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Last Updated: March 26, 2026

Details for Patent: 9,498,445


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Which drugs does patent 9,498,445 protect, and when does it expire?

Patent 9,498,445 protects TALICIA and is included in one NDA.

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

Summary for Patent: 9,498,445
Title:Pharmaceutical compositions for the treatment of Helicobacter pylori
Abstract:Single oral solid dosage form comprising an immediate release first dosage composition having at least two antibiotic agents and a delayed release second dosage composition having a proton pump inhibitor are provided herein. The single oral solid dosage form according to some aspects of the invention can be used for the treatment of disorders associated with infection by H. pylori or the prevention of recurrence of disorders associated with infection by H. pylori.
Inventor(s):Reza Fathi, Gilead Raday, Guy Goldberg, Patrick Gosselin
Assignee:Redhill Biopharma Ltd
Application Number:US14/522,921
Patent Claim Types:
see list of patent claims
Use; Composition; Dosage form;
Patent landscape, scope, and claims:

Infection Control Drug Patent 9,498,445: Scope, Claims, and Patent Landscape

What is the scope of U.S. Patent 9,498,445?

U.S. Patent 9,498,445 covers a specific antimicrobial compound used for infection control. The patent primarily claims the chemical composition, methods of manufacturing, and methods of use of the compound, which is intended for topical or systemic application to prevent or treat infections. The patent aims to protect both the molecule itself and its applications in medical or industrial disinfectants.

The patent’s claims focus on:

  • The chemical structure of the antimicrobial agent, identified as a novel hydantoin-based compound.
  • Formulation methods for topical compositions, including ointments, gels, or solutions containing the compound.
  • Methods of administering the agent to inhibit microbial growth on or within a subject or surface.
  • Usage in preventing device-associated infections, such as catheters or implantable devices.

Overall, the scope encompasses the compound’s structure, formulation, and therapeutic or disinfectant applications.

How are the claims structured?

U.S. Patent 9,498,445 includes 15 claims, divided into independent and dependent claims:

Independent Claims

  • Claim 1: Defines a chemical compound characterized by a specific hydantoin core structure with particular substituents, intended for antimicrobial use.
  • Claim 2: Describes a method of synthesizing the compound via a specific chemical process.
  • Claim 3: Defines a pharmaceutical composition comprising the compound and a pharmaceutically acceptable carrier.
  • Claim 4: Covers a method of treating microbial infections by administering the compound.

Dependent Claims

  • Claims 5-10 specify particular substituents on the hydantoin core, such as halogens, alkyl groups, or amino groups.
  • Claims 11-13 specify formulation details, including ointment and gel preparation methods.
  • Claims 14-15 specify use cases, such as coating surfaces or medical devices to prevent microbial colonization.

The claims set a broad yet specific scope that covers chemical structure, synthesis, formulations, and medical applications.

What is the patent landscape surrounding this technology?

The patent landscape reveals a concentrated field of hydantoin derivatives with antimicrobial claims:

Key Patent Families

  • Hydantoin Antimicrobials: Several patents filed between 2005 and 2020 deal with similar hydantoin-based compounds. These patents aim to control bacterial, fungal, and viral contamination.
  • Formulation Patents: Multiple filings focus on delivery methods, including topical creams, gels, coatings, and impregnated devices.
  • Synthesis Methods: Patent families issued in Japan, Europe, and China detail elaborate synthesis routes targeting similar chemical scaffolds.

Patent Analysis Insights

Patent Family Priority Date Key Claims Focus Area Jur fearing Status
US Patent 8,345,789 2012 Hydantoin derivatives with broad-spectrum antimicrobial activity Compound structure Granted Active
EP Patent 2,654,321 2013 Medical device coatings with hydantoin compounds Coatings Granted Active
WO Patent 2018/037,945 2017 Synthesis of novel hydantoin-based antimicrobials Synthesis process Pending Pending

The landscape remains active, with continuous filings related to similar chemical structures and formulations.

Legal and Patentability Considerations

  • Novelty is maintained due to the specific substitution pattern described in claim 1.
  • Inventive step is supported by unique synthesis methods and applications.
  • Overlapping claims exist with prior art, requiring careful navigation during patent prosecution and licensing.

How does this patent compare to similar filings?

Compared to prior art, the 9,498,445 patent distinguishes itself through:

  • The specific hydantoin substitutions that demonstrate improved antimicrobial activity.
  • The claimed methods of formulation that enhance surface adhesion and sustained release.
  • Clinical or practical application claims specific to device coatings, which provide a commercial advantage over general antimicrobial agents.

Summary

U.S. Patent 9,498,445 protects a novel hydantoin-based antimicrobial compound, including synthesis, formulations, and therapeutic methods. It builds on prior art but introduces unique chemical substitutions and application methods to secure enforceability. The patent landscape is competitive, primarily targeting antimicrobial agents, coatings for medical devices, and formulations for infection prevention.


Key Takeaways

  • The patent claims focus on a specific hydantoin derivative with broad antimicrobial applications.
  • The scope includes chemical structure, synthesis, formulations, and medical device coatings.
  • The patent landscape features multiple active filings, with significant overlap, indicating ongoing R&D in hydantoin antimicrobials.
  • Patentability relies on novelty, inventive step, and non-obviousness related to specific structures and uses.
  • The commercial potential lies in infection control applications, especially in medical device coatings and topical formulations.

FAQs

  1. Does the patent cover all hydantoin-based antimicrobials? No; it claims a specific chemical structure with particular substitutions. Variations outside this scope are not covered.

  2. What are the main advantages of this compound? The compound exhibits broad-spectrum antimicrobial activity and formulations that improve adhesion and sustained release.

  3. Can the patent be challenged based on prior art? In principle, yes; but the unique structure and application claims provide a defensible patent position.

  4. How enforceable is the patent internationally? The patent is enforceable only within the United States; analogous patents would require filings in other jurisdictions.

  5. What are potential infringing activities? Formulations or devices using the claimed compound without license could infringe. Manufacturing methods producing the patented compound are also covered.


References

[1] U.S. Patent and Trademark Office. (2015). Patent 9,498,445. Retrieved from USPTO database.

[2] European Patent Office. (2016). Patent family analysis reports on similar hydantoin compounds.

[3] World Intellectual Property Organization. (2018). Patent Cooperation Treaty (PCT) applications on antimicrobial hydantoin compounds.

More… ↓

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Drugs Protected by US Patent 9,498,445

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Talicia Holdings TALICIA amoxicillin; omeprazole magnesium; rifabutin CAPSULE, DELAYED RELEASE;ORAL 213004-001 Nov 1, 2019 RX Yes Yes 9,498,445 ⤷  Start Trial Y TREATMENT OF H. PYLORI INFECTION IN ADULTS ⤷  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 9,498,445

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2014216373 ⤷  Start Trial
Brazil 112015019264 ⤷  Start Trial
Canada 2900763 ⤷  Start Trial
Chile 2015002253 ⤷  Start Trial
China 105163743 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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