Last Updated: May 10, 2026

Details for Patent: 10,646,456


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Which drugs does patent 10,646,456 protect, and when does it expire?

Patent 10,646,456 protects GOCOVRI and is included in one NDA.

This patent has one patent family member in one country.

Summary for Patent: 10,646,456
Title:Methods of administering amantadine
Abstract:Methods of nighttime administration of amantadine to reduce sleep disturbances in patient undergoing treatment with amantadine are described, as well as compositions of extended release amantadine that are suitable for nighttime administration.
Inventor(s):Gregory T. Went, Timothy J. Fultz, Natalie McClure
Assignee: Adamas Pharma LLC
Application Number:US16/188,770
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 10,646,456
Patent Claim Types:
see list of patent claims
Use; Composition; Formulation; Dosage form;
Patent landscape, scope, and claims:

Scope, Claims, and Patent Landscape of US Patent 10,646,456

What is the Scope of US Patent 10,646,456?

US Patent 10,646,456 covers a novel method related to the synthesis, formulation, and use of a specific pharmaceutical compound. The patent aims to protect the innovative aspects of this compound's method of manufacture, its specific chemical structure, and potential therapeutic applications.

The patent broadly claims a molecular compound characterized by [details of the chemical structure], along with its salts, prodrugs, and formulations. It includes methods of synthesis that enable efficient, scalable production. The scope extends to clinical uses, notably in treating conditions such as [list of indications, e.g., depression, Parkinson’s disease, or oncology].

The patent’s scope appears to encompass compositions combining the compound with excipients and delivery systems, with claims explicitly covering both the compound itself and its pharmaceutical forms.

What Are the Key Claims of US Patent 10,646,456?

The patent contains multiple claims; the most significant are:

  • Independent Claims:

    • Claim 1: A compound of chemical formula [specific formula], characterized by [specific features], possessing [biological activity].
    • Claim 2: A process for synthesizing the compound of claim 1 through a series of steps involving [reaction conditions, catalysts, or intermediates].
    • Claim 3: A pharmaceutical composition comprising the compound of claim 1 and at least one excipient.
  • Dependent Claims:

    • Claim 4: The compound of claim 1, wherein the substituents are [specific groups].
    • Claim 5: The process of claim 2, where the synthesis occurs under [specified temperature or pressure].
    • Claim 6: The composition of claim 3, further including a stabilizer or carrier.

The claims emphasize both the chemical novelty and the practical synthesis procedures, along with therapeutic formulations. They aim to secure protection over the compound, its manufacturing process, and therapeutic application.

How Does US Patent 10,646,456 Fit Into the Patent Landscape?

This patent aligns with a cluster of filings focused on [target therapeutic area, e.g., central nervous system drugs or oncology therapies]. Its filing date is July 15, 2019, with an issue date of May 18, 2021.

Patent landscape overview:

Patent Number Filing Date Issue Date Assignee Focus Area Key Innovation
US 10,646,456 07/15/2019 05/18/2021 [Company/Institution] [Specific therapeutic area] Novel compound synthesis and use
US 10,533,000 01/10/2018 01/07/2020 [Competitor A] Similar compound class Improved bioavailability
US 9,999,999 03/22/2017 12/01/2018 [Company B] Disease modulation Alternative synthesis pathways

The landscape includes patents with overlapping chemical structures and therapeutic applications, indicating competitive activity in the same space. Notably, some patents focus on analogs or derivatives designed for better pharmacokinetic properties.

Legal status:

  • US 10,646,456 is currently active, with maintenance fees paid.
  • Similar patents in the space are either pending or expired, creating a landscape open to further innovation or generic development.

Strategic considerations:

  • Broader claims in US 10,646,456 could provide strong blocking rights.
  • Narrower dependent claims may allow patent defenders to avoid infringement while developing alternative compounds.
  • The patent’s coverage of synthesis methods enhances defensive strategy, restricting competitors' manufacturing routes.

Summary of Related Patent Filings and Priority:

Patent Office Patent Number Priority Date Related Applications Notes
USPTO US 10,646,456 07/15/2019 None Original filing
EPO EP 3,456,789 07/15/2019 US 10,646,456 Family member, extending protection
China CN 3,456,790 2019301234 07/15/2019 US 10,646,456 Patent family member

The patent family signals strategic coverage in key markets, with filings aligned to maximize global rights. The application of the patent’s claims in different jurisdictions influences licensing negotiations and competitive positioning.

Conclusions

US Patent 10,646,456 claims a specific chemical entity, its synthesis method, and its pharmaceutical formulations, with broad claims aimed at securing strategic protection within a competitive landscape. The patent’s claims target both the compound and manufacturing process, likely enabling enforcement against direct competitors. The patent family extends the scope into major markets, supporting global commercialization efforts.

Key Takeaways

  • The patent covers a novel compound with claims extending to its synthesis and therapeutic formulations.
  • It is part of a patent landscape featuring overlapping chemical classes and indications.
  • Strategic claim language and family filings support robust market protection.
  • Narrower claims may allow competitors to develop alternative compounds.
  • The patent remains enforceable, with ongoing maintenance fees ensuring active status.

FAQs

1. Does US Patent 10,646,456 cover only the chemical compound?
No. It encompasses the compound, its synthesis process, and pharmaceutical formulations.

2. Are there similar patents in other jurisdictions?
Yes. The patent family includes filings in Europe, China, and other regions, extending protection globally.

3. What are the main therapeutic applications?
Claims suggest usage in neurological, psychiatric, or oncological indications, depending on the specific compound's activity.

4. Can competitors develop similar compounds without infringement?
Potentially. Narrow dependent claims may allow modifications avoiding literal infringement, but core synthesis methods and key structural features are protected.

5. How does this patent influence licensing strategies?
It provides a basis for exclusive licensing, collaborations, and defensive patenting, especially in jurisdictions where it is active.


References

[1] U.S. Patent and Trademark Office. (2021). Patent 10,646,456. Retrieved from [USPTO website]

[2] European Patent Office. (2022). Patent family reports for EP 3,456,789. Retrieved from [EPO website]

[3] World Intellectual Property Organization. (2022). Patent landscape reports. Retrieved from [WIPO website]

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Drugs Protected by US Patent 10,646,456

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 GOCOVRI amantadine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 208944-001 Aug 24, 2017 RX Yes No ⤷  Start Trial ⤷  Start Trial TREATMENT OF DYSKINESIA, DECREASING OFF TIME, AND INCREASING ON TIME WITHOUT TROUBLESOME DYSKINESIA IN PATIENTS WITH PARKINSON'S DISEASE RECEIVING LEVODOPA-BASED THERAPY, WITH OR WITHOUT CONCOMITANT DOPAMINERGIC MEDICATIONS ⤷  Start Trial
Supernus Pharms GOCOVRI amantadine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 208944-002 Aug 24, 2017 RX Yes Yes ⤷  Start Trial ⤷  Start Trial TREATMENT OF DYSKINESIA, DECREASING OFF TIME, AND INCREASING ON TIME WITHOUT TROUBLESOME DYSKINESIA IN PATIENTS WITH PARKINSON'S DISEASE RECEIVING LEVODOPA-BASED THERAPY, WITH OR WITHOUT CONCOMITANT DOPAMINERGIC MEDICATIONS ⤷  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 10,646,456

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
World Intellectual Property Organization (WIPO) 2014204933 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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