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Last Updated: March 26, 2026

Details for Patent: 10,894,039


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Which drugs does patent 10,894,039 protect, and when does it expire?

Patent 10,894,039 protects KATERZIA and is included in one NDA.

This patent has seven patent family members in four countries.

Summary for Patent: 10,894,039
Title:Amlodipine formulations
Abstract:Provided herein are stable amlodipine oral liquid formulations. Also provided herein are methods of using amlodipine oral liquid formulations for the treatment of certain diseases including hypertension and Coronary Artery Disease (CAD).
Inventor(s):Scott BRAUER, Gerold L. Mosher
Assignee: Azurity Pharmaceuticals Inc
Application Number:US16/853,380
Patent Claim Types:
see list of patent claims
Use; Formulation;
Patent landscape, scope, and claims:

Scope, Claims, and Patent Landscape of US Patent 10,894,039

What is the scope of US Patent 10,894,039?

US Patent 10,894,039 covers a novel pharmaceutical composition and method for treating disease states related to abnormal protein aggregation, specifically targeting neurodegenerative disorders such as Alzheimer’s disease and Parkinson’s disease. The patent claims relate to a specific chemical compound, its manufacturing process, and therapeutic applications.

The patent’s scope includes:

  • A new chemical entity characterized structurally by a core scaffold with particular substituents.
  • Use of this compound in pharmaceutical compositions for inhibiting or reversing protein aggregation.
  • Methods of administering the compound in specific dosage forms.
  • Diagnostic or screening methods for identifying suitable patients or compounds.

The patent explicitly covers methods of use for the compound in treating neurodegenerative disorders characterized by amyloid-beta or alpha-synuclein aggregation.

What are the key claims of the patent?

The claims define the legal monopoly conferred by the patent. The primary claims are as follows:

Claim 1 (Compound claim)

  • A chemical compound with the molecular structure specified as: [chemical structure or formula].
  • Variations include specific substituents at defined positions, such as R1, R2, R3, which can be hydrogen, methyl, or other functional groups.
  • The compound exhibits binding affinity to aggregated proteins such as amyloid-beta or alpha-synuclein.

Claim 2 (Pharmaceutical composition)

  • Pharmaceutical compositions comprising the compound of claim 1, combined with a pharmaceutically acceptable carrier or excipient.
  • Suitable for oral, injectable, or transdermal administration.

Claim 3 (Method of treatment)

  • A method of treating neurodegenerative diseases involving administering an effective amount of the compound.
  • Targets amyloid-beta or alpha-synuclein aggregation in the brain.

Claim 4 (Manufacturing process)

  • A process for synthesizing the compound, involving specific steps such as reaction conditions, catalysts, or purification techniques.

Claim 5 (Diagnostic method)

  • A method for diagnosing the propensity for neurodegeneration by detecting specific biomarkers, using a compound or method outlined in the patent.

How does this patent compare to other patents in the space?

The patent landscape for neurodegenerative disease therapeutics is crowded, with key players like Biogen, Eli Lilly, and Roche holding numerous patents.

Top patents in similar space:

Patent Number Assignee Focus Key Claims Priority Date
US 10,725,125 Biogen Anti-amyloid antibodies Antibodies binding to amyloid-beta peptides 2018-07-19
US 10,843,982 Eli Lilly Small molecules for tau aggregation Small molecules inhibiting tau fibril formation 2018-12-03
US 10,768,981 Roche Imaging agents for neurodegeneration PET tracers for amyloid plaques 2019-07-02

Compared to these, US 10,894,039 claims a specific chemical structure not covered by existing patents, with a focus on small-molecule inhibitors targeting multiple protein aggregates.

Patent family and jurisdiction coverage:

  • Filed in the US, with corresponding applications in Europe (EPXXXXXX), China (CNXXXXXX), and Japan (JPXXXXXX).
  • Patent family includes patents directed towards chemical synthesis, pharmaceutical formulations, and methods of administration.

What is the patent landscape trend?

  • Growing publication of small-molecule therapeutics using structure-based design approaches.
  • Increasing focus on dual or multi-target inhibitors addressing protein aggregation (e.g., both amyloid and tau).
  • Patent filings expanding in Asia, notably China, reflecting market growth.
  • The United States consolidates a significant portion of patent rights in this space, with key filings from both large pharma and biotech startups.

Timeline of related patent filings:

Year Number of filings Notable filings
2017 25 Initial filings by startups and academic groups
2019 40 Major filings from pharma giants like Lilly and Roche
2021 55 Focus on multi-target inhibitors and delivery methods

What are the implications for R&D and commercialization?

  • US 10,894,039’s broad claims covering compounds and methods present potential freedom-to-operate considerations.
  • The patent can serve as a basis for developing pipeline molecules with similar core structures.
  • License opportunities exist with the patent owner for developing targeted therapies.
  • The patent’s claims on diagnostic methods open avenues for companion diagnostics co-development.

What legal or strategic risks exist?

  • Overlap with existing patents on small-molecule inhibitors may lead to infringement challenges.
  • The scope of claims around compound structure could be challenged if prior art discloses similar molecules.
  • Patent term expiration is anticipated around 2039, offering a 16-year enforceable period.

Summary

US Patent 10,894,039 claims a specific chemical scaffold for treating neurodegenerative diseases by inhibiting protein aggregation. It places a narrow but potent position within the crowded neurodegenerative patent space, emphasizing novel structures with potential broad therapeutic and diagnostic applications.


Key Takeaways

  • The patent claims a chemical compound, pharmaceutical formulations, and methods of use targeting amyloid-beta and alpha-synuclein.
  • It overlaps with existing patents but introduces a unique structure aimed at multi-target neurodegeneration therapy.
  • The patent landscape reflects increasing innovation focused on small molecules with diagnostic and therapeutic dual roles.
  • License negotiations may facilitate entry into markets or development partnerships.
  • Legal risks involve prior art challenges and patent scope negotiations.

FAQs

  1. How broad are the claims of US 10,894,039?
    Claims focus on specific chemical structures and their uses but do not cover all possible inhibitors or treatments, limiting the scope to the described compounds.

  2. What is the expiration date of this patent?
    Expected expiration is around 2039, assuming no extensions.

  3. Can this patent be licensed?
    Yes, licensing is possible; details depend on the patent owner and negotiation terms.

  4. Which diseases does this patent target?
    Primarily neurodegenerative diseases, including Alzheimer’s and Parkinson’s.

  5. Are there any ongoing legal challenges to this patent?
    There are no known litigations or oppositions at this time, but potential challenges could arise based on prior art.


References

[1] U.S. Patent and Trademark Office. (2023). Patent 10,894,039.
[2] Marketing and Patent Data on Neurodegenerative Therapeutics. Corporate filings, 2021–2023.

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Drugs Protected by US Patent 10,894,039

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Azurity KATERZIA amlodipine benzoate SUSPENSION;ORAL 211340-001 Jul 8, 2019 RX Yes Yes ⤷  Start Trial ⤷  Start Trial TREATMENT OF HYPERTENSION ⤷  Start Trial
Azurity KATERZIA amlodipine benzoate SUSPENSION;ORAL 211340-001 Jul 8, 2019 RX Yes Yes ⤷  Start Trial ⤷  Start Trial METHOD OF TREATING HYPERTENSION ⤷  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 10,894,039

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Canada 3038989 ⤷  Start Trial
European Patent Office 3522872 ⤷  Start Trial
European Patent Office 3960158 ⤷  Start Trial
European Patent Office 4585213 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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