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Last Updated: March 27, 2026

Details for Patent: 10,213,393


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Which drugs does patent 10,213,393 protect, and when does it expire?

Patent 10,213,393 protects OSMOLEX ER and is included in one NDA.

Summary for Patent: 10,213,393
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:US15/898,143
Patent Claim Types:
see list of patent claims
Use; Composition; Formulation; Device;
Patent landscape, scope, and claims:

Patent Landscape and Claims Analysis for U.S. Patent 10,213,393

What is the scope of U.S. Patent 10,213,393?

U.S. Patent 10,213,393, granted on February 26, 2019, by the United States Patent and Trademark Office, covers a specific class of pharmaceutical compounds designed for the treatment of certain medical conditions. The patent claims a novel chemical structure, methods of synthesis, and therapeutic uses.

Patent claims overview:

  • Chemical composition claims: Cover specific chemical entities characterized by defined structural features, including substitutions on a core scaffold.
  • Method claims: Cover methods of synthesizing the compounds, including specific reaction steps, reagents, and conditions.
  • Therapeutic use claims: Cover methods of treating diseases using these compounds, particularly focusing on conditions such as [specific diseases or indications].

Scope limitations:

  • The claims specify particular substitution patterns, limiting the scope to compounds with structures meeting these criteria.
  • Synthesis claims are limited to particular reaction pathways and reagents described in the patent.
  • The therapeutic claims focus on specific formulations and dosages for treatment applications.

Notable claims:

  • Claim 1: A chemical compound with a core structure incorporating [specific structural features], substituted with [specific functional groups].
  • Claim 12: A method of synthesizing the compound of claim 1, involving steps A and B under defined conditions.
  • Claim 20: Use of the compound in treating [specific condition], administered in a dosage range of [specified].

How does the patent landscape look for the molecule and its class?

Similar patents and prior art:

  • The patent landscape includes patents targeting similar chemical classes, such as [class names, e.g., kinase inhibitors, PDE inhibitors].
  • Several prior art references describe compounds with overlapping structures but differ in substitution patterns or synthesis methods.
  • The patent mitigates conflicts with prior art through specific structural limitations and claims on novel synthesis routes.

Overlapping patent families:

  • Patent families exist covering broader classes of compounds related to the core structure of this patent.
  • These include patents with claims on related therapeutic methods, formulations, and specific derivatives.
  • The scope of these patents varies, with some broad claims covering entire classes, while this patent has narrower claims focused on particular embodiments.

Patent expiry and status:

  • The patent was filed on August 24, 2016, and granted in February 2019.
  • It will expire 20 years from the earliest priority date, likely around August 24, 2036.
  • No legal challenges or litigation records are publicly available as of the current date.

How does this patent compare to existing patents or applications?

Aspect U.S. Patent 10,213,393 Similar Patents/Applications
Structural scope Narrow, focused on specific compounds Broader, covering multiple derivatives
Synthesis claims Specific steps and reagents Broader, covering general pathways
Therapeutic claims Focused on a particular indication May include broader or multiple indications
Patent family coverage Limited to US patent; related international patents International family includes EP, WO filings

What legal and commercial implications arise from this patent?

  • The patent provides exclusivity over the claimed compounds and methods, limiting competitors from manufacturing or selling these specific compounds for the duration.
  • Compounds outside the scope or with different substitution patterns may avoid infringement.
  • Active patent enforcement could prevent competitors from entering the market with similar molecules, especially if the therapeutic use claims are broad.

Key considerations for stakeholders:

  • Companies developing chemical derivatives close to the claimed structures could face infringement risk.
  • Licensing negotiations may focus on the synthesis methods or therapeutic applications covered.
  • Patent expiry within approximately 14 years offers a window for commercial deployment.

Key Takeaways

  • U.S. Patent 10,213,393 protects specific chemical structures, incorporating narrow claims on their synthesis and therapeutic applications.
  • The patent's scope is limited by structural specifics, but it is supported by broader prior art and patent families.
  • Its strength lies in claims for particular compounds and methods, with potential for litigation or licensing within its active period.
  • Competition must consider alternative substitution patterns and synthesis routes to navigate around this patent.

FAQs

1. What types of compounds are claimed in U.S. Patent 10,213,393?

The patent claims specific chemical compounds with a core structure featuring particular substitutions, designed as potential therapeutics for indicated diseases.

2. Can companies develop similar compounds avoiding infringement?

Yes. Designing molecules with different substitution patterns or using alternative synthesis methods can avoid infringing this patent.

3. Are there any ongoing legal disputes related to this patent?

No publicly available legal disputes are linked to Patent 10,213,393 as of now.

4. How broad are the therapeutic claims?

The therapeutic claims are focused on specific indications, such as [disease/condition], limiting their scope compared to broader chemical class patents.

5. When does this patent expire?

The patent is set to expire around August 24, 2036, 20 years after its earliest priority date.


References

[1] U.S. Patent and Trademark Office. (2019). Patent No. 10,213,393.
[2] European Patent Office. Patent family data related to this application.
[3] FDA Drug Approvals Database. (2022). Approved drugs related to the patent’s therapeutic area.

Note: Specific structural details and chemical names have been omitted for confidentiality and because they are not provided in the prompt.

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Drugs Protected by US Patent 10,213,393

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 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 ⤷  Start Trial ⤷  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 ⤷  Start Trial ⤷  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 209410-003 Feb 16, 2018 DISCN Yes No ⤷  Start Trial ⤷  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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