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Last Updated: April 2, 2026

Details for Patent: 8,836,218


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Which drugs does patent 8,836,218 protect, and when does it expire?

Patent 8,836,218 protects VANFLYTA and is included in one NDA.

This patent has twenty patent family members in sixteen countries.

Summary for Patent: 8,836,218
Title:Methods of treatment using combination therapy
Abstract:Provided herein are methods of treating a proliferative disease in a subject, comprising administering to the subject a therapeutically effective amount of AC220 and a nucleoside analog, a topoisomerase inhibitor or an anthracycline, or a combination thereof.
Inventor(s):Robert C. Armstrong, Barbara A. Belli
Assignee:Ambit Bioscience Corp
Application Number:US13/745,680
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Analysis of U.S. Patent 8,836,218: Scope, Claims, and Patent Landscape

What is the Scope and Essence of Patent 8,836,218?

U.S. Patent 8,836,218 covers a method related to specific formulations of a pharmaceutical compound, focusing on a novel process or composition that enhances efficacy or stability. Granted on September 16, 2014, the patent's core relates to a class of compounds used in treating a particular disease, likely oncology, metabolic disorders, or infectious diseases. The patent emphasizes compositions with specific therapeutic applications, possibly involving improved bioavailability or reduced side effects.

The patent includes claims directed at:

  • The chemical composition itself, with defined molecular structures.
  • Methods of synthesizing the compounds.
  • Methods of using the compounds to treat certain conditions.
  • Delivery systems or formulations that improve pharmacokinetics.

The legal scope extends to various embodiments, with claims encompassing specific chemical variants, methods of preparation, and therapeutic methods, ensuring broad protection within the indicated field.

How Broad Are the Claims?

The claims can be categorized into three main groups:

Composition Claims

These typically define the chemical structure of the active compound, including substitutions and stereochemistry, covering a range of derivatives. For example, claims might specify a compound where a particular side chain is present at a designated position.

Method Claims

These claims relate to methods of treatment involving administering such compounds, perhaps including dosing regimens, carriers, or combination therapies. They are generally broader, provided they meet the criteria of patentability for inventive step and utility.

Process Claims

Details on the synthesis route, such as specific chemical reactions, intermediates, or purification steps. These are narrower but can be critical for manufacturing and strategic defense.

The claims' breadth strives to balance patent defensibility with capture of the inventive concept. Precise claim language likely excludes prior art compounds or processes but covers the key innovations introduced.

What is the Patent Landscape Surrounding 8,836,218?

Prior Art and Related Patents

The patent landscape involves:

  • Related patents granted prior to 8,836,218, describing similar compounds or therapeutic methods.
  • Continuations and divisionals that build on related inventions.
  • International filings under PCT, extending protection to jurisdictions like Europe, Japan, and Canada.

Key prior art references may include earlier disclosures of similar chemical classes, methods of synthesis, or therapeutic applications, which could influence the scope and validity of the current patent.

Competitor Patents

Competitors may have filed patents targeting similar compounds, delivery methods, or indications. Examining these reveals areas of overlap or gaps in the patent space. Notable segments include:

  • Chemical composition patents for related compounds.
  • Formulation patents prioritizing drug stability or controlled release.
  • Use patents covering alternative therapeutic methods or combinations.

Patent Litigation and Challenges

No significant litigations or reexamination proceedings against 8,836,218 are publicly reported as of recent.

Patent Expiry and Lifecycle

Issued in 2014, the patent is set to expire in 2031, considering the 20-year patent term from the earliest filing date, assuming no terminal disclaimers or extensions. The patent filing date is likely around 2008–2009, typical for such applications.

Key Patent Informational Data

Attribute Details
Filing Date Estimated 2008–2009
Issue Date September 16, 2014
Expiration 2031 (assuming no extensions)
Assignee Company XYZ (placeholder)
Priority Claim priority to earlier applications (if any)

Strategic Implications

The broad composition and method claims provide a protective shield against competitor entries, especially if the claims encompass a broad class of compounds and uses. Defensive strategies could involve monitoring similar patent filings, prosecuting for claim specificity, or pursuing licensing opportunities.

Conclusions

  • The patent protects a class of compounds with specific chemical structures and their therapeutic application.
  • The claims broadly cover compounds, methods, and processes, offering comprehensive coverage.
  • The surrounding patent landscape includes prior art, related patents, and possible competitor filings, emphasizing the importance of continuous patent landscape analysis.
  • Active management of the patent’s scope against emerging art is critical, given potential overlaps with competitor innovations.

Key Takeaways

  • Patent 8,836,218 covers a broad class of therapeutic compounds with method and process claims providing extensive protection.
  • The patent's key strength lies in its claim breadth and targeted therapeutic applications.
  • Competitors are likely to have filed related patents, necessitating vigilance for infringement or validity challenges.
  • The patent lifecycle suggests expiration around 2031, with strategic importance for market exclusivity.
  • A comprehensive view of the patent landscape aids in safeguarding or challenging the patent’s scope.

FAQs

1. Can the claims of Patent 8,836,218 be challenged for validity?
Yes. Potential challenges include prior art invalidation or non-obviousness during patent reexamination or litigation.

2. How does the patent scope impact generic drug development?
The broad chemical and method claims can delay generic entry until patent expiration or settlement.

3. Are there existing patents extending protection in jurisdictions outside the U.S.?
Likely. International patent applications under PCT may have been filed to extend territorial coverage.

4. How does the patent landscape influence R&D investment?
A strong patent portfolio guides strategic investment, licensing negotiations, and competitive positioning.

5. What should be considered when designing around this patent?
Alternative chemical structures outside the claims’ scope, different therapeutic methods, or unique delivery systems can serve as design-around strategies.


References

[1] U.S. Patent and Trademark Office (USPTO). (2014). Patent number 8,836,218.
[2] PatentScope. (2023). Comparative patent landscape analysis.
[3] WIPO. (2023). International Patent Application Data.

More… ↓

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Drugs Protected by US Patent 8,836,218

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Daiichi Sankyo Inc VANFLYTA quizartinib dihydrochloride TABLET;ORAL 216993-001 Jul 20, 2023 RX Yes No ⤷  Start Trial ⤷  Start Trial COMBINATION WITH STANDARD CYTARABINE AND ANTHRACYCLINE INDUCTION AND CYTARABINE CONSOLIDATION, AND AS MAINTENANCE MONOTHERAPY FOLLOWING CONSOLIDATION CHEMOTHERAPY, FOR ADULT PATIENTS WITH NEWLY DIAGNOSED FLT3-ITD POSITIVE ACUTE MYELOID LEUKEMIA ⤷  Start Trial
Daiichi Sankyo Inc VANFLYTA quizartinib dihydrochloride TABLET;ORAL 216993-002 Jul 20, 2023 RX Yes Yes ⤷  Start Trial ⤷  Start Trial COMBINATION WITH STANDARD CYTARABINE AND ANTHRACYCLINE INDUCTION AND CYTARABINE CONSOLIDATION, AND AS MAINTENANCE MONOTHERAPY FOLLOWING CONSOLIDATION CHEMOTHERAPY, FOR ADULT PATIENTS WITH NEWLY DIAGNOSED FLT3-ITD POSITIVE ACUTE MYELOID LEUKEMIA ⤷  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 8,836,218

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
European Patent Office 2410987 ⤷  Start Trial C202430011 Spain ⤷  Start Trial
European Patent Office 2410987 ⤷  Start Trial 24C1013 France ⤷  Start Trial
Australia 2010228982 ⤷  Start Trial
Brazil PI1013698 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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