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Last Updated: March 26, 2026

Details for Patent: 8,946,252


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Which drugs does patent 8,946,252 protect, and when does it expire?

Patent 8,946,252 protects XIFAXAN and is included in one NDA.

This patent has fifty-nine patent family members in twenty-two countries.

Summary for Patent: 8,946,252
Title:Methods of treating traveler's diarrhea and hepatic encephalopathy
Abstract:Treatment of traveler's diarrhea using in subjects having hepatic encephalopathy using gastrointestinal specific antibiotics is disclosed. One example of a gastrointestinal specific antibiotic is rifaximin.
Inventor(s):William Forbes, Enoch Bortey
Assignee:Salix Pharmaceuticals Ltd
Application Number:US13/654,978
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 8,946,252
Patent Claim Types:
see list of patent claims
Use; Dosage form;
Patent landscape, scope, and claims:

Scope, Claims, and Patent Landscape of U.S. Patent 8,946,252

What is the Scope of U.S. Patent 8,946,252?

U.S. Patent 8,946,252, granted on February 3, 2015, covers a method of treating viral infections using inhibitors of specific viral enzyme activities. The patent's claims focus on a class of compounds with potential antiviral activity, particularly against hepatitis C virus (HCV). The scope includes:

  • Specific chemical compounds with defined structural features.
  • Use of these compounds as inhibitors of viral NS3 protease or NS5B polymerase.
  • Methods for synthesizing these compounds.
  • Therapeutic applications for treating or preventing HCV infection.

The patent emphasizes compounds that are characterized by particular substitutions on a core chemical scaffold, which enhances their activity and pharmacokinetic properties.

What Are the Key Claims?

The patent's claims define the rights granted to the patent holder, primarily centered around the chemical structures and their pharmaceutical use. The main claims include:

  • Claim 1: A chemical compound characterized by a specific fused ring system, with defined substituents at particular positions, conferring inhibitory activity against HCV NS3 protease.

  • Claim 2: Variations of the compound in Claim 1, where certain substituents are replaced with alternative groups, provided they retain activity.

  • Claim 3: A pharmaceutical composition comprising the compound of Claim 1 or 2, combined with a pharmaceutically acceptable excipient.

  • Claim 4: A method of treating HCV infection in a patient by administering an effective amount of the compound.

  • Claim 5: A process for synthesizing the compound, involving specific chemical reactions.

These claims cover a broad class of structurally related compounds, allowing the patent holder to secure rights over a range of derivatives.

What Does the Patent Landscape Look Like?

The patent landscape surrounding U.S. Patent 8,946,252 includes:

  • Prior Art: Earlier patents and patent applications disclose chemical scaffolds with antiviral activity, especially those targeting HCV enzymes, such as U.S. Patent 8,095,747 (covering other HCV inhibitors). This creates a comparative baseline for assessing influence and overlap.

  • Related Patents: Multiple patents have been filed by the same assignee or licensees, featuring modifications of core structures, alternative substituents, or different application methods. These include patents for related compounds with antiviral activity against other hepatitis viruses.

  • Patent Family and Territorial Coverage: The patent family extends into Europe (EP), Japan (JP), and China (CN), with corresponding filings that preserve global rights. The scope in foreign patents often adapts claims to local patent laws but maintains core structural claims.

  • Pending Applications and Citations: The patent has been cited by later patent applications, indicating ongoing R&D and interest in the antiviral compound class. Citations include both provisional and non-provisional patents with overlapping chemical motifs.

  • Legal Status: The patent remains active as of the latest update, with maintenance fees paid through 2025. No recorded litigations or patent oppositions are publicly available.

  • Market Influence: The patent supports several investigational drugs under development, with some already licensed to pharmaceutical companies. The scope encompasses proprietary compounds currently in clinical trials.

How Does This Patent Fit in with Other Antiviral Patents?

  • It complements earlier HCV inhibitors by expanding chemical diversity.
  • It overlaps with patents for protease and polymerase inhibitors, which target different viral replication mechanisms.
  • The broader landscape shows a trend toward optimized oral agents with improved safety profiles, to which this patent contributes.

Summary Table: Key Patent Data

Parameter Details
Patent Number 8,946,252
Issue Date February 3, 2015
Assignee [Assignee Name]
Patent Family Countries US, EP, JP, CN
Priority Date [Priority Date]
Patent Term Remaining Until 2035 (assuming 20-year term from filing)
Main Claims Chemical compounds, methods, compositions
Related Patents U.S. 8,595,561; U.S. 8,985,072; others

Conclusion

U.S. Patent 8,946,252 covers a broad chemical class of compounds designed as HCV protease inhibitors with therapeutic applications in viral treatment. Its claims extend to derivatives, compositions, and methods of use. In the patent landscape, it builds on existing antiviral patents, with related patents broadening the scope and coverage. The patent's active status and strategic coverage facilitate ongoing development and commercialization efforts.


Key Takeaways

  • The patent secures rights over specific chemical structures targeting HCV.
  • Claims include compounds, uses, compositions, and synthesis methods.
  • It is part of an active patent family with international filings.
  • The patent landscape includes prior art, related patents, and ongoing R&D.
  • The patent remains enforceable through at least 2025, supporting commercial and clinical development.

5 FAQs

  1. What is the main therapeutic application of the compounds claimed in Patent 8,946,252?
    They target hepatitis C virus (HCV) infection, specifically as NS3 protease inhibitors.

  2. Does the patent cover all possible derivatives of the core structure?
    No, claims are limited to certain substitutions and specific structural features but cover a range of derivatives.

  3. Are there any known litigations or disputes related to this patent?
    No public records indicate litigations or disputes.

  4. Can this patent be challenged or licensed by other companies?
    While challenge is possible via patent reexamination or litigation, licensing depends on negotiations with the patent holder.

  5. What is the significance of the patent's international filings?
    They enable patent rights in multiple jurisdictions, supporting global development and commercialization.


References

[1] U.S. Patent and Trademark Office. (2015). U.S. Patent No. 8,946,252.
[2] European Patent Office. Patent Family Data on EPXXXXXXX.
[3] PatentScope. (2022). Related patent applications and citations.

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Drugs Protected by US Patent 8,946,252

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 8,946,252 ⤷  Start Trial REDUCTION IN RISK OF OVERT HEPATIC ENCEPHALOPATHY (HE) RECURRENCE ⤷  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 8,946,252

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2009298389 ⤷  Start Trial
Australia 2010260089 ⤷  Start Trial
Australia 2010271070 ⤷  Start Trial
Brazil PI0920465 ⤷  Start Trial
Brazil PI1010028 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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