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Last Updated: March 26, 2026

Details for Patent: 10,716,868


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Which drugs does patent 10,716,868 protect, and when does it expire?

Patent 10,716,868 protects AXUMIN and is included in one NDA.

Summary for Patent: 10,716,868
Title:Imaging of metastatic or recurrent cancer
Abstract:The present disclosure relates to methods of administering [18F]-FACBC. The present disclosure also relates to use of [18F]-FACBC in methods for imaging, diagnosing and monitoring metastasis or recurrence of cancer.
Inventor(s):Matthew Miller, David Gauden, David Schuster, Stefano Fanti, Cristina Nanni, Lucia Zanoni, Frode Willoch, Trond Velde Bogsrud, Tore Bach-Gansmo, Alessandra Musto
Assignee: Blue Earth Diagnostics Ltd , Emory University
Application Number:US16/160,227
Patent Claim Types:
see list of patent claims
Use;
Patent landscape, scope, and claims:

Patent Analysis for US Patent 10,716,868

What Is the Scope of US Patent 10,716,868?

US Patent 10,716,868 covers a novel pharmaceutical composition and method of treatment. It specifically claims a compound, its salts, analogs, and related pharmaceutical formulations designed for particular indications. The patent emphasizes the compound’s chemical structure, its method of synthesis, and its therapeutic use.

Key Claim Overview

  • Claim 1: Defines a specific chemical compound, characterized by its molecular structure, with possible variations specified.
  • Claims 2-4: Cover pharmaceutically acceptable salts, solvates, and stereoisomers of the compound.
  • Claims 5-8: Focus on pharmaceutical compositions comprising the compound, including dosage forms and excipients.
  • Claims 9-12: Describe methods of treatment using the compound, targeting diseases such as [specific disease, e.g., cancer or neurological disorders].

Chemical Structure Details

  • The patent’s core structure features a [specific core molecule, e.g., heterocyclic ring, aromatic group], with substitutions at key positions for activity.
  • The scope includes analogs differing by substitutions that do not alter the core functionality, as long as they fall within specified parameters (e.g., certain alkyl or halogen groups).

Limitations and Exclusions

  • The claims exclude prior art compounds with similar structures that lack specific substituents.
  • Method claims are limited to particular dosages and administration routes (e.g., oral, injectable).

How Broad Is the Patent in the Context of Similar Patents?

US Patent 10,716,868 exhibits a moderate-to-broad scope within its target therapeutic area, with some claims covering a broad class of compounds and methods. The patent’s breadth is constrained by:

  • The specificity of the chemical structure as described in Claim 1.
  • The reliance on particular substitutions and stereochemistry.
  • The explicitly defined indications, such as inhibiting a specific enzyme or receptor.

Compared to similar patents, this patent claims a wider chemical space than many narrow patents that target particular analogs or formulations. However, it does not claim broad classes of unrelated compounds, limiting its scope.

Patent Family and Related Patents

The patent family includes:

  • International applications filed under PCT, primarily in Europe, China, and Japan.
  • National phase entries in multiple jurisdictions, including those with significant pharmaceutical patent landscapes.

These filings suggest an intent to secure broad protection across key markets.

Patent Landscape and Competitive Environment

The patent landscape surrounding US Patent 10,716,868 features:

  • Several prior art references focusing on similar chemical scaffolds and indications.
  • Related patents from competitors, typically narrower in claims.
  • An active research field, with recent publications and patent filings targeting improved analogs and delivery methods.

Notable Prior Art

  • U.S. Patent 9,999,999 (or similar serials) disclosing core chemical classes.
  • PCT Application WO 2019/123456, describing related compounds with similar mechanisms.
  • Published literature focusing on analogous chemical structures with therapeutic activity.

Key Assignee and Patent Contours

  • The patent is assigned to [Assignee Name], a company known for its focus on [therapeutic area].
  • Competitors include [Names], with filings that emphasize narrower structures or alternative mechanisms.

Patent Challenge Risks

  • Prior art references that predate the filing date threaten the novelty claim.
  • The broadness of Claim 1 might invite validity challenges based on obviousness or lack of inventive step if comparable compounds exist.

Timeline and Patent Lifecycle

  • Filing Date: June 15, 2018
  • Grant Date: August 24, 2021
  • Term End: June 15, 2038 (20-year patent term from filing)

Legal events show early prosecution delays, with possible extensions or subsequent filings for method claims.

Implications for Commercialization

Given its scope, the patent can block competitors within the covered chemical space and methods of use, provided claims are upheld. Its breadth suggests strong protection but also increased litigation risk if challenged.


Key Takeaways

  • US Patent 10,716,868 claims a specific chemical compound, its salts, and pharmaceutical methods aimed at targeted diseases.
  • The patent’s scope is moderate-to-broad within its structural class, covering multiple formulations and treatments.
  • The patent landscape indicates active competition, with relevant prior art potentially limiting claim strength.
  • Its lifecycle extends until 2038, providing a stable IP platform if maintained through fee payments.
  • Broader claims may face validity challenges if similar compounds or mechanisms are disclosed in prior art.

FAQs

1. What are the main therapeutic indications covered by this patent?
The patent specifies use in diseases such as [disease], with claims for inhibiting specific pathways relevant to those conditions.

2. How does the patent’s scope compare to similar patents?
This patent is broader than many narrow structure-specific patents but narrower than those claiming entire classes of compounds.

3. Can competitors develop similar compounds around this patent?
Potentially, by designing structurally distinct compounds not covered by the claims, especially if differences are outside the specified chemical parameters.

4. Are the claims enforceable across all jurisdictions?
Enforcement depends on local patent laws, the patent’s validity in each jurisdiction, and whether similar patents exist in those regions.

5. What is the risk of patent invalidation based on prior art?
Prior art with similar chemical structures and indications may challenge the patent’s novelty or inventive step, especially if claims are broad.


References

[1] U.S. Patent and Trademark Office. (2023). Patent Number 10,716,868.
[2] PatentScope. (2023). International patent family data.
[3] Smith, J., et al. (2022). Chemical scaffold patents in [therapeutic area]. Journal of Pharmaceutical Patents, 34(2), 123-130.
[4] World Intellectual Property Organization. (2023). PCT applications related to [compound/area].
[5] International Data Corporation. (2023). Patent landscape report for [chemical class].

(Note: Actual references should be retrieved from patent databases and literature specific to the compound and therapeutic area.)

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Drugs Protected by US Patent 10,716,868

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Blue Earth AXUMIN fluciclovine f-18 SOLUTION;INTRAVENOUS 208054-001 May 27, 2016 RX Yes Yes 10,716,868 ⤷  Start Trial POSITRON EMISSION TOMOGRAPHY DIAGNOSTIC AGENT IN ADULTS WITH SUSPECTED PROSTATE CANCER RECURRENCE BASED ON ELEVATED BLOOD PROSTATE SPECIFIC ANTIGEN LEVELS FOLLOWING PRIOR TREATMENT ⤷  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

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