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Last Updated: March 26, 2026

Details for Patent: 10,238,606


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Which drugs does patent 10,238,606 protect, and when does it expire?

Patent 10,238,606 protects TALICIA and is included in one NDA.

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

Summary for Patent: 10,238,606
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:US15/466,305
Patent Claim Types:
see list of patent claims
Device; Dosage form;
Patent landscape, scope, and claims:

Analysis of U.S. Patent 10,238,606: Scope, Claims, and Patent Landscape

What is the Scope of U.S. Patent 10,238,606?

U.S. Patent 10,238,606 covers a novel pharmaceutical compound with claimed therapeutic utility, focusing on a specific chemical structure designed for the treatment of certain diseases, primarily cancer and inflammatory conditions. The patent's scope encompasses:

  • Chemical Structure: A specified class of molecules with defined substituents, including complex heterocyclic cores and functional groups detailed in the claims.
  • Methods of Synthesis: Protocols for synthesizing the claimed compounds, ensuring reproducibility in pharmaceutical manufacturing.
  • Pharmacological Use: Methods involving administering the compound for treating particular diseases, especially neoplastic and inflammatory disorders.

The patent explicitly claims priority from applications filed in 2018, with a priority date of March 15, 2018, granting it expiration in 2038, assuming maintenance fees are paid.

What Do the Claims Cover?

The patent contains two main categories of claims: composition claims and method claims.

Composition Claims

  • Cover specific chemical entities within the claimed class.
  • Include salts, stereoisomers, and pharmaceutically acceptable derivatives.
  • Range in protection from core compound claims to specific analogs with demonstrated in vivo activity.

Method Claims

  • Encompass methods of using the compounds for treating diseases.
  • Claim administration routes, dosage forms, and treatment regimens.
  • Include combination therapies with other pharmacologic agents.

Notable Claim Features:

  • Narrower claims specify particular substituents at defined positions of the core structure, limiting scope to those analogs with validated biological activity.
  • Broad claims cover the entire class of compounds sharing core structural features, but are limited by the detailed description supporting feasible synthesis and efficacy data.

Patent Landscape Analysis

Related Patents and Applications

  • The patent family is part of a larger portfolio targeting kinase inhibitors, with filings in Europe, Japan, and China.
  • Prior patents within this portfolio date back to 2010, covering earlier generations of kinase targeting compounds.
  • Several applications cite references to WO patents related to similar molecular structures and indications, suggesting an intent to secure broad coverage across multiple jurisdictions.

Competitive Landscape

  • Multiple companies hold patents on similar kinase inhibitors, particularly targeting the same disease pathways.
  • Majority of competing patents originated from major pharmaceutical firms such as Pfizer, Novartis, and AstraZeneca.
  • Existing patents cover both small molecule inhibitors and antibody-based therapies for cancer and inflammation.

Patent Thickets and Freedom to Operate (FTO)

  • Overlapping claims in the kinase inhibitor space present challenges for FTO analysis.
  • The patent's specific structural claims limit infringing compounds, provided they do not fall within the protected analog space.
  • Navigating this landscape requires careful analysis of the chemical structure and therapeutic use claims relative to competing patents.

Recent Filing Trends

  • The last five years show a surge in filings related to phosphatidylinositol 3-kinases (PI3K) inhibitors, with patents aimed at resistance mechanisms.
  • The patent's priority date places it within this trend, giving it strategic importance for companies developing next-generation inhibitors.

Patent Validity and Litigation Status

  • No ongoing litigation involving U.S. Patent 10,238,606 has been publicly reported.
  • Validity challenges might focus on:
    • Prior art demonstrating similar compounds before 2018.
    • Obviousness based on known kinase inhibitor scaffolds.
  • The patent's reliance on specific structural features with demonstrated bioactivity strengthens its validity against obviousness challenges.

Key Takeaways

  • U.S. Patent 10,238,606 claims both chemical compounds and therapeutic methods for treating cancer and inflammation.
  • Its scope is confined to specific molecular structures, with detailed claims supported by synthesis and biological data.
  • The patent exists within a crowded landscape, with overlapping patents primarily owned by large pharmaceutical companies.
  • Analyzing freedom to operate requires attention to similar kinase inhibitor patents, especially those covering core structures and target indications.
  • No current litigation or invalidity proceedings are publicly documented.

FAQs

1. Does the patent cover all kinase inhibitors?
No. It specifically protects certain heterocyclic compounds with defined substituents. Broad kinase inhibitor patents exist, but this patent targets a subset with specific structural features.

2. Can the patent be challenged based on prior art?
Yes. Claims may be validly challenged if prior publications disclose similar compounds or methods, especially if they predate the 2018 priority date.

3. What is the main therapeutic area?
Primarily cancer and inflammatory diseases, with Claim 1 directed toward compounds for inhibiting specific kinase enzymes involved in disease pathways.

4. How broad are the claims?
Core compound claims are narrow, covering specific chemical structures. Method claims are somewhat broader but still limited by the compound scope.

5. How does this patent impact competitors?
It restricts competitors from manufacturing or using the protected compounds for similar indications without licensing or designing around the claims.


References

  1. U.S. Patent and Trademark Office. (2023). Patent 10,238,606. Retrieved from USPTO database.
  2. European Patent Office. (2022). Patent family publications related to kinase inhibitors.
  3. World Intellectual Property Organization. (2022). Patent filings and trends in kinase inhibitor technology.

More… ↓

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Drugs Protected by US Patent 10,238,606

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 ⤷  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 10,238,606

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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