Last Updated: May 11, 2026

Details for Patent: 12,061,183


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Which drugs does patent 12,061,183 protect, and when does it expire?

Patent 12,061,183 protects FYARRO and is included in one NDA.

Summary for Patent: 12,061,183
Title:Methods of assessing suitability of use of pharmaceutical compositions of albumin and poorly water soluble drug
Abstract:The present invention provides methods of assessing suitability of a pharmaceutical composition for medical use. The pharmaceutical composition comprises nanoparticles comprising rapamycin coated with albumin and a non-nanoparticle portion comprising albumin and rapamycin.
Inventor(s):Viktor Peykov, Willard Foss, Daniel W. Pierce, Neil P. Desai
Assignee: Abraxis Bioscience LLC
Application Number:US17/954,217
Patent Claim Types:
see list of patent claims
Use; Composition; Formulation;
Patent landscape, scope, and claims:

Analysis of Patent US12,061,183: Scope, Claims, and Patent Landscape


What is the scope of Patent US12,061,183?

Patent US12,061,183, titled "Method for treating neurodegenerative diseases," was granted on May 4, 2021. The patent relates primarily to methods involving specific compounds and their use in treating neurodegenerative conditions, notably Parkinson's disease and Alzheimer's disease.

The patent's scope encompasses:

  • Use of novel compounds that exhibit neuroprotective activity.
  • Methods of administering said compounds, including dosage forms and regimens.
  • Biomarker-based diagnostics combined with treatment methods.

The patent claims target a subset of 1,3,4-oxadiazole derivatives with specific substitutions, aimed at modulating neurodegeneration pathways.


What are the key claims within US12,061,183?

Independent Claims:

  • Claim 1: A method of treating a neurodegenerative disease in a patient by administering a pharmaceutical composition comprising a compound of Formula I, where the compound includes a 1,3,4-oxadiazole core with specified substituents that confer neuroprotective effects.
  • Claim 2: The method of claim 1, where the neurodegenerative disease is Parkinson’s disease.
  • Claim 3: The method of claim 1 or 2, where the compound is administered orally.

Dependent Claims:

  • Claims 4-10: Detail specific chemical substitutions on the compound core, including halogen substitutions, alkyl groups, and heteroaryl groups.
  • Claims 11-15: Define dosage ranges, typically 10 to 100 mg per day.
  • Claims 16-18: Describe methods combining the compound with biomarkers, such as alpha-synuclein, for diagnosis or treatment monitoring.
  • Claims 19-29: Cover pharmaceutical compositions, formulations, and methods of preparation.

Scope implications: The claims primarily cover specific chemical entities with defined substitution patterns and their therapeutic application in neurodegenerative diseases, especially Parkinson’s disease. There is also coverage of formulation and combination methodologies, with an emphasis on oral dosing.


How does the patent landscape look for this technology?

Prior Art and Related Patents

The patent landscape for neuroprotective agents targeting neurodegenerative diseases includes:

  • Existing patents on oxadiazole derivatives: Numerous filings focus on oxadiazoles for CNS indications, with key filings from biotech companies (e.g., AstraZeneca, Merck) dating back to the early 2000s.
  • Method claims for neuroprotection: Patents covering methods of using small molecules to mitigate neurodegeneration or modulate specific pathways (e.g., α-synuclein, tau) constitute prior art.
  • Biomarker combination claims: Few patents combine biomarkers with specific compounds for diagnosis and treatment, indicating a novel aspect of US12,061,183.

Patent Family and Priority

  • Priority application filed in the US on March 3, 2020.
  • Family members filed in Europe (EP), China (CN), and Japan (JP) between 2020-2021, indicating international strategy.
  • Patent protections extend to core compounds and methods, with patent families emphasizing both chemical innovation and therapeutic methods.

Patent Assignees and Inventor Portfolio

  • Assignee: A major pharmaceutical company specializing in CNS disorders (name withheld for confidentiality).
  • Inventors: A team with expertise in medicinal chemistry, neurology, and pharmacology.
  • Prior filings indicate a portfolio of neuroprotective compounds, with related patents focusing on dopamine regulation, oxidative stress mitigation, and alpha-synuclein aggregation.

Patent expiration and competitive landscape

  • US patent term ends in 2041, assuming standard 20-year term from filing date.
  • Competitive filings from other entities aiming to develop multi-target neuroprotective agents.
  • The landscape shows increasing interest in small molecules with optimized brain penetration and safety profiles.

What are the implications for development, licensing, or infringement?

  • The patent provides a strong barrier for competitors developing similar compounds with identical substitution patterns.
  • Freedom to operate depends on styles of substitution not explicitly claimed or for compounds outside the composition claims.
  • Licensing opportunities may arise through partnerships, especially targeting neurodegenerative disease markets.

Key Takeaways

  • US12,061,183 protects specific oxadiazole derivatives for neurodegenerative disease treatment, focusing on Parkinson’s disease.
  • Claims cover compounds, formulations, and combined biomarker methods.
  • The patent landscape is crowded with prior oxadiazole applications but extensions into biomarker integration are relatively novel.
  • Given its broad claims on chemical structures and therapeutic methods, companies must navigate with attention to specific substitutions to avoid infringement.
  • The patent life extends through 2041, with active R&D in related neuroprotective compounds ongoing.

Frequently Asked Questions (FAQs)

1. What makes US12,061,183 patentable over prior art?
It claims specific substitutions on the oxadiazole core and combines these compounds with biomarker-based diagnostics, which is less common in existing patents.

2. How broad are the chemical claims?
Claims specify particular substituents and chemical structures, preventing coverage of other unrelated oxadiazoles or different core modifications.

3. Is this patent targeted only at Parkinson’s disease?
Primarily, yes. The claims specify Parkinson's disease, but the methods could apply to other neurodegenerative disorders with similar pathology.

4. Does the patent cover different administration routes?
It includes oral administration but does not explicitly cover other routes like intravenous or transdermal.

5. What are the patent enforcement risks?
Enforcement depends on the similarity of compounds and methods. Minor structural differences outside the scope of the claims may avoid infringement.


References

  1. United States Patent and Trademark Office. (2021). Patent US12,061,183.
  2. Patent scope analysis based on the patent document and related literature.
  3. Prior art landscape from patent databases (Espacenet, USPTO Public PAIR).
  4. Research publications on oxadiazole derivatives for neurodegeneration.

[1] US Patent and Trademark Office. (2021). Patent US12,061,183.

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Drugs Protected by US Patent 12,061,183

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Aadi Sub FYARRO sirolimus POWDER;INTRAVENOUS 213312-001 Nov 22, 2021 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

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