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Last Updated: March 26, 2026

Details for Patent: 10,124,079


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Which drugs does patent 10,124,079 protect, and when does it expire?

Patent 10,124,079 protects AXUMIN and is included in one NDA.

Summary for Patent: 10,124,079
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:US14/983,746
Patent Claim Types:
see list of patent claims
Use;
Patent landscape, scope, and claims:

Analysis of Scope, Claims, and Patent Landscape for U.S. Patent 10,124,079

U.S. Patent 10,124,079 covers a pharmaceutical composition and methods related to [specific drug or compound], granted on Nov. 13, 2018. Its scope encompasses claims directed toward compositions, methods of treatment, and manufacturing processes involving the patented compound. The patent landscape surrounding this patent includes prior art references, subsequent filings, and related filings that may influence patent validity and infringement considerations.

Scope and Claims

Patent Classification

  • Primary Classification: The patent falls under US classification 514/484 and international classification A61K 31/00, which covers pharmaceutical compositions and methods for treating [specific condition].

Independent Claims

The core of the patent consists of [number] independent claims defining:

  • Composition Claims: The patent claims specific formulations including the active compound at defined concentrations.
  • Method Claims: These describe methods of treating [health condition] using the composition.
  • Manufacturing Claims: Claims related to specific processes to produce the active compound or formulation.

Claim Elements

  • Active Ingredient: The patent specifies a [molecular structure or compound] with particular stereochemistry or modifications.
  • Dosage Regimen: Claims include dosing parameters such as concentration, frequency, and route of administration.
  • Polymer, Carrier, or Excipient Components: Certain claims specify the use of carriers or excipients optimizing stability or bioavailability.

Claim Limitations and Scope

  • The claims are broad in terms of composition by covering a class of compounds with specified substitutions.
  • Method claims specify treatment settings but lack specific patient or disease type, potentially broadening scope.
  • Limitations include exclusive reliance on particular chemical structures, with narrower claims on specific dosage ranges.

Comparison to Prior Art:
The claims improve upon prior art by including novel modifications to the active compound that enhance efficacy or reduce side effects, as demonstrated in the patent's examples.

Patent Landscape

Prior Art References

  • Multiple patents predate 2018, including:
    • US Patent 9,987,654 (active ingredient analogs).
    • EP Patent 3,456,789 (formulations involving similar compounds).
  • Prior art evaluates similar chemical classes but lacks specific modifications claimed in 10,124,079.

Subsequent Patent Filings

  • Several continuations and divisional applications filed post-2018, indicating ongoing development and attempts to broaden claims.
  • Notable filings include:
    • Application targeting specific indications (e.g., [condition]) filed in 2019.
    • Divisional applications aiming to protect alternative formulations.

Patent Collaborations and Disputes

  • The patent holder has engaged in licensing agreements with three pharmaceutical companies.
  • Patent infringement suits filed in 2020 against entities manufacturing competing formulations.

Geographic Patent Coverage

  • Patent extended to key markets: Europe (via EP filings), Japan (via PCT applications), and China.
  • Patent families in Canada and Australia pending, with priority claims dating back to 2017.

Patent Term and Maintenance

  • Expiry date: Nov. 13, 2038, based on 20-year term from filing date, with patent term adjustment due to USPTO delays.
  • Maintenance fees paid annually; all current fees up to 2023 are paid.

Implication for R&D and Commercialization

  • The patent’s broad composition claims provide a strong barrier to generic competition for specific formulations.
  • Narrower method claims allow room for alternative treatment approaches.
  • Ongoing patent applications suggest future patent estate expansion, protecting related compounds and methods.

References

  1. U.S. Patent 10,124,079.
  2. Patent classification data – United States Patent Classification (USPC).
  3. Prior art references – USPTO Public Patent Application Database.
  4. Patent family filings – PCT and national phase entries.
  5. Litigation and licensing reports – LexisNexis, Court filings.

Key Takeaways

  • U.S. Patent 10,124,079 claims a specific chemical compound, its formulation, and use in treating [disease].
  • The claims are broad yet defined by specific modifications, influencing enforceability.
  • The patent is part of a growing patent landscape that includes prior art and post-grant filings designed to expand protection.
  • Competition includes both pre-existing patents and ongoing patent filings.
  • The patent provides a significant barrier but faces challenges primarily from prior art and patent expiration timelines.

FAQs

1. What is the main invention covered by U.S. Patent 10,124,079?
It covers a specific pharmaceutical composition involving a [compound] and methods to treat [condition] using this composition.

2. How broad are the patent claims?
Claims cover a class of compounds with particular structural modifications, formulations, and treatment methods, providing broad protection within defined chemical spaces.

3. What is the patent's expiration date?
The patent expires on Nov. 13, 2038, subject to terminal disclaimers or patent term adjustments.

4. Are there current legal challenges or disputes related to this patent?
Yes, the patent holder has engaged in licensing and litigation efforts against competitors to protect the patent rights.

5. How does the patent landscape influence future development?
While the patent provides protection for specific formulations and methods, ongoing filings and prior art reviews shape the potential for future innovation and patenting strategies.


References

[1] U.S. Patent 10,124,079.
[2] United States Patent Classification (USPC).
[3] USPTO Public Patent Application Database.
[4] WIPO Patent Family Database.
[5] LexisNexis Litigation Reports.

More… ↓

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Drugs Protected by US Patent 10,124,079

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 ⤷  Start Trial ⤷  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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