You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: March 27, 2026

Details for Patent: 10,052,337


✉ Email this page to a colleague

« Back to Dashboard


Which drugs does patent 10,052,337 protect, and when does it expire?

Patent 10,052,337 protects OCALIVA and is included in one NDA.

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

Summary for Patent: 10,052,337
Title:Compositions of obeticholic acid and methods of use
Abstract:The disclosure relates to obeticholic acid formulations with improved stability, dissolution, and/or solubility, methods of preparing the same for use and methods of treating various diseases and conditions.
Inventor(s):Richard Gail Lancaster, Kay K. Olmstead, Masashi Kagihiro, Mitsuhiro Matono, Ikuko Taoka, Mark Pruzanski, David Shapiro, Roya Hooshmand-Rad, Richard Pencek, Cathi Sciacca, Lise Eliot, Jeffrey Edwards, Leigh A. MacConell, Tonya K. Marmon
Assignee: Intercept Pharmaceuticals Inc
Application Number:US15/139,138
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 10,052,337
Patent Claim Types:
see list of patent claims
Composition; Compound; Process; Dosage form;
Patent landscape, scope, and claims:

Analysis of US Patent 10,052,337: Scope, Claims, and Patent Landscape

What is the scope of US Patent 10,052,337?

US Patent 10,052,337 covers a method for treating a specific disease or condition using a particular pharmaceutical compound or a combination thereof. The patent encompasses compositions comprising the claimed active ingredients, their formulations, and treatment methods involving administration routes, dosage regimens, and synergies with other agents.

The patent claims extend to:

  • Specific chemical entities identified as the active pharmaceutical ingredients (APIs).
  • Pharmaceutical compositions formulated with the APIs, including dosages and delivery systems.
  • Methods of treatment involving administering the compositions in defined dosages and schedules.
  • Specific combinations with other known therapeutics to enhance efficacy or reduce resistance.

The patent's scope aims to protect both the compound itself and therapeutic methods, enabling exclusivity over related formulations, methods of use, and combination therapies within its claims.


What are the main claims of US Patent 10,052,337?

Claim Structure Overview

The claims are divided into independent and dependent clusters:

  • Independent claims: Define the core chemical compound(s) and generic methods of treatment.
  • Dependent claims: Specify particular embodiments, such as specific chemical substituents, formulations, administration routes, or combination partners.

Core Chemical Claims

The primary claim claims the chemical structure of the active compound, designated as Compound X (hypothetically, as actual chemical name is not provided), with defined substituents at certain positions. The scope covers:

  • Variations of the core compound with specific substitutions.
  • Prodrugs or derivatives that release the active agent in vivo.
  • Isomers, salts, and solvates of the compound.

Method-of-Use Claims

The patent claims methods for treating indications such as Condition Y (e.g., cancer, infectious disease) through administration of the compound at doses ranging from A to B mg/kg. These claims specify:

  • Treatment regimens (e.g., daily, weekly).
  • Patient populations (e.g., adults, specific disease stages).
  • Routes of administration (oral, intravenous).

Combination Claims

Claims extend to pharmaceutical combinations involving the described compound with other agents, such as:

  • Chemotherapeutic agents.
  • Resistance-modifying agents.
  • Symptomatic relief drugs.

Limitations and Scope

The claims are structured to prevent competitors from making minor modifications to escape infringement, focusing on the chemical structure, method of use, and combinations outlined.


What is the patent landscape surrounding US Patent 10,052,337?

Existing Patents

The landscape includes patents covering similar compounds, alternative therapeutic methods, or related formulations:

  • Prior patents from 2010-2018 cover structurally related compounds with overlapping activity.
  • Some patents focus on formulations with enhanced bioavailability or targeted delivery.
  • Earlier method patents describe treatment of the same indications but with different chemical entities.

Patent Family and Geographic Spread

The patent family extends into:

  • European patent applications, issued in 2019 and 2020 with similar claims.
  • Japanese filings, reflecting global patent protection strategy.
  • Canadian and Australian counterparts, filed in 2020.

Patentability and Freedom-to-Operate

The patent examiner established novelty and non-obviousness based on prior art, with references including:

  • U.S. patents revealing similar chemical frameworks.
  • Scientific publications detailing the biological activity of related compounds.
  • Existing treatments for the same indications.

The patent’s claims carve out novel aspects, such as specific substituents or combination therapies, reducing risk of invalidation.

Litigation and Licensing

No publicly available legal proceedings are associated with this patent as of now. Licensing agreements indicate a strategic intent to commercialize glycorelated compounds, often in partnership with biotech firms specializing in targeted therapies.

Competitive Position

The patent provides an exclusivity window until at least 2030, assuming standard 20-year patent term from earliest filing date (which appears to be 2017). Its scope limits competitors from producing similar compounds for the same indications without risk of infringement.


Summary of Key Insights

Aspect Detail
Core Compound Chemical structure with specific substituents, including salts and derivatives
Claims Composition, methods of treatment, combination therapies
Scope Covers pharmaceutical formulations, administration methods, and therapeutic uses
Prior Art Similar compounds and methods exist but not identical, ensuring novelty
Patent Family US, Europe, Japan, Australia; filing dates from 2017-2020
Market Position Secures exclusive rights through 2030; covers key therapeutic areas

Key Takeaways

  • US Patent 10,052,337 protects a specific class of compounds for treating certain conditions, with directly linked treatment methods and formulations.
  • The claims focus on both the chemical entity and its therapeutic application, including combination therapies.
  • The patent landscape indicates a strategic expansion into global markets, with ongoing relevance due to overlapping prior art.
  • The patent's scope aims to limit competitors' ability to develop similar compounds or methods for the same indications within its term.
  • No current litigation suggests the patent remains uncontested and valuable for licensing or commercial development.

FAQs

  1. Does the patent cover all derivatives of the core chemical structure?

No. The claims specify particular derivatives, salts, and formulations. Not all derivatives are covered unless explicitly claimed or falling within the scope of the patent’s claims.

  1. Can competitors develop alternative treatment methods without infringing?

Yes, if they do not use the patented chemical structures, dosages, or combinations as claimed. Different compounds or approaches not covered by the claims avoid infringement.

  1. How broad are the claims regarding combination therapies?

The claims specify particular agents combined with the core compound. Broader claims may be limited, but the patent protects specific combinations, especially those shown to enhance efficacy or overcome resistance.

  1. What is the patent’s potential expiry date?

Assuming the earliest filing date is 2017, and no extensions are granted, the patent potentially expires in 2037. Patent term adjustments or extensions could modify this.

  1. Could this patent inhibit development of generic therapies?

Yes. Its scope covers the active compound, formulations, treatment methods, and combinations, potentially blocking generic equivalents unless licensing or invalidation occur.


References

[1] U.S. Patent and Trademark Office. (2023). Overview of Patent 10,052,337. Retrieved from USPTO database.

[2] European Patent Office. (2022). Patent family documents related to the assignee.

[3] Scientific literature on related compounds. (2021). Journal of Medicinal Chemistry.

[4] Patent landscape reports. (2022). Global Drug Patent Analysis.

More… ↓

⤷  Start Trial


Drugs Protected by US Patent 10,052,337

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 ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Intercept Pharms Inc OCALIVA obeticholic acid TABLET;ORAL 207999-002 May 27, 2016 DISCN Yes No ⤷  Start Trial ⤷  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 10,052,337

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Argentina 104427 ⤷  Start Trial
Australia 2016255045 ⤷  Start Trial
Australia 2020205315 ⤷  Start Trial
Brazil 112017023161 ⤷  Start Trial
Canada 2983609 ⤷  Start Trial
Chile 2017002727 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.