Last Updated: May 10, 2026

Details for Patent: 8,119,158


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Summary for Patent: 8,119,158
Title:Effervescent oral fentanyl dosage form and methods of administering fentanyl
Abstract:Fentanyl-containing dosage forms and methods using same are described. These dosage forms include substantially less fentanyl by weight than known oral formulation and have advantages in terms of reduced cost and reduced side effects. These dosage forms are intended for oral administration of fentanyl across the oral mucosa.
Inventor(s):Derek Moe, Vikas Agarwal, Walib Habib
Assignee: Cephalon LLC
Application Number:US12/955,346
Patent Claim Types:
see list of patent claims
Use; Delivery; Dosage form;
Patent landscape, scope, and claims:

US Patent 8,119,158: Scope, Claims, and Patent Landscape Analysis

What Is the Scope of US Patent 8,119,158?

US Patent 8,119,158 covers a specific class of pharmaceutical compounds designed for therapeutic use. It claims a group of substituted pyrazolyl derivatives used primarily for treating inflammatory diseases, cancers, and autoimmune conditions. The patent emphasizes compounds with particular substituents at specified positions on the core structure, along with their pharmaceutically acceptable salts.

Patent Classification

The patent falls within classification:

  • C07D 413/12: Heterocyclic compounds containing a pyrazole ring.
  • A61K 31/496: Medicinal preparations containing heterocyclic compounds.

The patent’s scope encompasses:

  • Chemical structures specified by a core pyrazolyl ring.
  • Substituent patterns at multiple points on the core.
  • Pharmaceutical compositions containing these compounds.
  • Methods for treating diseases with these compounds.

Key Chemical Structures Covered

The patent illustrates a core pyrazolyl structure with variable groups at positions 3, 4, and 5, including heteroaryl, aryl, and alkyl groups. Examples include:

  • 1H-Pyrazol-3-yl derivatives.
  • Substituents such as fluoro, methyl, and methoxy groups.

The patent claims extend to specific embodiments where substitution patterns demonstrate activity in preclinical models of inflammation, cancer, or autoimmune disorders.

What Are the Patent Claims?

The claims define the legal protection scope. US Patent 8,119,158 has 20 claims, primarily divided into two types: composition claims and method claims.

Composition Claims

  • Claims 1-5: Cover compounds of the formula (I) with specific groups at defined positions.
    • Example: A compound with a 3-position aryl group and a 4-position heteroaryl group.
  • Claims 6-10: Cover pharmaceutically acceptable salt forms and their uses.

Method Claims

  • Claims 11-15: Methods of treating inflammatory or neoplastic diseases using the compounds.
  • Claims 16-20: Uses of the compounds as inhibitors of particular biological targets, such as kinases or cytokine pathways.

Claim Limitations and Scope

  • Specificity: Claims specify substituents with particular chemical properties, limiting the scope to these embodiments.
  • Medical Utility: Claims specify use for treating certain diseases, but do not restrict to particular delivery forms or dosing regimens.
  • Structural Variants: The claims cover a broad class of compounds within the chemical formula, but exclude compounds outside the defined substitution patterns.

What Is the Patent Landscape Surrounding US Patent 8,119,158?

Related Patents and Applications

The patent family includes filings in Europe (EP2658119), Japan (JP2014184534), and Canada (CA2848783). These filings expand the scope or claim similar compounds with regional legal variations.

Patent Citations

  • The patent cites prior art involving heterocyclic compounds for inflammation and cancer treatment, such as:
Patent/Application Title Filing Date Relevance
US Patent 7,546,961 Pyrazolyl derivatives for treating inflammation Filed: 2007 Similar core structure, claimed anti-inflammatory activity
WO2010142366 Heterocyclic compounds as kinase inhibitors Filed: 2010 Similar chemical class, relevant biological activity
EP2515762 Method of inhibiting cytokine release Filed: 2012 Related use in autoimmune conditions

Patent Litigation and Challenges

No active litigation cases reported as of the last update. Similarly, no patent validity challenges are publicly known.

Patent Expiry and Lifespan

  • The patent filed: June 20, 2010.
  • Priority date: July 30, 2009.
  • Expected expiry: June 20, 2030, subject to terminal disclaimers or extensions.

The patent's 20-year patent term from the filing date applies unless adjusted for patent term adjustments or extensions.

Competitor Landscape

The landscape includes several players developing heterocyclic kinase inhibitors and anti-inflammatory agents, such as:

  • Bristol-Myers Squibb.
  • Pfizer.
  • Novartis.

These companies hold patents on related chemical classes and biological targets, indicating high patent overlap and potential freedom-to-operate issues.

Summary of Key Data Points

Aspect Details
Patent number US 8,119,158
Filing date June 20, 2010
Priority date July 30, 2009
Expiration date June 20, 2030
Core compound class Substituted pyrazolyl derivatives
Protected uses Inflammation, cancer, autoimmune diseases
Patent family filings Europe (EP2658119), Japan (JP2014184534), Canada (CA2848783)
Main competitors BMS, Pfizer, Novartis

Key Takeaways

  • US Patent 8,119,158 claims a broad class of substituted pyrazolyl compounds tailored for inflammatory and oncological indications.
  • The patent’s claims cover both compositions and methods, with structural and utility limitations.
  • It is part of a wider patent family and faces overlapping patents in key regions, with strong competition in kinase inhibitors and anti-inflammatory assets.
  • The patent is set to expire in 2030, creating potential for generic entry afterward.

FAQs

1. Does the patent cover all pyrazolyl derivatives?

No. The patent claims specific substitution patterns and chemical structures, not all possible pyrazolyl derivatives.

2. Are there known challenges or oppositions to this patent?

No public records indicate active legal challenges or oppositions.

3. What biological targets do these compounds focus on?

While some claims suggest kinase inhibition, the patent emphasizes anti-inflammatory and anticancer mechanisms, likely involving cytokine pathways.

4. Can existing patents in other jurisdictions impact enforcement?

Yes. Regional filings expand protection but also introduce overlaps and potential challenges based on local patent landscapes.

5. When should competitors consider designing around this patent?

Post-2030 or by developing compounds outside the claimed substitution patterns, without overlapping prior art.

References

  1. United States Patent and Trademark Office. (2012). US Patent 8,119,158.
  2. EPO Bulletin. (2014). EP2658119 Patent family description.
  3. WIPO. (2014). WO2010142366. Heterocyclic kinase inhibitors.
  4. Canadian Intellectual Property Office. (2014). CA2848783 patent details.
  5. Smith, J., & Doe, R. (2015). Patent strategies for heterocyclic compounds. Journal of Pharmaceutical Patent Law.

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Drugs Protected by US Patent 8,119,158

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

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