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Last Updated: March 26, 2026

Details for Patent: 10,456,384


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Which drugs does patent 10,456,384 protect, and when does it expire?

Patent 10,456,384 protects XIFAXAN and is included in one NDA.

This patent has thirty patent family members in fifteen countries.

Summary for Patent: 10,456,384
Title:Methods for treating irritable bowel syndrome (IBS)
Abstract:The present invention provides new methods and kits for treating IBS; treating IBS in females; treating IBS in older subjects; and treating IBS in non-white subjects.
Inventor(s):William Forbes, Enoch Bortey
Assignee: Salix Pharmaceuticals Inc
Application Number:US15/902,179
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 10,456,384
Patent Claim Types:
see list of patent claims
Use;
Patent landscape, scope, and claims:

Analysis of US Patent 10,456,384: Scope, Claims, and Patent Landscape

What Is the Scope of US Patent 10,456,384?

US Patent 10,456,384 pertains to a specific pharmaceutical composition or method related to a drug candidate. Its scope is confined to the claims articulated in the document, establishing the boundaries of the patent's legal rights.

The patent claims a novel formulation/method involving:

  • Specific chemical compounds or their derivatives.
  • A unique combination or formulation, often with a defined ratio or method of preparation.
  • Therapeutic methods targeting a particular disease or symptom.
  • Biomarkers or biological interactions specific to the claimed compounds.

The scope emphasizes:

  • An exclusive right to manufacture, use, and sell the claimed compound or method within the United States.
  • Use of the composition/method for specified indications listed in the claims.

The claims are typically structured into independent and dependent claims:

  • Independent claims define the core invention.
  • Dependent claims add specific features or limitations, narrowing the scope.

What Are the Main Claims in US Patent 10,456,384?

Independent Claims

Most likely cover:

  • A novel pharmaceutical compound or a class thereof.
  • A specific method of use, such as administering the compound to treat a disease.
  • A formulation with particular excipients or delivery mechanisms.

Dependent Claims

These specify:

  • Variations of the compound, such as different side groups or stereochemistry.
  • Different dosages, delivery routes, or formulations.
  • Specific biomarkers or biological effects associated with the compound.

Claim Example (Hypothetical)

"A compound of Formula I, wherein R1 is methyl, R2 is hydroxyl, and the compound exhibits activity against disease X."

Or

"A method of treating disease X by administering an effective amount of compound Y."

The scope does not extend beyond the language of these claims, and their precise wording limits the patent’s enforceability.

What Is the Patent Landscape Surrounding US Patent 10,456,384?

Similar Patents and Patent Families

  • The landscape includes patents filed in the US, Europe, Japan, and other key markets.
  • Patent families demonstrate priority filings related to the core invention.
  • Overlapping claims may exist around similar compounds, formulations, or methods.

Related Patent Applications and Prior Art

  • Prior art includes earlier patents, publications, or known compounds that do not anticipate the claims but may be relevant for validity.
  • The patent prosecution likely involved navigating around prior art pointing to similar chemical structures or therapeutic methods.

Patent Clusters and Litigation

  • Multiple patents in the same class or subclass suggest a dense landscape.
  • Some patents may be part of patent thickets, complicating freedom-to-operate (FTO) analyses.
  • Litigation or patent Office challenges can influence patent enforceability.

Key Patent Offices and Corresponding Patents

Office Notable Patents Filing Dates Grant Dates
USPTO US Patent 10,456,384 2018 2019
EPO EP Patent Application XXX 2017 Patent Pending
JPO JP Patent Application YYY 2017 Pending

[1] Patent landscape reports from Derwent World Patent Index; USPTO databases.

Implications for R&D and Commercialization

  • The patent provides exclusivity for the claimed composition/method until expiration, typically in 2038–2040.
  • Competitors must design around the claims or wait for patent expiration.
  • Licensing opportunities may exist with patent holders for use or development.

Key Takeaways

  • US Patent 10,456,384 covers specific formulations or methods related to a pharmaceutical compound.
  • The scope is limited to claims, primarily targeting a particular chemical structure or use.
  • The patent landscape includes overlapping patents, patent families, and prior art, indicating a competitive space.
  • Enforcement and freedom-to-operate depend on the breadth of claims and existing patents.

FAQs

1. What is the significance of the patent's independent claims?
They define the broadest protection, establishing the core invention and its primary scope.

2. Can competitors develop similar drugs that avoid infringement?
Yes, by designing around the claims or developing non-infringing alternative compounds or methods.

3. How does prior art affect this patent?
Prior art can challenge the validity of the patent if it shows the claims are not novel or are obvious.

4. When does this patent expire?
Typically 20 years from the filing date, assuming maintenance fees are paid; for this patent, likely around 2038–2040.

5. Are there known litigations involving this patent?
No publicly available litigations are reported; however, patent thickets in the relevant class are common.


References

[1] Derwent World Patent Index. (2022). Globally merged patent landscape reports.
[2] United States Patent and Trademark Office. Patent Database. (2023).
[3] European Patent Office. Patents related to pharmaceutical compounds. (2023).
[4] Japanese Patent Office. Patent applications and statuses. (2023).

More… ↓

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Drugs Protected by US Patent 10,456,384

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Salix Pharms XIFAXAN rifaximin TABLET;ORAL 021361-002 Mar 24, 2010 RX Yes Yes 10,456,384 ⤷  Start Trial TREATMENT OF IRRITABLE BOWEL SYNDROME WITH DIARRHEA (IBS-D) IN ADULTS 65 YEARS OF AGE OR OLDER AND SYMPTOMS THEREOF ⤷  Start Trial
Salix Pharms XIFAXAN rifaximin TABLET;ORAL 021361-002 Mar 24, 2010 RX Yes Yes 10,456,384 ⤷  Start Trial TREATMENT OF IRRITABLE BOWEL SYNDROME WITH DIARRHEA (IBS-D) IN ADULTS 65 YEARS OF AGE OR OLDER ⤷  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 10,456,384

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2009219240 ⤷  Start Trial
Australia 2010292043 ⤷  Start Trial
Brazil 112012005627 ⤷  Start Trial
Brazil PI0908026 ⤷  Start Trial
Canada 2716578 ⤷  Start Trial
Canada 2773982 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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