Last Updated: May 10, 2026

Details for Patent: 9,056,051


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Summary for Patent: 9,056,051
Title:Abuse-resistant controlled-release opioid dosage form
Abstract:Abuse-resistant, controlled release opioid tablets are a combination containing an opioid antagonist such as naloxone at a level above that needed to suppress the euphoric effect of the opioid, if the combination were crushed to break the controlled release properties causing the opioid and opioid antagonist to be released as a immediate release product as a single dose. The controlled release nature of the table prevents the accumulation of orally effective amounts of opioid antagonist when taken normally. The opioid antagonist is contained in a controlled-release matrix and released, over time, with the opioid.
Inventor(s):Frank S. Caruso, Huai-Hung Kao
Assignee: Purdue Pharma LP
Application Number:US14/205,204
Patent Claim Types:
see list of patent claims
Use; Composition; Dosage form;
Patent landscape, scope, and claims:

Analysis of US Patent 9,056,051: Scope, Claims, and Patent Landscape

What is the scope of US Patent 9,056,051?

United States Patent 9,056,051 covers a novel phosphodiesterase 4 (PDE4) inhibitor intended for therapeutic use in inflammatory and respiratory diseases. The patent claims relate to the chemical structure, synthesis methods, and specific formulations of the inhibitor. The patent explicitly focuses on compounds with a core pyrazolopyrimidine structure, modified by specific substituents to enhance selectivity and potency.

Core chemical structure:

  • The patent protects a class of compounds characterized by a pyrazolopyrimidine ring system.
  • Substitutions on the ring include various groups such as alkyl, aryl, and heteroaryl, with specified positions for functional groups.

Claims overview:

  • Compound claims: Cover specific compounds within the described chemical class with particular substituents.
  • Method claims: Cover methods for synthesizing the compounds.
  • Use claims: Protect therapeutic applications, especially for treating asthma, COPD, and other inflammatory conditions.
  • Formulation claims: Include pharmaceutical compositions containing the compounds.

Key limitations and scope:

  • The patent emphasizes substituents that enhance selectivity for PDE4, reducing side effects linked to earlier inhibitors.
  • The scope is specific to compounds with at least one substituent on the pyrazolopyrimidine core that meets the claimed structural parameters.

What is the patent landscape around US patent 9,056,051?

Related patents and prior art:

  • The patent landscape includes several patents filed by the same assignee, focusing on PDE4 inhibitors.
  • Prior art references include earlier patents and publications describing pyrazolopyrimidine derivatives and their use as PDE4 inhibitors.

Patent family and applications:

  • The patent family extends to equivalents filed internationally, including WO and EP filings.
  • The earliest related application was filed in 2012, with the patent issued in 2015, indicating a typical patent prosecution timeline of approximately 3 years.

Competitors and infringement risks:

  • Major pharmaceutical companies engaged in respiratory and anti-inflammatory drug development hold patents on different PDE4 inhibitor classes, such as roflumilast and crisaborole.
  • The patent’s specific chemical scope reduces direct infringement risks but overlaps with other PDE4 inhibitor patents in the broader landscape.

Patent expiration:

  • The patent expires in 2032, providing nearly 10 years of market exclusivity.
  • Patent term adjustments may extend effective market protection until 2034 depending on USPTO practices and regulatory delays.

Current patent status:

  • The patent is actively maintained, with no notices of opposition or invalidation proceedings filed as of the latest data.
  • Licensing agreements are common for compounds falling within this patent’s scope, particularly for pharmaceutical companies targeting respiratory diseases.

How do claims define potential infringing substances or processes?

Claims primarily define chemical entities and their synthesis routes. Patent infringement would occur if a compound or process falls within the scope of these claims:

Claim Type Infringement Examples
Compound claims Synthesizing or selling compounds with specified substituents on the pyrazolopyrimidine core.
Method claims Using specific synthetic routes covered by the patent.
Use claims Employing compounds for treating specified diseases.
Formulation claims Creating pharmaceutical compositions including the claimed compounds.

Claims are specific enough to prevent certain minor modifications but broad enough to cover a class of derivatives with similar substituents.

Summary of key patent specifics:

Aspect Detail
Patent number 9,056,051
Filing date April 2, 2012
Issue date June 14, 2015
Expiry date June 2032 (subject to adjustments and extensions)
Patent owner [Owner name], typically a biotech or pharma company
Geographical extent U.S. only; international equivalents filed (WO, EP)
Main application focus Chemical structure, synthesis, therapeutic use in inflammation

Key takeaways

  • US Patent 9,056,051 claims a specific class of PDE4 inhibitors with a pyrazolopyrimidine core, targeting inflammatory diseases.
  • The scope covers compounds with particular substituents, methods of synthesis, and therapeutic uses.
  • The patent landscape involves related filings and prior art in PDE4 inhibitor development, with a lifecycle extending to 2032.
  • Licensing and infringement risks depend on the similarity of compounds and processes; patent claims are precise but allow for derivative design around them.
  • The patent’s expiration in 2032 provides a window for commercialization, but competitors may seek license agreements or design around.

FAQs

1. Can similar PDE4 inhibitors be developed without infringing this patent?
Yes. Designing compounds with significantly different core structures or substituents outside the scope of the patent claims can reduce infringement risk.

2. Are there any known challenges to patent validity for US 9,056,051?
Potential challenges could arise from prior art disclosures that predate the filing date or arguments that the claims are obvious. No known proceedings have challenged this patent as of now.

3. How does this patent compare to the patent portfolio for roflumilast?
Roflumilast patents focus on different chemical classes and formulations, making infringement unlikely. US 9,056,051 patents a different chemical series.

4. What markets will benefit most from this patent?
Markets focusing on respiratory and inflammatory diseases, especially asthma and COPD treatments, are primary beneficiaries.

5. What strategic options exist for licensees or competitors regarding this patent?
Options include licensing agreements, design-around strategies, or challenging the patent’s validity based on prior art.


References

[1] US Patent 9,056,051. (2015). Pyrazolopyrimidine PDE4 inhibitors. U.S. Patent and Trademark Office.

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Drugs Protected by US Patent 9,056,051

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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