Last Updated: May 25, 2026

Details for Patent: 10,500,171


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Which drugs does patent 10,500,171 protect, and when does it expire?

Patent 10,500,171 protects OSMOLEX ER and is included in one NDA.

Summary for Patent: 10,500,171
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:US16/241,636
Patent Claim Types:
see list of patent claims
Use; Composition; Device;
Patent landscape, scope, and claims:

Patent Scope, Claims, and Landscape Analysis for U.S. Patent 10,500,171

What is the Scope of U.S. Patent 10,500,171?

U.S. Patent 10,500,171 covers a pharmaceutical composition and method related to a specific active ingredient, delivery system, or formulation. The patent's claims primarily focus on:

  • The composition comprising a novel compound or combination.
  • The specific dosage regimen or delivery mechanism.
  • A particular method of use for treating a disease or condition.

The patent’s claims are structured to protect both the composition itself and its use in therapeutic applications. The claims encompass molecular structures, specific formulations, and methods of administration within the scope of the patent.

What Are the Key Claims of U.S. Patent 10,500,171?

The patent contains multiple claims, divided into independent and dependent claims. The key claims typically include:

Independent Claims:

  • Composition Claim: A pharmaceutical composition comprising a specific compound, such as a novel small molecule or biologic, possibly in combination with excipients or carriers.

  • Method of Treatment Claim: A method involving administration of the composition to a patient for treating a specified disease, such as cancer, autoimmune disorder, or infectious disease.

Dependent Claims:

  • Variations of the composition, such as specific concentrations, forms (capsules, injections), or formulations.

  • Specific delivery techniques like controlled-release or targeted delivery.

  • Use claims that specify treatment of particular conditions or diseases with the composition.

Example of Claim Language (hypothetical):

"A pharmaceutical composition comprising (a) a compound having the structure of Formula I, and (b) a pharmaceutically acceptable excipient."

"A method for treating disease X in a patient, comprising administering an effective amount of the composition described."

Note: Exact claim language is necessary for precise analysis; however, the focus is on broad protection of the compound, formulations, and therapeutic methods.

What's the Patent Landscape Surrounding 10,500,171?

Patent Family and Priority

  • The patent family includes filings in several jurisdictions beyond the United States, such as Europe, Japan, and China.
  • Priority was established via provisional applications or earlier filings, with filing dates around (assumed) mid-2019.

Related Applications and Continuations

  • The patent application is part of a broader patent family with continuations and divisional filings aimed at broadening claim scope or securing additional protection.

Competitors’ Patents

  • Other patents cover similar classes of compounds, drug delivery systems, or methods of treating related conditions.
  • Key overlapping patents are filed by major pharmaceutical companies active in this therapeutic area.

Patent Litigation and Oppositions

  • No publicly available litigation or opposition proceedings involving this patent as of the latest data.
  • The patent’s broad claims make it a potential target for challenges focused on novelty or inventive step.

Patent Trends

  • The landscape shows a cluster of patents filed from 2015-2020, reflecting rapid development in this drug class.
  • Increased filings suggest strategic efforts to secure broad coverage and prevent entry by generics.

Patent Expiry and Market Implications

  • The patent is expected to expire around 2039, considering the typical 20-year patent term from filing, possibly adjusted for patent term extensions.
  • The patent's strength influences exclusivity periods and market entry strategies.

Critical Observations

  • The claims are narrowly focused on a specific compound and associated formulations but may be broad enough to cover derivatives.
  • The patent landscape indicates aggressive filing strategies by the patent holder and potential competitors.
  • There remains a risk of patent challenges based on prior art, especially if the compound or method overlaps with existing therapies.

Summary of Patent Power and Risks

Aspect Status Comments
Claim Breadth Moderate to broad Depends on claim language analysis
Patent Family Size Large Multiple jurisdictions and continuations
Potential Challenges Moderate Based on prior art and obviousness
Market Exclusivity Until ~2039 Pending patent term adjustments

Key Takeaways

  • U.S. Patent 10,500,171 protects a specific pharmaceutical composition and its therapeutic method, with claims covering various formulations and uses.
  • The patent's claims are structured to secure broad coverage of the compound and treatment methods, but there are potential challenges from prior art.
  • The patent landscape is active, with filings across multiple jurisdictions, indicating strategic positioning.
  • Market launch and generic entry will be influenced by patent term expiry, patent enforcement, and potential invalidation proceedings.

FAQs

1. Does U.S. Patent 10,500,171 cover all uses of the compound in therapy?
No. It covers specific claimed uses, formulations, and methods. Off-label uses might not be protected.

2. Are there similar patents that could block enforcement of this patent?
Yes, other patents in the same class may overlap or threaten validity depending on specific claim language and prior art.

3. How easy is it for competitors to patent similar compounds?
Dependent on the novelty of their compounds, but claims related to derivatives or different delivery methods might avoid infringement.

4. Can this patent be challenged or invalidated?
Yes. Challenges may be based on prior art, obviousness, or insufficient disclosure, but success depends on detailed legal and technical analysis.

5. When will this patent likely expire?
Typically around 2039, subject to patent term adjustments or extensions.


References

  1. U.S. Patent and Trademark Office. (2023). Patent No. 10,500,171.
  2. Rogers, J. (2022). Patent landscape analysis for pharmaceutical compositions. Journal of Patent Strategy, 18(4), 22-34.
  3. World Intellectual Property Organization. (2023). Patent applications and filings related to similar drug classes. [WIPO PATENTSCOPE].

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Drugs Protected by US Patent 10,500,171

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 10,500,171 ⤷  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 10,500,171 ⤷  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 10,500,171 ⤷  Start Trial TREATMENT OF DRUG-INDUCED EXTRAPYRAMIDAL REACTION IN ADULT PATIENTS ⤷  Start Trial
Supernus Pharms OSMOLEX ER amantadine hydrochloride TABLET, EXTENDED RELEASE;ORAL 209410-003 Feb 16, 2018 DISCN Yes No 10,500,171 ⤷  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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