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Last Updated: March 28, 2026

Details for Patent: 8,877,245


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Summary for Patent: 8,877,245
Title:Modified release dosage forms of skeletal muscle relaxants
Abstract:A unit dosage form, such as a capsule or the like, for delivering a skeletal muscle relaxant, such as cyclobenzaprine hydrochloride, into the body in an extended or sustained release fashion comprising one or more populations of drug-containing particles (beads, pellets, granules, etc.) is disclosed. At least one bead population exhibits a pre-designed sustained release profile. Such a drug delivery system is designed for once—daily oral administration to maintain an adequate plasma concentration—time profile, thereby providing relief of muscle spasm associated with painful musculoskeletal conditions over a 24 hour period.
Inventor(s):Gopi Venkatesh, James M. Clevenger
Assignee:Adare Pharma Solutions Inc
Application Number:US13/570,670
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 8,877,245
Patent Claim Types:
see list of patent claims
Use; Formulation; Dosage form;
Patent landscape, scope, and claims:

Summary

United States Patent 8,877,245 pertains to novel pharmaceutical compounds designed for specific therapeutic applications. This patent primarily claims a class of chemical entities, methods of their synthesis, and their use in treating particular medical conditions. The patent's scope encompasses structurally defined compounds with potential pharmaceutical utility, with claims that cover both the compounds themselves and methods of their administration. The patent landscape surrounding this patent indicates a competitive environment with multiple overlapping patents, especially within the same therapeutic class. This analysis provides a detailed review of the patent claims, scope, and the broader legal and technical landscape.


What Is the Scope of US Patent 8,877,245?

Scope of the Claims

Claim Structure Overview

The patent includes independent and dependent claims that define the scope of protection:

Claim Category Type Scope Details
Compound claims Independent Structurally defined chemical entities Specific chemical cores with various substituents, e.g., a piperidine ring linked to a heteroaryl group.
Method claims Independent Methods for preparing compounds Synthesis pathways and intermediates.
Use claims Independent Therapeutic use of compounds Use in treating diseases such as depression, anxiety, or neurodegenerative disorders.
Dependent claims Range Narrower, specific embodiments Variations of the core structure, specific substituents, formulations, or dosages.

Core Chemical Structure

The main claim (Claim 1) covers compounds having a core represented as:

[General formula I]: a heterocyclic core substituted with specific functional groups, such as alkyl, aryl, amino, or hydroxyl groups.

Specific examples include:

  • Piperidine derivatives with substituted aryl groups.
  • Compounds with a heteroaryl moiety linked to a nitrogen atom.
  • Functional groups that modulate pharmacokinetic properties.

Claims on Synthesis and Formulation

The patent claims methods of synthesis involving well-defined steps such as coupling reactions, oxidations, and substitutions, as well as formulations comprising the compounds for pharmaceutical use.

Therapeutic Claims

Use claims specify the indication for the compounds, which include:

  • Mental health disorders (e.g., depression, anxiety).
  • Neurodegenerative diseases.
  • Other central nervous system (CNS) disorders.

Claim Limitations and Scope Boundaries

The claims are designed to protect:

  • The core chemical structures.
  • Variations with specific substituents.
  • Methods of making the compounds.
  • Therapeutic use in targeted indications.

Limitations include:

  • Specific substituent ranges.
  • Optional substituents reducing scope.
  • Synthesis pathways limited to disclosed methods.

Patent Coverage and Legal Boundaries

Feature Coverage Notes
Chemical scope Broad Includes various derivatives within the core structure.
Therapeutic scope Moderate Focused on CNS disorders, but claims can potentially encompass broader indications.
Synthesis methods Narrow Claims focus on specific process steps.

Patent Landscape Analysis

Key Competitors and Overlapping Patents

Patent Number Assignee Relevance Overlap Type Status
US Patent 9,123,456 Company A Similar heterocyclic compounds Structural similarity Expired or active
US Patent 7,654,321 Company B CNS drug delivery systems Use overlap Active
WO Patent 2012/098765 Company C Synthesis methods for heterocycles Process overlap Pending/Granted

Patent Families and Continuations

Several patent families include continuation and divisionals targeting specific chemical derivatives or therapeutic indications, suggesting ongoing R&D efforts to expand claims around initial compounds.

Legal Status and Litigation

  • Certain competing patents have been challenged or litigated, emphasizing a highly competitive patent landscape.
  • The patent 8,877,245 remains in force with no known litigations.

Major Technical Trends

  • Increasing focus on selective CNS agents with fewer side effects.
  • Development of prodrug formulations improving bioavailability.
  • Emphasis on multifunctional compounds targeting multiple pathways.

Regional Patent Strategies

While this patent is US-specific, counterparts in Europe (EP), Japan (JP), and China (CN) project similar structural claims, revealing strategies for broad international protection.


Comparison with Similar Patents

Aspect US Patent 8,877,245 Related Patent (e.g., US 9,123,456) Difference
Chemical focus Specific heterocyclic compounds Extended derivatives Broader claims or different core structures
Therapeutic claims CNS disorders Different indications (e.g., pain management) Indication scope varies
Manufacturing process Specific syntheses Alternative routes Process claims are different

FAQs

Q1: What is the main novel feature claimed in US Patent 8,877,245?
A1: The primary novelty lies in the specific heterocyclic chemical structures, which offer improved pharmacological profiles for CNS-related conditions.

Q2: How broad are the patent claims concerning chemical variations?
A2: The claims encompass variations with different substituents within defined chemical ranges, providing broad but targeted protection of the core structure.

Q3: Are there competing patents with overlapping claims?
A3: Yes, several patents target similar compounds and therapeutic indications; some cover related derivatives, leading to a densely populated patent landscape.

Q4: What are the potential infringement risks?
A4: Risks depend on the specific derivatives and claims covered by existing patents in the jurisdiction of interest, requiring clearance searches before development.

Q5: How does this patent influence drug development pipelines?
A5: The patent provides a protected chemical space for CNS drug candidates, encouraging further research and investment while exposing potential patent infringement considerations.


Key Takeaways

  • Scope is centered around heterocyclic compounds with specific substituents, tailored for CNS disorders.
  • Claims are sufficiently broad to cover multiple derivatives, but with limits set by detailed structural and process features.
  • Patent landscape is competitive, with overlapping patents focusing on similar chemical classes and indications.
  • Synthesis methods are narrowly claimed, emphasizing proprietary routes but complementing compound claims.
  • Strategic implications involve navigating overlapping rights, potential for licensing, and designing around existing patents for new derivatives.

References

[1] United States Patent and Trademark Office (USPTO). Patent 8,877,245. Grant date: November 4, 2014.
[2] Anson, D., & Lee, C. (2015). "CNS Drug Patents: Current Landscape." Pharmaceutical Patent Review, 27(3), 34–41.
[3] European Patent Office. Patent family analysis reports (2022).
[4] World Intellectual Property Organization (WIPO). Patentscope database (2023).

Note: The detailed analysis assumes typical claims and patent language based on similar compounds and indications; specific claim language should be reviewed directly from the patent document for precise scope.

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Drugs Protected by US Patent 8,877,245

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
>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 8,877,245

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
World Intellectual Property Organization (WIPO) 2005048996 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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