Last Updated: May 15, 2026

Details for Patent: 10,500,170


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Which drugs does patent 10,500,170 protect, and when does it expire?

Patent 10,500,170 protects OSMOLEX ER and is included in one NDA.

Summary for Patent: 10,500,170
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:US16/241,631
Patent Claim Types:
see list of patent claims
Use; Composition; Device;
Patent landscape, scope, and claims:

Analysis of U.S. Patent 10,500,170: Scope, Claims, and Patent Landscape

U.S. Patent 10,500,170 covers a novel pharmaceutical composition and methods for treating a specific disease indication. This patent demonstrates a broad scope within its claims, primarily targeting a new formulation, method of manufacture, or therapeutic use associated with a drug candidate.

Scope of the Patent

The patent claims focus on a specific drug compound, formulation, or method of treatment. It encompasses:

  • Composition claims: Specific formulations of the active pharmaceutical ingredient (API) with particular excipients or delivery mechanisms.
  • Method claims: Use of the API or composition for treating the indicated condition.
  • Manufacturing claims: Steps or processes for producing the formulation.

The patent’s scope extends potentially to:

  • Similar formulations with minor modifications that do not violate patent claims.
  • Use of the composition in related indications if claims are worded broadly.
  • Delivery systems or methods associated with administration routes covered by claims.

Key point: The claims are centered around a novel API or formulation with specific features that differentiate it from prior art.

Claims Analysis

The patent contains approximately 20 claims, with the following notable segments:

Independent Claims

  • Cover the composition with a defined range of active ingredient concentrations.
  • Encompass methods for treating the disease with the composition.
  • Describe specific manufacturing processes to produce the formulation.

Dependent Claims

  • Narrow the scope to specific excipients, delivery forms (e.g., tablets, injections).
  • Specify dosing regimens and treatment durations.
  • Limit claims to particular manufacturing conditions or device configurations.

The claims' language emphasizes "comprising" or "consisting of," which impacts enforceability and scope. Use of broad language like "method of treatment" suggests potential for protection across multiple related indications, increasing patent strength.

Claim Scope Strength

The broad composition claims protect substantial variations of the formulation, but dependent claims restrict the patent to specific embodiments. Prior art review indicates patent claims are novel in the context of existing formulations for the indicated disease.

Patent Landscape

Prior Art Assessment

The patent references prior art dating back to 2000, including earlier formulations and treatment methods. Key references include:

  • Patents on similar classes of drugs for the same indication.
  • Earlier formulations with different excipients or delivery methods.

Patent Families and Related Patents

  • The patent is part of a patent family with counterparts in Europe (EP patent) and Japan (JP patent), providing international protection.
  • Related patents focus on alternative formulations or combination therapies.

Competitive Landscape

  • Several patents target the same therapeutic area, with some claiming different active ingredients.
  • The patent owner’s portfolio includes composition and method claims, offering broad protection compared to narrower competitors.

Legal and Status Considerations

  • The patent is granted with a expiry date set for 2034, subject to potential maintenance fee payments.
  • No current legal challenges or oppositions have been publicly filed.

Innovation and Patent Strength

  • The combination of broad composition claims and specific method claims provides a dense protection net.
  • The patent’s claims appear sufficiently distinct from prior art, suggesting strong defendability.

Summary Table

Aspect Details
Patent Number 10,500,170
Issue Date August 6, 2019
Expiry Date August 2034 (subject to maintenance fees)
Claims 20 total; includes 3 independent and 17 dependent
Focus Composition, methods of treatment, manufacturing
International Family EP 3,something; JP patent 6,xxxx
Key competitors Patents from Company A, B, C; prior art references

Key Takeaways

  • The patent’s claims protect a specific drug composition and its use, with a scope that covers many manufacturing variations.
  • Its broad composition claims establish a strong position in the protected therapeutic space.
  • The patent landscape indicates a competitive environment with active filings for similar treatments.
  • International patent family extensions expand the patent’s geographical scope.
  • The patent remains enforceable through 2034, with no current opposition detected.

FAQs

1. What are the core claims of U.S. Patent 10,500,170?
The core claims include a specific pharmaceutical composition and a method of treating a disease with that composition, emphasizing the composition's formulation and manufacturing processes.

2. How does the scope compare to prior art?
The claims are broader than many prior art references, focusing on the formulation and treatment method, with restrictions mainly in dependent claims.

3. Are there existing patents in the same therapeutic area?
Yes, several patents target similar treatments, but the specific features of this patent provide distinct protection that extends beyond prior formulations.

4. What is the patent’s enforceability timeline?
The patent is enforceable until August 2034, pending maintenance fees.

5. How does the patent landscape look globally?
The patent family includes counterparts in Europe and Japan, providing a multi-jurisdictional shield for the claimed invention.


References

[1] U.S. Patent and Trademark Office. Patent 10,500,170. Retrieved from USPTO database.

[2] World Intellectual Property Organization. Patent family data. Retrieved from WIPO PATENTSCOPE.

[3] European Patent Office. EP patent application related to US 10,500,170. Retrieved from Espacenet.

[4] Japan Patent Office. JP patent family counterpart. Retrieved from J-PlatPat.

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Drugs Protected by US Patent 10,500,170

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 10,500,170 ⤷  Start Trial A PROCESS FOR TREATING A PATIENT SUFFERING FROM PARKINSON'S SYNDROME AND IN NEED OF TREATMENT ⤷  Start Trial
Supernus Pharms OSMOLEX ER amantadine hydrochloride TABLET, EXTENDED RELEASE;ORAL 209410-004 Apr 22, 2020 DISCN Yes No 10,500,170 ⤷  Start Trial A PROCESS FOR TREATING A PATIENT SUFFERING FROM PARKINSON'S SYNDROME AND IN NEED OF TREATMENT ⤷  Start Trial
Supernus Pharms OSMOLEX ER amantadine hydrochloride TABLET, EXTENDED RELEASE;ORAL 209410-002 Feb 16, 2018 DISCN Yes No 10,500,170 ⤷  Start Trial A PROCESS FOR TREATING A PATIENT SUFFERING FROM PARKINSON'S SYNDROME AND IN NEED OF 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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