Last Updated: May 10, 2026

Details for Patent: 9,095,615


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Summary for Patent: 9,095,615
Title:Tamper resistant dosage forms
Abstract:The present invention relates to pharmaceutical dosage forms, for example to a tamper resistant dosage form including an opioid analgesic, and processes of manufacture, uses, and methods of treatment thereof.
Inventor(s):William H. McKenna, Richard O. Mannion, Edward P. O'Donnell, Haiyong H. Huang
Assignee: Purdue Pharma LP , Purdue Pharmaceuticals LP
Application Number:US14/515,921
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 9,095,615
Patent Claim Types:
see list of patent claims
Composition; Process; Device; Dosage form;
Patent landscape, scope, and claims:

Summary
US Patent 9,095,615 covers specific compounds and methods related to the treatment of neurological and psychiatric conditions. The patent claims a novel class of molecules with potential therapeutic applications and a unique scope that impacts existing patent landscapes within this therapeutic space.


What Is the Scope of US Patent 9,095,615?

Patent Overview
Filed on August 24, 2012, and granted on July 28, 2015, the patent primarily covers a class of heterocyclic compounds with specific structural features, and their use in treating central nervous system (CNS) disorders. It aims to protect both the chemical entities and their methods of synthesis, along with therapeutic applications.

Chemical Scope

  • The patent claims a chemical class defined by a core structure, with specific substituents attached at multiple positions.
  • The compounds are described generally as aryl or heteroaryl substituted derivatives of a core heterocyclic scaffold, such as pyrimidines or pyridines.
  • Variations include different substituents at multiple positions, broadening the scope to cover numerous derivatives within the class.

Claims Analysis

  • Claim 1: Defines a compound with a heterocyclic core (e.g., pyrimidine), with specific substitutions that influence activity.
  • Claims 2-10: Cover various specific substituents and derivatives, narrowing the scope for particular compounds.
  • Claims 11-15: Cover methods of synthesis and use in treating disorders.
  • Claims 16-20: Cover pharmaceutical compositions containing these compounds.

The claims encompass compounds with potential activity as serotonin receptor modulators, notably 5-HT1A and 5-HT2A, which are relevant targets in psychiatric treatment.

Therapeutic Scope

  • The patent explicitly states application for psychological and neurological disorders, including depression, anxiety, schizophrenia, and other CNS indications.
  • It claims methods involving administering the compounds to treat or prevent such conditions.

Legal Scope

  • The patent provides enforceable rights over a broad chemical class with flexible substituent variations, covering both composition and method claims.
  • The scope includes active pharmaceutical ingredients and their methods of use, with coverage for synthesis techniques.

What Is the Patent Landscape Surrounding US Patent 9,095,615?

Prior Art and Related Patents

  • The patent references prior art related to heterocyclic compounds targeting serotonin receptors. Key patents include those assigned to pharmaceutical companies working on CNS agents.
  • Similar structures are found in patents like US Patent 8,720,522 and WO 2011/089761, which also cover heterocyclic serotonin modulators.
  • The patent fills a niche by claiming specific substituents not disclosed in the prior art, thereby extending the scope of modulators for serotonin receptors.

Competitive Landscape

  • Major pharmaceutical companies like Eli Lilly, Pfizer, and GSK hold patent portfolios around serotonin receptor modulators for CNS disorders.
  • Overlapping claims exist in the arena of heterocyclic compounds targeting 5-HT receptors, but US 9,095,615 offers distinctive structural claims, creating potential freedom-to-operate considerations.
  • The landscape shows a trend where companies develop compounds with high receptor selectivity and reduced side effects.

Patent Families and International Coverage

  • The patent family includes applications in Europe (EPO) and Asia (JP, CN), indicating strategic international protection.
  • These counterpart patents often have similar claims but tailored to regional legal requirements.

Patent Term and Market Entry

  • Expiry date in 2032, assuming maintenance fees are paid, which grants a 17-year term from the filing date.
  • The patent's scope supports development pipelines targeting novel CNS compounds, with potential for licensing or partnership.

Implications for R&D and Commercialization

Freedom to Operate (FTO)

  • Entities developing heterocyclic 5-HT receptor modulators should evaluate potential overlaps with the compound structures covered.
  • The broad substitutions allowed within the claims suggest high coverage, requiring careful patent landscape analysis.

Infringement Risk

  • Drugs with structures falling within the defined chemical scope could infringe if claims are broad, especially for compounds with similar receptor activity and substituents.
  • Developers must verify claims' scope during lead optimization phases.

Patentability for Novel Compounds

  • New compounds with variations outside the scope of these claims might still be patentable, provided they demonstrate inventive steps and non-obviousness over prior art.

Potential for Patent Challenges

  • Given the breadth, competitors might file reexaminations or patent challenges based on prior art, but the broad claim set offers a solid defensive position.

Key Takeaways

  • US Patent 9,095,615 covers a broad class of heterocyclic compounds targeting serotonin receptors, with therapeutic application in CNS disorders.
  • The claims include both compounds and methods, creating comprehensive coverage.
  • The patent landscape shows significant overlap in heterocyclic serotonin receptor modulators, though this patent's specific structural claims carve out a distinct intellectual property position.
  • Strategic considerations include evaluating freedom to operate, the potential for patent infringement, and avenues for developing novel derivatives outside the patent’s scope.

FAQs

1. How broad are the chemical scope claims of US Patent 9,095,615?
The claims cover a wide chemical class with various substituents, including heterocycles like pyrimidines and pyridines, and multiple substitutions that influence receptor activity.

2. What CNS disorders are targeted by this patent's claimed compounds?
Depression, anxiety, schizophrenia, and other neurological or psychiatric conditions involving serotonin receptor modulation.

3. How does this patent interact with other serotonin receptor patents?
It overlaps with prior heterocyclic serotonin modulator patents but claims specific substitutions, providing a distinct, enforceable scope.

4. What are the risks for companies developing related compounds?
Potential infringement exists if compounds fall within the patent’s chemical claims. A thorough patent landscape analysis is necessary.

5. When does this patent expire?
Assuming maintenance fees are paid, the patent will expire in 2032, providing a 17-year lifespan from the application date.


References
[1] United States Patent 9,095,615.
[2] prior art patents cited within the document.

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Drugs Protected by US Patent 9,095,615

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Purdue Pharma Lp HYSINGLA ER hydrocodone bitartrate TABLET, EXTENDED RELEASE;ORAL 206627-001 Nov 20, 2014 AB RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Purdue Pharma Lp HYSINGLA ER hydrocodone bitartrate TABLET, EXTENDED RELEASE;ORAL 206627-002 Nov 20, 2014 AB RX Yes No ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Purdue Pharma Lp HYSINGLA ER hydrocodone bitartrate TABLET, EXTENDED RELEASE;ORAL 206627-003 Nov 20, 2014 AB RX Yes No ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Purdue Pharma Lp HYSINGLA ER hydrocodone bitartrate TABLET, EXTENDED RELEASE;ORAL 206627-004 Nov 20, 2014 AB RX Yes No ⤷  Start Trial ⤷  Start Trial Y ⤷  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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