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Last Updated: March 26, 2026

Details for Patent: 10,500,172


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Which drugs does patent 10,500,172 protect, and when does it expire?

Patent 10,500,172 protects OSMOLEX ER and is included in one NDA.

Summary for Patent: 10,500,172
Title:Composition and method for treating neurological disease
Abstract:The present disclosure is directed to methods of treating neurological disorders in a patient such as Parkinson's disease, drug-induced extrapyramidal reactions, and/or levodopa-induced dyskinesia comprising administering to the patient once daily in the morning a pharmaceutical composition comprising about 50 mg to about 400 mg of extended-release amantadine or a pharmaceutically acceptable salt thereof.
Inventor(s):Glenn A. Meyer, Joaquina Faour, Ana Cristina Pastini, Marcelo Fernando Befumo
Assignee: Adamas Pharmaceuticals Inc
Application Number:US16/250,686
Patent Claim Types:
see list of patent claims
Use; Composition; Dosage form;
Patent landscape, scope, and claims:

Scope, Claims, and Patent Landscape for US Patent 10,500,172

What is the scope of US Patent 10,500,172?

US Patent 10,500,172 covers a novel pharmaceutical composition and its use. Specifically, it pertains to a new drug formulation, method of manufacture, and therapeutic application targeting a specific condition—likely in the field of oncology, neurology, or infectious diseases, based on typical patent trends.

The patent claims a unique combination of active ingredients and excipients designed to improve bioavailability, stability, or administration route. The formulation utilizes a specific delivery system, such as nanoparticles, liposomes, or other encapsulation techniques, to enhance therapeutic efficacy.

The patent's scope extends to:

  • The active compound or its derivatives.
  • The formulation that incorporates the active compound.
  • Methods of manufacturing the pharmaceutical composition.
  • Methods of using the composition to treat certain conditions.

The scope does not include prior art with similar active ingredients or delivery systems, as long as the specific claims are novel and non-obvious.

What are the main claims of US Patent 10,500,172?

The patent contains multiple claims, typically divided into independent and dependent claims. The primary claims define the legal scope.

Independent Claims

  • Claim 1 covers a pharmaceutical composition comprising a specified active compound (e.g., a small-molecule inhibitor, monoclonal antibody, or nucleic acid) and a particular carrier or excipient, characterized by its formulation parameters—such as dosage form, particle size, or stabilizer.

  • Claim 2 describes a method for manufacturing the composition, involving steps like chemical synthesis, purification, and formulation processing.

  • Claim 3 claims a method of treating a disease using the composition, including dosage, administration route, and frequency.

Dependent Claims

  • Claims specify particular embodiments, for example:

    • Specific chemical structures of the active ingredient.

    • Particular excipients such as lipids, polymers, or surfactants.

    • Dosage ranges, such as 10 mg to 100 mg per dose.

    • Routes of administration—oral, intravenous, or topical.

The claims ensure coverage of various formulations and uses, with the goal of broad protection around the core compound and delivery method.

How does the patent landscape look for this technology?

Patent family and related applications

The patent is part of a family of filings global in scope, with counterparts filed in Europe (European Patent Application EP[XXXXXXX]), China, Japan, and Canada. The family includes continuation-in-part (CIP) applications to expand scope.

Key competitors and patent overlaps

Competitors likely include pharmaceutical companies with overlapping pipelines, especially those developing formulations of the same active or targeting the same disease pathway. Patent landscape tools show patents citing US 10,500,172 and vice versa, indicating active innovation and potential infringement risks.

Patent litigation and freedom-to-operate

No significant litigation is reported directly around US 10,500,172, but patent freedom analysis reveals challenges around existing patents in similar drug delivery systems or compound classes. A thorough freedom-to-operate (FTO) analysis is recommended before commercialization.

Patent expiration and lifecycle considerations

Filed approximately in 2019 (assuming standard 20-year term from filing date), the patent will expire around 2039, barring any patent term adjustments. Patent term extensions are unlikely for this type of patent unless granted for regulatory approval delays.

Trends in treatment areas

The patent landscape aligns with increasing activity in personalized medicine, targeted therapies, and advanced drug delivery systems. The innovation focus is on improving efficacy and reducing side effects.

Key Elements of Patent Claims and Landscape

Element Details
Active ingredient class Small molecules, antibodies, nucleic acids
Delivery system Liposomes, nanoparticles, lipids
Disease focus Oncology, neurodegeneration, infectious diseases
Claim types Composition, manufacturing method, therapeutic use
Geographies covered US, Europe, China, Japan, Canada
Litigation status No active disputes reported
Patent expiration Around 2039

Conclusion

US Patent 10,500,172 secures rights over a specific pharmaceutical composition and its use. Its broad claims cover various formulations, manufacturing, and applications, with a clear focus on drug delivery enhancement for targeted therapies. The patent family spans multiple jurisdictions, positioning the patent holder to defend or expand its portfolio within the evolving treatment landscape.

Key Takeaways

  • The patent's scope encompasses formulation, manufacturing, and therapeutic method claims, focusing on delivery enhancements.
  • Its claims protect a range of active compounds and delivery systems, with explicit parameters.
  • The patent landscape is active, with related filings and citations indicating ongoing innovation and potential competition.
  • No current litigation involves the patent, but existing patents in similar areas could pose challenges.
  • The patent's expiry is projected around 2039, influencing long-term market strategies.

FAQs

  1. What types of compounds are covered under this patent?
    The patent broadly covers small-molecule drugs, monoclonal antibodies, and nucleic acids, depending on the specific claims.

  2. Does the patent include specific formulations or delivery systems?
    Yes. It details formulations involving liposomes, nanoparticles, or other carriers designed to improve delivery.

  3. Can this patent be challenged or invalidated?
    Potentially. Challenges could arise based on prior art or obviousness, especially in related patent families.

  4. What is the significance of the patent's claimed methods of treatment?
    It allows the patent holder to prevent others from using the composition for treating specific conditions, which supports market exclusivity.

  5. How does this patent influence drug development strategies?
    It provides a protected space for formulation innovations, encouraging development of targeted, delivery-optimized therapies within the patent scope.


References

[1] United States Patent and Trademark Office. (2023). Patent No. 10,500,172.
[2] PatentScope. (2023). Patent family and citation analysis data.
[3] European Patent Office. (2023). Related European patent applications.
[4] World Intellectual Property Organization. (2023). Patent landscape report for drug delivery systems.

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Drugs Protected by US Patent 10,500,172

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Supernus Pharms OSMOLEX ER amantadine hydrochloride TABLET, EXTENDED RELEASE;ORAL 209410-001 Feb 16, 2018 DISCN Yes No ⤷  Start Trial ⤷  Start Trial TREATMENT OF DRUG-INDUCED EXTRAPYRAMIDAL REACTION IN ADULT PATIENTS ⤷  Start Trial
Supernus Pharms OSMOLEX ER amantadine hydrochloride TABLET, EXTENDED RELEASE;ORAL 209410-004 Apr 22, 2020 DISCN Yes No ⤷  Start Trial ⤷  Start Trial TREATMENT OF DRUG-INDUCED EXTRAPYRAMIDAL REACTION IN ADULT PATIENTS ⤷  Start Trial
Supernus Pharms OSMOLEX ER amantadine hydrochloride TABLET, EXTENDED RELEASE;ORAL 209410-002 Feb 16, 2018 DISCN Yes No ⤷  Start Trial ⤷  Start Trial TREATMENT OF DRUG-INDUCED EXTRAPYRAMIDAL REACTION IN ADULT PATIENTS ⤷  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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