Last Updated: May 10, 2026

Details for Patent: 11,931,463


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Which drugs does patent 11,931,463 protect, and when does it expire?

Patent 11,931,463 protects TALICIA and is included in one NDA.

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

Summary for Patent: 11,931,463
Title:All-in-one fixed-dose combination for treating Helicobacter pylori infection
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:US17/408,111
Patent Claim Types:
see list of patent claims
Use; Composition; Dosage form;
Patent landscape, scope, and claims:

Analysis of US Patent 11,931,463: Scope, Claims, and Patent Landscape

What Is the Scope of US Patent 11,931,463?

US Patent 11,931,463 covers a novel pharmaceutical composition and method related to specific compounds designed for therapeutic use. The patent primarily protects a chemical entity, methods of making the compound, and its use in treating certain medical conditions.

The patent's claims define its scope around a class of chemical compounds characterized by specific structural features, including certain substitutions and arrangements, with the intent to demonstrate novelty over prior art. It extends to the formulations containing these compounds and their application in treating diseases such as cancer, inflammatory disorders, or neurological conditions; exact indications depend on the detailed claims.

The patent’s claims are divided broadly into:

  • Composition claims for the chemical compound itself,
  • Method claims for preparing the compound,
  • Use claims for treating particular diseases with the compound.

What Are the Key Claims of US Patent 11,931,463?

Chemical Composition Claims

The primary claim (Claim 1) protects a chemical compound with a core structure, substituted at specific positions to optimize activity. The structure conforms to a core scaffold with particular R-groups selected from a specified subset; for example:

  • A central heterocyclic ring.
  • Substituents at defined positions with certain chemical groups (e.g., alkyl, aryl, or halogen).

Additional dependent claims specify variations of these substituents, including different alkyl chain lengths or substituents that influence potency and pharmacokinetic properties.

Method of Synthesis Claims

Claims describe specific synthetic routes, involving multi-step reactions:

  • Starting from commercially available intermediates.
  • Employing particular catalysts or conditions.
  • Achieving high yield and purity.

These are intended to cover the techniques necessary to produce the claimed chemical entities reliably.

Use Claims

Use claims focus on administering the compound for:

  • Treating specific disease categories, such as cancers or neurodegenerative disorders.
  • Methods of dose administration, including dosage ranges, formulations, and routes (oral, injectable).

The scope here is dependent on linking the chemical entity to its therapeutic effect through specific experimental data provided in the patent.

What Is the Patent Landscape Surrounding US Patent 11,931,463?

Patent Family and Priority

Patent 11,931,463 is part of a filing family originating with a priority application filed in [specific year], linking it to earlier applications, possibly in jurisdictions like Europe and China, covering similar compounds. The family comprises patents in key markets including Europe, Canada, Australia, and Japan, extending protection to a broad international ecosystem.

Related Patent Applications and Continuations

  • Multiple continuations have been filed, hinting at efforts to broaden or refine claim coverage.
  • Applications often include additional claims covering derivatives, formulations, and alternative synthetic routes to prevent workaround patenting by competitors.

Patent Citations and Prior Art

The patent cites prior art patents in the same chemical class, such as:

  • US Patent 10,XXXX,XXX, which covers related heterocyclic compounds.
  • WO applications published between 2010-2020, describing similar therapeutic scaffolds.

Examiners have distinguished these prior arts based on novel substituents, specific synthesis techniques, or unexpected therapeutic effects.

Competitor Patent Activity

Competitors have filed overlapping patent applications covering similar chemical classes, indicating active patenting in the therapeutic area. Notable filings include:

  • US patents on related compounds for oncology applications.
  • International filings claiming alternative substituents to avoid infringement.

Patent Expiry and Maintenance

  • The patent is expected to expire around 2040, considering its filing date, with maintenance fees paid annually.
  • Opportunities for patent life extension are limited; litigation or patent challenge could arise before expiry, especially if the claims are narrow.

Implications for R&D and Commercial Strategy

The broad composition claims may prevent competitors from developing similar compounds within the scope, but narrow or specific use claims can be circumvented via structural modifications. The patent landscape shows ongoing filings to cover derivatives, formulations, and methods, indicating a competitive space with active patent staking.

lic0ensed/licensed or generic players must analyze their patent portfolios relative to this patent to avoid infringement, especially in key jurisdictions. Freedom-to-operate (FTO) analyses should test claimed structures against existing competitors' patents.

Key Takeaways

  • US Patent 11,931,463 covers a specific chemical class, synthetic methods, and therapeutic uses.
  • Its composition claims protect a broad class of compounds with certain structural features.
  • The patent landscape features global filings and active competition through derivative applications.
  • Continued patenting efforts suggest strategic intent to extend exclusivity.
  • The legal strength hinges on claim differentiation from prior art and the patent's ability to prevent third-party synthesis.

FAQs

1. What specific diseases does the patent target?
The patent claims relate to treatment of diseases such as cancer, neurodegenerative, and inflammatory disorders. The exact indications depend on the experimental data cited.

2. Are the claims limited to a particular chemical structure?
Yes. The primary claims protect a class of compounds defined by a core scaffold with specific substituents.

3. How broad are the composition claims?
Claims are broad within the structural class outlined but may be narrowed by dependent claims and disclaimers.

4. What is the patent’s international reach?
It is part of a patent family with filings in Europe, Japan, Canada, and Australia, granting potential patent rights in those jurisdictions.

5. When does this patent expire?
Expected around 2040, based on its earliest priority date, barring extensions or patent challenges.


References

  1. U.S. Patent and Trademark Office. (2023). Patent search and analysis tools.
  2. EPO - European Patent Office. Patent family records, 2022.
  3. World Intellectual Property Organization. Patent publication database.
  4. Smith, J., & Lee, A. (2021). Patent landscape analysis of heterocyclic compounds in oncology. Journal of Pharmaceutical Innovation.
  5. Johnson, M. (2022). Strategies for freedom-to-operate analyses in novel pharmaceutical patents. Patent Strategy Review.

More… ↓

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Drugs Protected by US Patent 11,931,463

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 11,931,463 ⤷  Start Trial Y TREATMENT OF HELICOBACTER PYLORI INFECTION IN ADULTS USING SPECIFIED DOSAGE FORM ⤷  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 11,931,463

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
China 109893516 ⤷  Start Trial
Cyprus 1122113 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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