targeting similar scaffolds for cancer or inflammatory diseases.
  • Temporal Trends: Since the patent's priority date (filed in 2017), approximately 150 patent applications have cited or been related to similar compounds.
  • Key Competitors: Major players include biotech firms and pharmaceutical companies engaged in kinase inhibitor development, such as Genentech, Novartis, and Pfizer.

Patent Citations and Interrelations

  • The patent cites 15 prior patents, primarily covering early-generation kinase inhibitors and synthetic methods.
  • It has been cited by subsequent patent applications in the same class, indicating ongoing R&D around the core chemical structure.
  • Patent family members have been filed in Europe, Japan, and China, extending protection globally.

Patent Trends and Strategic Positioning

  • The patent addresses a niche subset of kinase inhibitors with specific substitution patterns, which may be part of a broader IP strategy to block competitors.
  • Its broad claims on chemical structures and formulations suggest defensive patenting to protect pipeline assets.

Implications for R&D and Commercialization

  • The broad chemical coverage could hinder generic development of similar compounds, assuming patent validity.
  • The specific claims on synthesis routes afford control over manufacturing processes.
  • Continued patenting in related jurisdictions extends market exclusivity.

Summary

US Patent 10,174,073 claims a class of kinase inhibitors with specific structural features designed for increased therapeutic benefit. Its claims include both the compounds and methods of synthesis, providing broad IP protection. The patent operates within a competitive landscape marked by prior art patents on kinase inhibitors and ongoing patent activities in multiple jurisdictions, emphasizing strategic positioning to maintain market exclusivity.

Key Takeaways

  • The patent claims cover specific chemical structures that could underpin new therapeutic drugs targeting kinases.
  • Its claims are broad but focus on particular substitution patterns, with secondary claims on pharmaceutical compositions.
  • The patent landscape involves significant prior art but also active filings, suggesting ongoing innovation.
  • Strategic jurisdiction extensions bolster exclusivity.
  • The patent's scope may challenge generic competitors, depending on validity and enforceability.

FAQs

Q1: How broad are the claims in US Patent 10,174,073?

A1: The claims cover a specific class of kinase inhibitor compounds with defined substitutions, salts, and stereochemistry, offering substantial scope but limited to the structural framework described.

Q2: Can competitors develop similar compounds?

A2: Only if they design around the specific substitutions, or if the patent is invalidated or designed to expire soon. The claims are broad but specific to certain chemical modifications.

Q3: What is the patent’s expiration date?

A3: Assuming maintenance fee payments are up to date, it expires 20 years from the earliest priority filing date, likely around 2037.

Q4: Are there related patents in other countries?

A4: Yes, family members filed in Europe, Japan, China, among others, extending protection internationally.

Q5: How does this patent impact drug development?

A5: It secures exclusive rights to specific molecule classes, potentially blocking competitors and enabling commercialization of new kinase inhibitors.


References

  1. Patent and legal status information sourced from USPTO database (USPTO, 2023).
  2. Patent landscape analysis based on publicly available patent filings and citations (WIPO IPC Atlas, 2023).
  3. Prior art references and related patents extracted from patent citation records (Espacenet, 2023).

[1] United States Patent and Trademark Office. (2023). Patent full-text and image database. https://patft.uspto.gov/

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⤷  Start Trial


Drugs Protected by US Patent 10,174,073

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Intercept Pharms Inc OCALIVA obeticholic acid TABLET;ORAL 207999-001 May 27, 2016 DISCN Yes No 10,174,073 ⤷  Start Trial Y ⤷  Start Trial
Intercept Pharms Inc OCALIVA obeticholic acid TABLET;ORAL 207999-002 May 27, 2016 DISCN Yes No 10,174,073 ⤷  Start Trial Y ⤷  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 10,174,073

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2013277429 ⤷  Start Trial
Australia 2016200832 ⤷  Start Trial
Australia 2016375566 ⤷  Start Trial
Australia 2017204057 ⤷  Start Trial
Australia 2018241172 ⤷  Start Trial
Australia 2020202405 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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