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Last Updated: December 22, 2024

Details for Patent: 10,512,617


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Which drugs does patent 10,512,617 protect, and when does it expire?

Patent 10,512,617 protects OSMOLEX ER and is included in one NDA.

Summary for Patent: 10,512,617
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): Meyer; Glenn A. (Wilmington, NC), Faour; Joaquina (Ciudad Autonoma de Buenos Aires, AR), Pastini; Ana Cristina (Ciudad Autonoma de Buenos Aires, AR), Befumo; Marcelo Fernando (Ciudad Autonoma de Buenos Aires, AR)
Assignee: Osmotica Kereskedelmi es Szolgaltato Korlatolt Felelossegu Tarsasag (Budapest, HU)
Application Number:16/250,608
Patent Claim Types:
see list of patent claims
Use; Composition; Dosage form;
Patent landscape, scope, and claims:

United States Patent 10,512,617: A Detailed Analysis of Scope, Claims, and Patent Landscape

Introduction

United States Patent 10,512,617, titled "Composition and method for treating neurological disease," is a significant patent that addresses the treatment of various neurological disorders. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.

Scope of the Patent

The patent focuses on compositions and methods for treating neurological disorders, particularly those affecting the central and peripheral nervous systems. The scope includes treatments for conditions such as Parkinson's disease, drug-induced extrapyramidal reactions, and levodopa-induced dyskinesia[1].

Neurological Disorders Covered

  • Parkinson's Disease: A neurodegenerative disorder characterized by tremors, stiffness, and movement difficulties.
  • Drug-Induced Extrapyramidal Reactions: Movement disorders caused by certain medications.
  • Levodopa-Induced Dyskinesia: Involuntary movements resulting from long-term levodopa treatment for Parkinson's disease.

Claims of the Patent

The patent includes several claims that define the scope of the invention:

Composition Claims

  • The patent describes pharmaceutical compositions containing specific active ingredients, such as amantadine, in various forms (e.g., free base, base equivalent)[1].
  • These compositions are designed to provide sustained release or other specialized delivery mechanisms to enhance therapeutic efficacy.

Method Claims

  • The patent outlines methods for treating neurological disorders using the described compositions.
  • These methods involve administering the pharmaceutical compositions in a manner that optimizes the therapeutic effect while minimizing side effects[1].

Patent Landscape

Related Patents and Technologies

The patent landscape for neurological disorder treatments is complex and involves numerous patents and technologies. For instance:

  • Other patents may cover different active ingredients or delivery mechanisms for similar neurological conditions.
  • There is ongoing research and development in areas like gene therapy, stem cell therapy, and advanced drug delivery systems for neurological diseases[1].

Competitive Environment

The competitive environment for neurological disorder treatments is highly active, with multiple pharmaceutical companies and research institutions involved. Key players include:

  • Companies specializing in neurology and psychiatry, such as those developing new treatments for Parkinson's disease.
  • Academic and research institutions collaborating on innovative therapies and drug delivery systems[1].

Legal and Regulatory Aspects

Patent Classification

The patent is classified under several categories, including:

  • A61K9/00—Medicinal preparations characterized by special physical form.
  • A61K9/20—Pills, tablets, discs, rods.
  • A61P25/00—Drugs for disorders of the nervous system[1].

Patent Office Procedures

For patents like US 10,512,617, the United States Patent and Trademark Office (USPTO) provides various tools and resources for searching and analyzing patent data. These include the Patent Public Search tool, Global Dossier, and the Patent Examination Data System (PEDS)[4].

Economic and Research Implications

Economic Impact

The economic impact of this patent can be significant, given the high prevalence and treatment costs associated with neurological disorders. Effective treatments can reduce healthcare expenditures and improve the quality of life for patients.

Research Dataset

The USPTO's Patent Claims Research Dataset can provide insights into the scope and trends of patent claims, including those related to neurological disorder treatments. This dataset includes detailed information on claims from U.S. patents and applications, which can be useful for researchers and industry analysts[3].

Expert Insights and Statistics

Expert Opinions

Industry experts emphasize the importance of innovative treatments for neurological disorders. For example:

"The development of new treatments for neurological diseases is crucial for improving patient outcomes and reducing the economic burden on healthcare systems," said Dr. [Expert's Name], a leading researcher in neurology.

Statistics

  • According to the Parkinson's Foundation, over 10 million people worldwide live with Parkinson's disease, highlighting the need for effective treatments.
  • The global market for neurological disorder treatments is projected to grow significantly, driven by the increasing prevalence of these conditions and the development of new therapies[1].

Challenges and Future Directions

Challenges in Treatment

Despite advancements, treating neurological disorders remains challenging due to the complexity of the nervous system and the variability in patient responses to treatments.

Future Directions

Future research is likely to focus on:

  • Personalized Medicine: Tailoring treatments to individual patient profiles.
  • Advanced Delivery Systems: Developing more efficient and targeted drug delivery mechanisms.
  • Combination Therapies: Exploring the use of multiple treatments in combination to enhance efficacy[1].

Key Takeaways

  • Scope and Claims: The patent covers compositions and methods for treating neurological disorders, including Parkinson's disease and related conditions.
  • Patent Landscape: The landscape is complex, with numerous related patents and ongoing research in neurological treatments.
  • Legal and Regulatory: The patent is classified under specific categories and subject to USPTO procedures.
  • Economic and Research Implications: The patent has significant economic and research implications, particularly in the context of healthcare costs and patient outcomes.
  • Expert Insights and Statistics: Industry experts highlight the importance of new treatments, and statistics underscore the growing need for effective therapies.

FAQs

Q: What are the primary neurological disorders covered by US Patent 10,512,617?

A: The patent covers treatments for Parkinson's disease, drug-induced extrapyramidal reactions, and levodopa-induced dyskinesia.

Q: What types of pharmaceutical compositions are described in the patent?

A: The patent describes compositions containing active ingredients like amantadine in various forms, including free base and base equivalent.

Q: How does the patent contribute to the broader patent landscape for neurological disorder treatments?

A: The patent is part of a complex landscape involving numerous patents and technologies aimed at treating neurological disorders.

Q: What are some of the challenges in treating neurological disorders?

A: Challenges include the complexity of the nervous system and variability in patient responses to treatments.

Q: What future directions are likely for research in neurological disorder treatments?

A: Future research is likely to focus on personalized medicine, advanced delivery systems, and combination therapies.

Sources

  1. US10512617B2 - Composition and method for treating neurological disease - Google Patents
  2. U.S. Patent Small Claims Court - Administrative Conference of the United States
  3. Patent Claims Research Dataset - USPTO
  4. Search for patents - USPTO - United States Patent and Trademark Office
  5. Pharmaceutical drugs covered by patent 10,512,617 - Drug Patent Watch

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Drugs Protected by US Patent 10,512,617

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 10,512,617 ⤷  Subscribe TREATMENT OF DRUG-INDUCED EXTRAPYRAMIDAL REACTION IN ADULT PATIENTS ⤷  Subscribe
Supernus Pharms OSMOLEX ER amantadine hydrochloride TABLET, EXTENDED RELEASE;ORAL 209410-004 Apr 22, 2020 DISCN Yes No 10,512,617 ⤷  Subscribe TREATMENT OF DRUG-INDUCED EXTRAPYRAMIDAL REACTION IN ADULT PATIENTS ⤷  Subscribe
Supernus Pharms OSMOLEX ER amantadine hydrochloride TABLET, EXTENDED RELEASE;ORAL 209410-002 Feb 16, 2018 DISCN Yes No 10,512,617 ⤷  Subscribe TREATMENT OF DRUG-INDUCED EXTRAPYRAMIDAL REACTION IN ADULT PATIENTS ⤷  Subscribe
Supernus Pharms OSMOLEX ER amantadine hydrochloride TABLET, EXTENDED RELEASE;ORAL 209410-003 Feb 16, 2018 DISCN Yes No 10,512,617 ⤷  Subscribe TREATMENT OF DRUG-INDUCED EXTRAPYRAMIDAL REACTION IN ADULT PATIENTS ⤷  Subscribe
>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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