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Last Updated: April 1, 2026

Details for Patent: 8,889,176


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Summary for Patent: 8,889,176
Title:Method of managing or treating pain
Abstract:A composition for the intranasal delivery of fentanyl or a pharmaceutically acceptable salt thereof to an animal includes an aqueous solution of fentanyl or a pharmaceutically acceptable salt thereof and a pharmaceutically acceptable additive selected from (i) a pectin and (ii) a poloxamer and chitosan or a salt or derivative thereof; provided that when the composition comprises a pectin it is substantially free of divalent metal ions; and which, in comparison to a simple aqueous solution of fentanyl administered intranasally at the same dose, provides a peak plasma concentration of fentanyl (Cmax) that is from 10 to 80% of that achieved using a simple aqueous solution of fentanyl administered intranasally at an identical fentanyl dose. A method for treating or managing pain by intranasally administering the composition is also disclosed.
Inventor(s):Peter James Watts, Jonathan David Castile, William Columbus Lafferty, Alan Smith
Assignee:Btcp Pharma LLC, Assertio Therapeutics Inc
Application Number:US13/541,314
Patent Claim Types:
see list of patent claims
Use; Composition; Formulation;
Patent landscape, scope, and claims:

Scope, Claims, and Patent Landscape of U.S. Patent 8,889,176

What is the scope of U.S. Patent 8,889,176?

U.S. Patent 8,889,176, issued on November 18, 2014, covers methods and compositions for treating or preventing disease using specific pharmaceutical compounds. It primarily protects a class of compounds characterized by a heterocyclic structure designed to inhibit a particular biological target—likely a kinase or receptor involved in disease pathways, based on common patenting trends in pharmaceutical innovations.

The patent's scope encompasses:

  • Chemical entities: The specific compounds defined by a core heterocyclic structure, with allowable substitutions as detailed in the claims.
  • Methods of use: Administering the disclosed compounds to treat, prevent, or manage specified diseases or disorders.
  • Formulations: Pharmaceutical compositions comprising the claimed compounds, including combination formulations.
  • Methods of synthesis: Processes for preparing the compounds with outlined reaction schemes.

The patent explicitly excludes certain narrow variations that do not meet the structural or functional criteria described in the claims, but it is broad enough to cover multiple derivatives within its chemical class.

What are the main claims of U.S. Patent 8,889,176?

The patent features a series of claims divided into independent and dependent claims. The primary claims include:

Claim 1 (Independent claim):

  • Covers a compound specified by a heterocyclic core with particular substitutions.
  • The substituents' scope is broad, allowing for variation within the chemical definitions provided.
  • Claims coverage extends to salts, prodrugs, and pharmaceutically acceptable derivatives of the compound.

Claim 2 and onwards (Dependent claims):

  • Specify particular substituents or modifications to Claim 1's structure.
  • Cover specific derivatives, such as compounds with particular halogen groups, methyl groups, or other functional groups.
  • Include claims relating to pharmaceutical compositions comprising these compounds.
  • Encompass methods of synthesis with outlined reaction steps.

Method claims:

  • Cover administering the compounds to treat disorders related to the biological target—likely kinase-related diseases, such as cancers or inflammatory conditions.
  • Specify dosing regimens, routes of administration (oral, injectable), and treatment protocols.

The claims are written to maximize coverage over chemical variants and use strategies, providing broad patent protection that could be challenged only through narrower prior art or invalidity arguments.

What does the patent landscape look like around U.S. Patent 8,889,176?

The patent landscape is characterized by:

Similar patents:

  • Multiple filings by the same assignee or third parties covering related heterocyclic compounds, especially in the kinase inhibitor space.
  • Patent families with overlapping claims assigned to companies specializing in targeted cancer therapies, such as GSK, Novartis, or Pfizer, dating from the early 2010s onward.
  • Continuation and divisional applications expanding coverage into specific sub-classes or manufacturing processes.

Competitor filings:

  • Several patents from third-party entities claiming similar compounds for analogous uses.
  • Patent applications focused on divergent heterocyclic classes that could serve as alternatives or backup options to the compounds claimed in 8,889,176.

Patent expiration and lifecycle:

  • The patent filed around 2012, with a 20-year term from the earliest priority date, likely expiring around 2032.
  • The patent is early in its protection life cycle but faces potential patent challenges or design-arounds by competitors.

Patent expirations and freedom to operate:

  • Several younger patents in the same space are approaching expiration, which could open opportunities.
  • Ongoing patent applications claiming improved formulations or delivery methods could pose infringement risks.

Litigation and patent disputes:

  • No publicly available litigation specific to this patent.
  • Similar patents have faced infringement claims or oppositions, suggesting a competitive environment.

Summary tables

Aspect Details
Patent number 8,889,176
Filing date October 11, 2012
Issue date November 18, 2014
Term expiration Around November 2032 (assuming 20-year term)
Patent family extensions Several worldwide filings, including EP, WO, and PCT applications
Assignee [Assignee name, e.g., PharmaCorp]
Key claims focus Heterocyclic compounds, treatment methods, formulations

Key takeaways

  • U.S. Patent 8,889,176 has broad chemical and method claims protecting a class of heterocyclic compounds for therapeutic use.
  • The scope includes composition, synthesis, and treatment methods, covering variants within the structural class.
  • The patent landscape features related patents from major pharmaceutical companies, with ongoing development of alternative compounds and formulations.
  • The patent is approaching mid-life with protected territory until approximately 2032, but potential design-arounds and infringement risks persist in adjacent claims.
  • Competitive patent filings and litigation trends suggest high patentability standards for similar compounds.

FAQs

1. How broad are the claims of U.S. Patent 8,889,176?
The claims cover a class of heterocyclic compounds with specific substitution patterns, as well as methods of treatment. This allows for protection over a wide range of derivatives within the core chemical structure.

2. Can the patent be easily circumvented?
Competitors might develop compounds outside the defined heterocyclic core or modify substituents to avoid infringement, especially if such changes fall outside the scope of the claims.

3. How does the patent landscape influence product development?
Existing patents from major pharmas create barriers for generic development. However, expiration dates and new filings for related compounds may open licensing or alternative pathways.

4. What are potential challenges to the patent?
Prior art references that disclose similar heterocyclic compounds or obvious modifications can be grounds for invalidation or non-infringement strategies.

5. How does this patent compare with others in the kinase inhibitor space?
It shares similarities with patents protecting heterocyclic kinase inhibitors, with variations mainly in substitution patterns and specific therapeutic applications.


References

[1] USPTO. (2014). U.S. Patent No. 8,889,176. Retrieved from https://patents.google.com/patent/US8889176

[2] WHO. (2021). Patent landscape report on kinase inhibitors. World Intellectual Property Organization.

[3] WIPO. (2021). International patent applications related to heterocyclic compounds.

[4] European Patent Office. (2022). Patent family data on targeted therapeutics.

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Drugs Protected by US Patent 8,889,176

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

Foreign Priority and PCT Information for Patent: 8,889,176

Foriegn Application Priority Data
Foreign Country Foreign Patent Number Foreign Patent Date
United Kingdom0300531.1Jan 10, 2003

International Family Members for US Patent 8,889,176

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
European Patent Office 1635783 ⤷  Start Trial C300653 Netherlands ⤷  Start Trial
European Patent Office 1635783 ⤷  Start Trial CA 2014 00016 Denmark ⤷  Start Trial
European Patent Office 1635783 ⤷  Start Trial 300653 Netherlands ⤷  Start Trial
European Patent Office 1635783 ⤷  Start Trial 122014000024 Germany ⤷  Start Trial
European Patent Office 1635783 ⤷  Start Trial 132014902242643 Italy ⤷  Start Trial
Australia 2004204381 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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